At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Description: The QA Data Steward within Indianapolis Parenteral Manufacturing is responsible for the creation/verification of Certificates of Analysis for semi-finished and finished commercial batches. In addition, the QA Data Steward is responsible for oversight of critical data maintained within one or more automated system, such as SAP, TrackWise, QualityDocs/Veeva, and Darwin. The QA Data Steward performs impact analyses, ensures all data changes are properly documented and controlled, implements/verifies system changes, and performs system audits, where applicable, to ensure data integrity. Key Objectives/Deliverables: Provide oversight and implement/verify changes of Q-Info Records and Inspection Plans in SAP Provide oversight of the TrackWise system, including the processing of records and performance of system audits, as required Process revisions/creations of QualityDocs/Veeva Specifications, as required, per approved Change Controls and RCM Matrix revisions Process revisions/creations of Darwin product, specification, test allocation, and sampling plan master data records within the Darwin LIMS system Perform timely, accurate impact analyses for changes with impact to SAP, Veeva, and/or Darwin records Create/Verify Certificates of Analysis for semi-finished and finished commercial batches Support projects/initiatives that may impact data stewardship processes and procedures, as needed Minimum Requirements: Experience working in SAP, TrackWise, QualityDocs/Veeva, and/or Darwin Strict attention to detail and ability to maintain compliance issues and meeting critical deadlines. Overall business understanding including proposal of changes, implementation and related regulations; and pharmacopoeia requirements. Excellent written and oral communication skills, troubleshooting and investigating skills, and crisis decision-making skills. Strong organizational skills - ability to handle/prioritize multiple projects and requests. Ability to interact effectively with a variety of people - good teamwork skills. Effective training skills and ability to coach others. Familiarity with cGMPs and corporate policies and procedures. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Additional Preferences: General understanding of laboratory and/or operations techniques and terminology. Previous experience in operations, quality control, and/or regulatory. Proficient in Microsoft Word/Excel/Power Point. Education Requirements: High School Graduate or equivalent. Other Information: Shift schedule: Monday-Friday 8am-5pm Overtime may be required. May be required to support off shift activities related to operational issues. Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position. Minimal travel required May be subject to Post Offer Exam Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
May 09, 2024
Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Description: The QA Data Steward within Indianapolis Parenteral Manufacturing is responsible for the creation/verification of Certificates of Analysis for semi-finished and finished commercial batches. In addition, the QA Data Steward is responsible for oversight of critical data maintained within one or more automated system, such as SAP, TrackWise, QualityDocs/Veeva, and Darwin. The QA Data Steward performs impact analyses, ensures all data changes are properly documented and controlled, implements/verifies system changes, and performs system audits, where applicable, to ensure data integrity. Key Objectives/Deliverables: Provide oversight and implement/verify changes of Q-Info Records and Inspection Plans in SAP Provide oversight of the TrackWise system, including the processing of records and performance of system audits, as required Process revisions/creations of QualityDocs/Veeva Specifications, as required, per approved Change Controls and RCM Matrix revisions Process revisions/creations of Darwin product, specification, test allocation, and sampling plan master data records within the Darwin LIMS system Perform timely, accurate impact analyses for changes with impact to SAP, Veeva, and/or Darwin records Create/Verify Certificates of Analysis for semi-finished and finished commercial batches Support projects/initiatives that may impact data stewardship processes and procedures, as needed Minimum Requirements: Experience working in SAP, TrackWise, QualityDocs/Veeva, and/or Darwin Strict attention to detail and ability to maintain compliance issues and meeting critical deadlines. Overall business understanding including proposal of changes, implementation and related regulations; and pharmacopoeia requirements. Excellent written and oral communication skills, troubleshooting and investigating skills, and crisis decision-making skills. Strong organizational skills - ability to handle/prioritize multiple projects and requests. Ability to interact effectively with a variety of people - good teamwork skills. Effective training skills and ability to coach others. Familiarity with cGMPs and corporate policies and procedures. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Additional Preferences: General understanding of laboratory and/or operations techniques and terminology. Previous experience in operations, quality control, and/or regulatory. Proficient in Microsoft Word/Excel/Power Point. Education Requirements: High School Graduate or equivalent. Other Information: Shift schedule: Monday-Friday 8am-5pm Overtime may be required. May be required to support off shift activities related to operational issues. Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position. Minimal travel required May be subject to Post Offer Exam Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
This position will be assigned to the Cobb County Water system and provides students seeking practical experience in the environmental education field with the opportunity to work with environmental educators, learn about the profession and gain insight into the field. Training is provided, including reviewing lessons/content, shadowing, co-teaching, observation, and dialogue for each content area. This experience allows interns to work with staff to facilitate public programs across the county, including summer reading programs, education programs and service projects. Collaborates with staff to learn about department initiatives and how their project/internship aligns with these initiatives. Communicates effectively both verbally, in writing, and in presenting information. Receives and responds to inquiries, concerns, and requests from other staff. Participates in meetings and other events held by the assigned department as needed. Utilizes personal computers, standard office equipment and standard software applications, e.g., word processors, database software, and spreadsheet applications. Maintains attendance and punctuality within customary tolerances for this position. Duties may vary depending on the department the intern is assigned to. Performs other related duties as assigned. Minimum Qualifications Must be a high school senior, undergraduate, or graduate student or must have graduated within the last six months. Excellent oral and written communication skills. Depending on the type of internship the participant may be required to be a Cobb County resident. Tasks require the ability to exert light physical effort in sedentary to light work, but which may involve some lifting, carrying, pushing and/or pulling of objects and materials of light weight (5-20 pounds). Tasks may involve extended periods of time at a keyboard or workstation. Sensory Requirements Some tasks require the ability to communicate orally. Environmental Factors Essential functions are regularly performed without exposure to adverse environmental conditions. EEO Statement Cobb County is an equal opportunity employer. Cobb County Government does not discriminate on the basis of race, color, national origin, sex, religion, age or disability in employment or the provision of services.
May 16, 2024
Full time
This position will be assigned to the Cobb County Water system and provides students seeking practical experience in the environmental education field with the opportunity to work with environmental educators, learn about the profession and gain insight into the field. Training is provided, including reviewing lessons/content, shadowing, co-teaching, observation, and dialogue for each content area. This experience allows interns to work with staff to facilitate public programs across the county, including summer reading programs, education programs and service projects. Collaborates with staff to learn about department initiatives and how their project/internship aligns with these initiatives. Communicates effectively both verbally, in writing, and in presenting information. Receives and responds to inquiries, concerns, and requests from other staff. Participates in meetings and other events held by the assigned department as needed. Utilizes personal computers, standard office equipment and standard software applications, e.g., word processors, database software, and spreadsheet applications. Maintains attendance and punctuality within customary tolerances for this position. Duties may vary depending on the department the intern is assigned to. Performs other related duties as assigned. Minimum Qualifications Must be a high school senior, undergraduate, or graduate student or must have graduated within the last six months. Excellent oral and written communication skills. Depending on the type of internship the participant may be required to be a Cobb County resident. Tasks require the ability to exert light physical effort in sedentary to light work, but which may involve some lifting, carrying, pushing and/or pulling of objects and materials of light weight (5-20 pounds). Tasks may involve extended periods of time at a keyboard or workstation. Sensory Requirements Some tasks require the ability to communicate orally. Environmental Factors Essential functions are regularly performed without exposure to adverse environmental conditions. EEO Statement Cobb County is an equal opportunity employer. Cobb County Government does not discriminate on the basis of race, color, national origin, sex, religion, age or disability in employment or the provision of services.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Brand Description: Provides technical leadership for drug product manufacturing processes under development and in commercial production in the Dry Product Network. Key Objectives/Deliverables Serve as Manufacturing TS/MS representative to work with Product Development, CM&C teams, Manufacturing sites, and applicable functional areas to commercialize new dry oral solid drug products Leverage prior experience to anticipate commercial manufacturing challenges for new dry products. Work across Development and Manufacturing site(s) to implement appropriate product control strategies based on anticipated needs. Serve as the Global Molecule Steward for select oral solid dosage form drug products. Collaboratively integrate different disciplines such as engineering and analytical science on technical projects, process performance improvements, or control strategy effectiveness. Provide proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs. Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites as well as additional technical support/guidance for external manufacturing as needed. Drive appropriate shared learning, alignment and improvement across sites and network level activity according to best practices and technical principles. Ensure that experiments and technical work are well designed and appropriately rigorous. Use first principles and theoretical knowledge to define scientific approaches to support technical expectations. Utilize in depth understanding of materials, process, and product to improve product/process robustness, reduce variability, and provide improvement in control strategies across sites and technologies. Collaborate with Project Managers on key product project plans and support timely delivery of milestones with appropriate risk mitigation strategies. Leverage prior experience and knowledge as a Subject Matter Expert to collaborate with Development and manufacturing sites in the optimization of key manufacturing platforms such as continuous manufacturing. Influence Development on new product or platform topics in line with Manufacturing needs. Identify and lead the deployment of other new technology as appropriate. Author technical reports and appropriate sections of regulatory submission and responses as needed. Prepare technical aspects of other Regulatory/Quality based documents and support Regulatory reviews and inspections as needed. Remain current on external pharmaceutical manufacturing trends and innovations. Leverage these to improve strategies and applications for developing and controlling manufacturing processes. Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation. As a reviewer of technical reports, provide input on the experimental findings and conclusions. Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors. Achieve network level results for Lilly's dry products (oral solid dosage forms) that improve the business. Influence global leadership to drive improvements and resolve issues. Basic Requirements: Bachelor's Degree or higher in Chemistry, Engineering, Pharmacy, or related science. Minimum 7-10+ years of direct experience and technical expertise across multiple areas, unit operations, and platforms related to dry products (oral solid dosage forms) development, commercialization & commercial GMP-manufacturing. Additional Preferences: Demonstrated, strong technical leadership and communication skills. Communicates effectively across disciplines and types of audiences (internal and external) to influence and/or drive common understanding and appropriate actions. Ability to work well independently, as well as in teams. Provides partnership and collaboration across multiple disciplines. Ability to lead teams effectively. Demonstrated, strong analytical and problem solving abilities. Effective at integrating multiple technology disciplines to drive programs forward. Flexibility to interact with multiple partners/functions, regions, and cultures. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
May 14, 2024
Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Brand Description: Provides technical leadership for drug product manufacturing processes under development and in commercial production in the Dry Product Network. Key Objectives/Deliverables Serve as Manufacturing TS/MS representative to work with Product Development, CM&C teams, Manufacturing sites, and applicable functional areas to commercialize new dry oral solid drug products Leverage prior experience to anticipate commercial manufacturing challenges for new dry products. Work across Development and Manufacturing site(s) to implement appropriate product control strategies based on anticipated needs. Serve as the Global Molecule Steward for select oral solid dosage form drug products. Collaboratively integrate different disciplines such as engineering and analytical science on technical projects, process performance improvements, or control strategy effectiveness. Provide proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs. Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites as well as additional technical support/guidance for external manufacturing as needed. Drive appropriate shared learning, alignment and improvement across sites and network level activity according to best practices and technical principles. Ensure that experiments and technical work are well designed and appropriately rigorous. Use first principles and theoretical knowledge to define scientific approaches to support technical expectations. Utilize in depth understanding of materials, process, and product to improve product/process robustness, reduce variability, and provide improvement in control strategies across sites and technologies. Collaborate with Project Managers on key product project plans and support timely delivery of milestones with appropriate risk mitigation strategies. Leverage prior experience and knowledge as a Subject Matter Expert to collaborate with Development and manufacturing sites in the optimization of key manufacturing platforms such as continuous manufacturing. Influence Development on new product or platform topics in line with Manufacturing needs. Identify and lead the deployment of other new technology as appropriate. Author technical reports and appropriate sections of regulatory submission and responses as needed. Prepare technical aspects of other Regulatory/Quality based documents and support Regulatory reviews and inspections as needed. Remain current on external pharmaceutical manufacturing trends and innovations. Leverage these to improve strategies and applications for developing and controlling manufacturing processes. Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation. As a reviewer of technical reports, provide input on the experimental findings and conclusions. Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors. Achieve network level results for Lilly's dry products (oral solid dosage forms) that improve the business. Influence global leadership to drive improvements and resolve issues. Basic Requirements: Bachelor's Degree or higher in Chemistry, Engineering, Pharmacy, or related science. Minimum 7-10+ years of direct experience and technical expertise across multiple areas, unit operations, and platforms related to dry products (oral solid dosage forms) development, commercialization & commercial GMP-manufacturing. Additional Preferences: Demonstrated, strong technical leadership and communication skills. Communicates effectively across disciplines and types of audiences (internal and external) to influence and/or drive common understanding and appropriate actions. Ability to work well independently, as well as in teams. Provides partnership and collaboration across multiple disciplines. Ability to lead teams effectively. Demonstrated, strong analytical and problem solving abilities. Effective at integrating multiple technology disciplines to drive programs forward. Flexibility to interact with multiple partners/functions, regions, and cultures. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a Lebanon manufacturing site, and the successful candidate will help to build the overall site readiness plan to enable a successful startup into GMP manufacturing operations. Responsibilities: The Site Analytical Steward provides analytical technical support for commercialization and routine support of the Lebanon Plant Site 1 for all analytical technologies in support of the product control strategy and regulatory submissions. The Site Analytical Steward utilizes their technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvement, and completes thorough investigations of aberrant data and results. Outcomes of these activities including results, conclusions, and action plans are thoroughly and accurately documented and may be published in regulatory and/or technical documents. The position is responsible for technical mentoring of lab staff and sharing technical information and best practice within the work group and across plant sites. The Site Analytical Steward participates and influences the technical agenda of the plant or corporation. The Site Analytical Steward reviews, interprets, and releases batch results for the laboratory. When appropriately qualified, performs the holistic review of analytical results associated with a batch and issues the Certificate of Testing (CoT), when required. The Site Analytical steward leads analytical investigations/forensics, the design and execution of method development and validations, technology transfers, and equipment evaluation and qualification. They may perform non-routine lab work in support of those projects for resolution of these analytical technical issues, sample characterization, or method development, transfers, and validation. They coordinate with the QC labs in the commercialization of new products to the site for analytical methods. The Site Analytical Steward works closely with the TS/MS Molecule Steward, process teams, and overall organization and influences the technical agenda. Key Objectives/Deliverables: Comprehensive Technical Review When Certificate of Testing (CoT) is required, perform in-depth technical review and release of individual test data prior to CoT issuance for the associated batch. Certificate of Testing (CoT) Issuance For release testing of manufactured API batches, re-evaluated API, and stability test results, as well as reference standard characterization packages, an appropriately qualified technical resource performs a holistic technical assessment of all analytical testing associated with the batch prior to issuing a CoT. Production and Investigation Support Utilizes technical skills to lead or perform in-depth investigations into out of spec results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. Troubleshoot equipment and methods as required. Develop investigational testing protocols and perform testing as required. Interacts effectively with business partners to communicate, resolve issues, and gain a clear, accurate understanding of each other's requirements. Continuous Improvement Initiatives Share technical information and authors regulatory and/or technical reports and memos. Research and recommend new technologies. Training and Mentoring Perform technical training as needed. Provide coaching and mentoring to Quality Control Laboratory personnel (e.g., technical issues, root cause analysis, and investigation techniques). Provide strategic and tactical support to drive technical training into Quality Control Laboratory operations. Deviations and Change Controls Review and approve change controls and observations/deviations. Review, interpret data, document results of analyses, conclusions accurately and thoroughly in summary reports in accordance with GMP and local guidelines. Writes and publishes regulatory and/or technical reports and memos. Business Support Support management in insuring that all laboratory operations are in compliance with the applicable procedures and standards. Provide leadership for the development, improvement, implementation and execution of lab quality systems; develop content, review and approve SOPs and training as necessary. Contribute to development and implementation of Global Quality Standards for laboratories. Comply with safety standards and ensure safety programs are maintained for the laboratory. Ensure interpretation of results for process monitoring are performed and provide technical oversight. Communicate effectively in both written and oral formats within the lab as well as with external customers and business partners. Review and approve protocol-driven studies (e.g., method validations, investigational studies and method transfers). Provide quality and timely customer service. Develop and ensure execution of quality plan projects. Define and monitor productivity and continuous improvement opportunities. Execute notification to management when required by procedures or standards. Assist in business plan development and execution. Contribute to APR and process validations as required. Inspection Support Define and maintain inspection readiness activities. Interact with regulatory agencies during GMP inspections as appropriate. Method Stewardship/Benchwork Authors or contributes to Site Analytical Transfer Strategies. Method development and validation/remediation. Evaluate new technologies. Monitor method and process performance. Basic Requirements: Bachelor's degree (4-year College) in a science field related to the lab (e.g., chemistry, micro or biology) 7+ Years of QC or Analytical Development Experience with small molecules, peptides, oligonucleotides or proteins Additional Preferences: Preferred training and demonstrated proficiency in Root Cause Analysis methodology. Experience in the development and validation of analytical technologies. Experience and knowledge of cGMP requirements in drug substance manufacturing. Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic, spectroscopic, and/or microbiological assays. Ability to work in a lab environment, including wearing appropriate PPE and other safety required equipment and considerations. Deep understanding of compliance requirements and regulatory expectations. Demonstrated accuracy and proficiency in analytical skills. Demonstrated strong problem-solving and analytical thinking skills. Ability to focus on continuous improvement. Demonstrated leadership skills (good interpersonal communication skills, decision making, prioritization, mentoring, problem solving, conflict resolution). Proficiency with computer systems. Understanding of statistical tools and analysis. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. . click apply for full job details
May 14, 2024
Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a Lebanon manufacturing site, and the successful candidate will help to build the overall site readiness plan to enable a successful startup into GMP manufacturing operations. Responsibilities: The Site Analytical Steward provides analytical technical support for commercialization and routine support of the Lebanon Plant Site 1 for all analytical technologies in support of the product control strategy and regulatory submissions. The Site Analytical Steward utilizes their technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvement, and completes thorough investigations of aberrant data and results. Outcomes of these activities including results, conclusions, and action plans are thoroughly and accurately documented and may be published in regulatory and/or technical documents. The position is responsible for technical mentoring of lab staff and sharing technical information and best practice within the work group and across plant sites. The Site Analytical Steward participates and influences the technical agenda of the plant or corporation. The Site Analytical Steward reviews, interprets, and releases batch results for the laboratory. When appropriately qualified, performs the holistic review of analytical results associated with a batch and issues the Certificate of Testing (CoT), when required. The Site Analytical steward leads analytical investigations/forensics, the design and execution of method development and validations, technology transfers, and equipment evaluation and qualification. They may perform non-routine lab work in support of those projects for resolution of these analytical technical issues, sample characterization, or method development, transfers, and validation. They coordinate with the QC labs in the commercialization of new products to the site for analytical methods. The Site Analytical Steward works closely with the TS/MS Molecule Steward, process teams, and overall organization and influences the technical agenda. Key Objectives/Deliverables: Comprehensive Technical Review When Certificate of Testing (CoT) is required, perform in-depth technical review and release of individual test data prior to CoT issuance for the associated batch. Certificate of Testing (CoT) Issuance For release testing of manufactured API batches, re-evaluated API, and stability test results, as well as reference standard characterization packages, an appropriately qualified technical resource performs a holistic technical assessment of all analytical testing associated with the batch prior to issuing a CoT. Production and Investigation Support Utilizes technical skills to lead or perform in-depth investigations into out of spec results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. Troubleshoot equipment and methods as required. Develop investigational testing protocols and perform testing as required. Interacts effectively with business partners to communicate, resolve issues, and gain a clear, accurate understanding of each other's requirements. Continuous Improvement Initiatives Share technical information and authors regulatory and/or technical reports and memos. Research and recommend new technologies. Training and Mentoring Perform technical training as needed. Provide coaching and mentoring to Quality Control Laboratory personnel (e.g., technical issues, root cause analysis, and investigation techniques). Provide strategic and tactical support to drive technical training into Quality Control Laboratory operations. Deviations and Change Controls Review and approve change controls and observations/deviations. Review, interpret data, document results of analyses, conclusions accurately and thoroughly in summary reports in accordance with GMP and local guidelines. Writes and publishes regulatory and/or technical reports and memos. Business Support Support management in insuring that all laboratory operations are in compliance with the applicable procedures and standards. Provide leadership for the development, improvement, implementation and execution of lab quality systems; develop content, review and approve SOPs and training as necessary. Contribute to development and implementation of Global Quality Standards for laboratories. Comply with safety standards and ensure safety programs are maintained for the laboratory. Ensure interpretation of results for process monitoring are performed and provide technical oversight. Communicate effectively in both written and oral formats within the lab as well as with external customers and business partners. Review and approve protocol-driven studies (e.g., method validations, investigational studies and method transfers). Provide quality and timely customer service. Develop and ensure execution of quality plan projects. Define and monitor productivity and continuous improvement opportunities. Execute notification to management when required by procedures or standards. Assist in business plan development and execution. Contribute to APR and process validations as required. Inspection Support Define and maintain inspection readiness activities. Interact with regulatory agencies during GMP inspections as appropriate. Method Stewardship/Benchwork Authors or contributes to Site Analytical Transfer Strategies. Method development and validation/remediation. Evaluate new technologies. Monitor method and process performance. Basic Requirements: Bachelor's degree (4-year College) in a science field related to the lab (e.g., chemistry, micro or biology) 7+ Years of QC or Analytical Development Experience with small molecules, peptides, oligonucleotides or proteins Additional Preferences: Preferred training and demonstrated proficiency in Root Cause Analysis methodology. Experience in the development and validation of analytical technologies. Experience and knowledge of cGMP requirements in drug substance manufacturing. Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic, spectroscopic, and/or microbiological assays. Ability to work in a lab environment, including wearing appropriate PPE and other safety required equipment and considerations. Deep understanding of compliance requirements and regulatory expectations. Demonstrated accuracy and proficiency in analytical skills. Demonstrated strong problem-solving and analytical thinking skills. Ability to focus on continuous improvement. Demonstrated leadership skills (good interpersonal communication skills, decision making, prioritization, mentoring, problem solving, conflict resolution). Proficiency with computer systems. Understanding of statistical tools and analysis. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. . click apply for full job details
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Description: Senior Principal Associate - QA Site Compliance serves as the site inspection readiness steward to lead the inspection readiness program at the RTP site. The inspection readiness steward will have oversight of the inspection readiness program and processes and provide quality auditing expertise in regulation requirements for all aspects of manufacturing conducted at RTP. Key Objectives/Deliverables: Coordinates and manages regulatory inspections including logistics and data system(s). Implement and Lead the site inspection readiness program Implement and Lead the Quality Oversight program Acts as data steward and trainer for site audit data system(s) Leads inspection readiness huddles Monitor and report on the status and effectiveness of the inspection readiness program and needed improvements Perform local site impact assessments in response to Lilly site external inspection findings and external trendings in accordance with Lilly's regulatory change management program. Ensure awareness of applicable regulatory requirements and quality management system requirements throughout the organization Leads site initiatives related to quality and compliance; supports network initiatives related to quality and compliance for local implementation Serve as a quality and technical mentor/coach for interpretation and application of regulatory and global requirements for individual contributors and management at the site Lead and model behaviors foundational to strong quality culture Performs site self-inspections, as necessary Support site safety initiatives. Basic Requirements: BSc or MSc in scientific/technical discipline: chemistry, biology, microbiology, engineering or equivalent scientific/technical degree 10+ years of experience in pharmaceutical and/or medical device industry Preferred attributes but not required: Extensive knowledge of external Regulations and Lilly Quality System requirements Ability to function in a team environment as a leader and as a team member Demonstrated ability to partner/network with other sites Demonstrated participations in inspections and inspection readiness activities including acting as an audit host. Demonstrated ability to manage projects. Proficiency with computer systems. Multi product facility knowledge including parenteral drug product manufacturing, device assembly and packaging activities Good knowledge of cGMPs, ISO and quality management systems with demonstrated technical proficiency Strong communication and interpersonal skills with ability to influence multiple levels of the organization Strong self-management and organizational skills, ability to prioritize, critical decision-making skills, problem solving, mentorship and coaching skills. Self-motivation, lead the way for ensuring a fair and equitable work environment. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals Additional Information: US/OUS travel may be required Flex hours possible Site operates 24/7 - overtime may be required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
May 09, 2024
Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Description: Senior Principal Associate - QA Site Compliance serves as the site inspection readiness steward to lead the inspection readiness program at the RTP site. The inspection readiness steward will have oversight of the inspection readiness program and processes and provide quality auditing expertise in regulation requirements for all aspects of manufacturing conducted at RTP. Key Objectives/Deliverables: Coordinates and manages regulatory inspections including logistics and data system(s). Implement and Lead the site inspection readiness program Implement and Lead the Quality Oversight program Acts as data steward and trainer for site audit data system(s) Leads inspection readiness huddles Monitor and report on the status and effectiveness of the inspection readiness program and needed improvements Perform local site impact assessments in response to Lilly site external inspection findings and external trendings in accordance with Lilly's regulatory change management program. Ensure awareness of applicable regulatory requirements and quality management system requirements throughout the organization Leads site initiatives related to quality and compliance; supports network initiatives related to quality and compliance for local implementation Serve as a quality and technical mentor/coach for interpretation and application of regulatory and global requirements for individual contributors and management at the site Lead and model behaviors foundational to strong quality culture Performs site self-inspections, as necessary Support site safety initiatives. Basic Requirements: BSc or MSc in scientific/technical discipline: chemistry, biology, microbiology, engineering or equivalent scientific/technical degree 10+ years of experience in pharmaceutical and/or medical device industry Preferred attributes but not required: Extensive knowledge of external Regulations and Lilly Quality System requirements Ability to function in a team environment as a leader and as a team member Demonstrated ability to partner/network with other sites Demonstrated participations in inspections and inspection readiness activities including acting as an audit host. Demonstrated ability to manage projects. Proficiency with computer systems. Multi product facility knowledge including parenteral drug product manufacturing, device assembly and packaging activities Good knowledge of cGMPs, ISO and quality management systems with demonstrated technical proficiency Strong communication and interpersonal skills with ability to influence multiple levels of the organization Strong self-management and organizational skills, ability to prioritize, critical decision-making skills, problem solving, mentorship and coaching skills. Self-motivation, lead the way for ensuring a fair and equitable work environment. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals Additional Information: US/OUS travel may be required Flex hours possible Site operates 24/7 - overtime may be required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up. The Sterility Assurance Steward- Technical Services / Manufacturing Science (TS/MS) is a role encompasses technical leadership and advisory roles in all aspects of sterility assurance of parenteral products, including but not limited to formulation, container closure, delivery systems, processing and manufacturing environment. The Sterility Assurance Steward develops and implements a technical agenda with three primary objectives: (1) reliable, compliant manufacturing of the drug product; (2) improvement of the process control strategy, continuous optimization, development and the innovation of technologies; (3) continual deepening of the scientific understanding of sterility assurance. The technical agenda exists throughout the entire product, process and facility lifecycle. A key attribute of this position includes assessment of existing strategies to identify areas for continuous improvement and development of new strategies for sterility assurance programs, including Contamination Control Strategy, Aseptic Process Simulation, Filter Validation, Container Closure Validation, Leaks and Glove Management, Environmental Monitoring, Facility Disinfection, Gowning and Hygiene, and Sterility Assurance Risk Management programs. At the Steward level, the scientist provides leadership and influence across the Parenteral Network. The scope of the role includes syringe filling and device assembly & packaging operations for commercially manufactured products targeted for transfer to the RTP site. Key Objectives / Deliverables: Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. Use sterility assurance risk management to evaluate existing and proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination. Lead and / or participate in complex projects associated with sterility assurance programs. Lead and / or assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.) Lead major deviations for root cause analysis related to sterility assurance programs. Remain abreast of external regulatory requirements associated with sterility assurance programs. Influence revision to corporate guidance associated with sterility assurance programs. Identify and implement continuous improvement for sterility assurance programs. Provide design input related to new processes (e.g., facilities, equipment, etc.) for RTP. Represents and defends the site's sterility assurance programs during internal audits and external regulatory inspections. Assists with writing of regulatory submissions for sterility assurance programs. Create, review, approve and provide sterility assurance training for new hires and personnel from other sites. Provide technical mentorship to a less senior scientists within the TS/MS organization. Provide technical mentorship to a less senior cross-functional personnel within RTP. Provide technical consultation across the Parenteral Network. Minimum Requirements: BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline Minimum 10 years' experience in the biopharmaceutical industry Additional Preferences: Masters Degree in Microbiology, Biology or related scientific field (or equivalent work experience) preferred Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.) In depth knowledge of risk management and the understanding / ability to use risk assessment tools Ability to analyze complex data and solve problems Strong technical writing and presentation skills Teamwork / interpersonal skills ability to effectively influence Knowledge of microbiology and sterility assurance Other Information: Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required. Position will be based out of RTP site with ability to travel to Indianapolis and other global Lilly sites as required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
May 04, 2024
Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up. The Sterility Assurance Steward- Technical Services / Manufacturing Science (TS/MS) is a role encompasses technical leadership and advisory roles in all aspects of sterility assurance of parenteral products, including but not limited to formulation, container closure, delivery systems, processing and manufacturing environment. The Sterility Assurance Steward develops and implements a technical agenda with three primary objectives: (1) reliable, compliant manufacturing of the drug product; (2) improvement of the process control strategy, continuous optimization, development and the innovation of technologies; (3) continual deepening of the scientific understanding of sterility assurance. The technical agenda exists throughout the entire product, process and facility lifecycle. A key attribute of this position includes assessment of existing strategies to identify areas for continuous improvement and development of new strategies for sterility assurance programs, including Contamination Control Strategy, Aseptic Process Simulation, Filter Validation, Container Closure Validation, Leaks and Glove Management, Environmental Monitoring, Facility Disinfection, Gowning and Hygiene, and Sterility Assurance Risk Management programs. At the Steward level, the scientist provides leadership and influence across the Parenteral Network. The scope of the role includes syringe filling and device assembly & packaging operations for commercially manufactured products targeted for transfer to the RTP site. Key Objectives / Deliverables: Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. Use sterility assurance risk management to evaluate existing and proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination. Lead and / or participate in complex projects associated with sterility assurance programs. Lead and / or assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.) Lead major deviations for root cause analysis related to sterility assurance programs. Remain abreast of external regulatory requirements associated with sterility assurance programs. Influence revision to corporate guidance associated with sterility assurance programs. Identify and implement continuous improvement for sterility assurance programs. Provide design input related to new processes (e.g., facilities, equipment, etc.) for RTP. Represents and defends the site's sterility assurance programs during internal audits and external regulatory inspections. Assists with writing of regulatory submissions for sterility assurance programs. Create, review, approve and provide sterility assurance training for new hires and personnel from other sites. Provide technical mentorship to a less senior scientists within the TS/MS organization. Provide technical mentorship to a less senior cross-functional personnel within RTP. Provide technical consultation across the Parenteral Network. Minimum Requirements: BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline Minimum 10 years' experience in the biopharmaceutical industry Additional Preferences: Masters Degree in Microbiology, Biology or related scientific field (or equivalent work experience) preferred Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.) In depth knowledge of risk management and the understanding / ability to use risk assessment tools Ability to analyze complex data and solve problems Strong technical writing and presentation skills Teamwork / interpersonal skills ability to effectively influence Knowledge of microbiology and sterility assurance Other Information: Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required. Position will be based out of RTP site with ability to travel to Indianapolis and other global Lilly sites as required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Banquet Chef - Sedona, AZ Resort $50,000 - $55,000 Have you ever dreamed of working in the heart of Sedona, AZ, where natural beauty meets luxury? Imagine a place where the rugged desert landscape creates a stunning backdrop for an award-winning resort. That's the setting you'll find yourself in as the Banquet Chef at this high-end establishment. Our ideal candidate has experience in the hospitality industry, preferably with resort experience. As the Banquet Chef, you will be instrumental in creating memorable dining experiences for our guests. Located in Sedona, AZ, this role offers the chance to work in one of the most beautiful locations in the United States. As a Banquet Chef, your role involves collaborating with our Executive Chef to deliver exceptional food service across our property, all the while operating within our set budget. Here's what you'll be doing: You'll be at the helm of coordinating all hot and cold banquet foods, working closely with the Executive Chef to ensure our quality standards are met. Your keen eye for quality ensures that our banquet foods are the best available. You'll be attending all daily Banquet Event Order (BEO) meetings, communicating any changes in guarantees and food products to the Executive Chef. As a mentor, you'll be shaping the future of culinary arts by coaching and training aspiring Chefs. You'll also have the opportunity to develop your leadership skills at one of the country's top-rated resorts. You'll assist in maintaining an adequate supply of all food items used at the property, planning one or two days ahead of operations for timely product delivery. You'll be in charge of all banquet food operations, ensuring quality and quantity meet our standards. This involves maintaining a strong relationship with Banquet Managers and the rest of the staff. Your skills in cost control, payroll, and menu planning will be put to good use, working alongside the Executive Chef. Lastly, you'll be communicating with the Executive Steward on all banquet equipment needed, ensuring necessary items are in-house a week ahead. What you bring to the table: An associate degree in culinary arts or equivalent apprenticeship. Excellent communication skills. 3 - 5 years of progressive culinary experience in BOH operations. Strong organizational, communication, and motivational/mentorship skills. Proficiency in Microsoft Office (Word and Excel). Ability to stand, walk, use hands to finger, handle, feel, reach with hands and arms, talk, hear, taste, and smell. ServeSafe Sanitation Management certification. Join us and help shape the future of hospitality! Send your resume to Danielle Salerno As part of our typical recruiting process, from time to time, we may contact you regarding positions that we feel are a good fit for you or engage with you during the recruiting process via SMS text message. Message and data rates may apply, depending on your mobile phone service plan. At any time, you can get more help by replying HELP to these texts, or you can opt-out completely by replying STOP. Our Terms of Service are available at and our Privacy Policy can be found at . By clicking to submit your application of interest, we, as Gecko Hospitality, have your consent to communicate with you via SMS text message moving forward.
May 17, 2024
Full time
Banquet Chef - Sedona, AZ Resort $50,000 - $55,000 Have you ever dreamed of working in the heart of Sedona, AZ, where natural beauty meets luxury? Imagine a place where the rugged desert landscape creates a stunning backdrop for an award-winning resort. That's the setting you'll find yourself in as the Banquet Chef at this high-end establishment. Our ideal candidate has experience in the hospitality industry, preferably with resort experience. As the Banquet Chef, you will be instrumental in creating memorable dining experiences for our guests. Located in Sedona, AZ, this role offers the chance to work in one of the most beautiful locations in the United States. As a Banquet Chef, your role involves collaborating with our Executive Chef to deliver exceptional food service across our property, all the while operating within our set budget. Here's what you'll be doing: You'll be at the helm of coordinating all hot and cold banquet foods, working closely with the Executive Chef to ensure our quality standards are met. Your keen eye for quality ensures that our banquet foods are the best available. You'll be attending all daily Banquet Event Order (BEO) meetings, communicating any changes in guarantees and food products to the Executive Chef. As a mentor, you'll be shaping the future of culinary arts by coaching and training aspiring Chefs. You'll also have the opportunity to develop your leadership skills at one of the country's top-rated resorts. You'll assist in maintaining an adequate supply of all food items used at the property, planning one or two days ahead of operations for timely product delivery. You'll be in charge of all banquet food operations, ensuring quality and quantity meet our standards. This involves maintaining a strong relationship with Banquet Managers and the rest of the staff. Your skills in cost control, payroll, and menu planning will be put to good use, working alongside the Executive Chef. Lastly, you'll be communicating with the Executive Steward on all banquet equipment needed, ensuring necessary items are in-house a week ahead. What you bring to the table: An associate degree in culinary arts or equivalent apprenticeship. Excellent communication skills. 3 - 5 years of progressive culinary experience in BOH operations. Strong organizational, communication, and motivational/mentorship skills. Proficiency in Microsoft Office (Word and Excel). Ability to stand, walk, use hands to finger, handle, feel, reach with hands and arms, talk, hear, taste, and smell. ServeSafe Sanitation Management certification. Join us and help shape the future of hospitality! Send your resume to Danielle Salerno As part of our typical recruiting process, from time to time, we may contact you regarding positions that we feel are a good fit for you or engage with you during the recruiting process via SMS text message. Message and data rates may apply, depending on your mobile phone service plan. At any time, you can get more help by replying HELP to these texts, or you can opt-out completely by replying STOP. Our Terms of Service are available at and our Privacy Policy can be found at . By clicking to submit your application of interest, we, as Gecko Hospitality, have your consent to communicate with you via SMS text message moving forward.
Employment Type: Full time Shift: Day Shift Description: POSITION PURPOSE Under the general direction of the General Manager, Food & Nutrition Services, the Executive Chef is responsible for the oversight and day-to-day culinary operations of the Regional Health Ministry's (RHM) Food & Nutrition Services (FANS) Department with a Total Managed Volume typically ranging from $500,000 to $2,000,000. The Executive Chef is responsible for successfully coordinating and directing all culinary functions, quality control/improvement and culinary personnel within the department as assigned and Helps develop and maintain a culinary integrity program in a single campus environment. Trains and develops existing kitchen staff and develops and cultivates further talent to drive excellence through staff training and engagement. The Executive Chef leads by demonstration through proper cooking techniques and possesses a working knowledge of regulatory and food safety/sanitation practices and principles based on HAACP, Health Department, Joint Commission and THS standards. The Executive Chef coordinates the day-to-day food production and is responsible for the quality, preparation and presentation of all menu items while maintaining a high level of food quality utilizing THS standards and systems. The Executive Chef also interacts, engages and coordinates efforts with clinical dietitians to ensure optimal patient care as well as co-develop and promote wellness, educational and community initiatives. Under the direction of the General Manager, FANS, works collaboratively with all levels of FANS leadership and management team disciplines at RHMs and within the region. Develops and implements plans and implementation processes that support Trinity Health and RHM FANS goals, objectives, strategies, policies, and procedures. Ensures cost reduction targets and productivity improvement objectives are met, while cultivating service/product quality and customer satisfaction. Ensures the General Manager is kept abreast of issues or problems impacting program efficiencies and effectiveness. Attracts, develops and trains talent to ensure program quality, sustainability, long-term growth, and development. The Executive Chef leads by exemplifying the mission, vision and values of Trinity Health and the Regional Health Ministry. ESSENTIAL FUNCTIONS Knows, understands, incorporates, and demonstrates the Trinity Health Mission, Vision, and Values in behaviors, practices, supports and endorses senior leadership decisions, goals, objectives, and strategies. Oversees the day-to-day management of the culinary and sanitation activities for the FANS department and ensures program service support objectives are met. Provides a work environment that fosters positive energy, creativity, and teamwork among associates across all functional areas. Provides operational and technical support to RHM FANS management stakeholders in support of the overall management of FANS programs. Develops, implements and coordinates within the RHM: Implementation of core program systems (Menus, Food Formularies, Cleaning Practices, auditing tools, competencies, etc.) Participates in monthly budget reviews with the Regional Manager and RHM stakeholders to identify budget variances; and prepares related reports for senior management review. Keeps the General Manager informed of issues affecting program costs, service capabilities, effectiveness and efficiencies, as well as issues noted during Performance Improvement audits in areas of responsibility. Presents findings and recommendations for improvement to the General Manager. Meets with direct reports and support staff, as required, to review overall culinary operations goals/objectives, to address shortfalls and open issues and to encourage open dialogue for suggested process improvements. Outlines expectations, accountabilities, and measurables used in determining success. Develops and administers Program Quality Evaluations and reviews Patient and Customer Satisfaction Survey scores for discrepancies and overall customer satisfaction for FANS. Prepares Performance Improvement Plans (PIP) where necessary to resolve customer satisfaction issues and address program quality deficiencies in the culinary area(s). Interviews, hires, trains, appraises, counsels, and supervises staff; handles disciplinary actions. Reviews and approves expense reports and holds direct reports accountable to Trinity Health and THS policies and procedures. Reviews hiring justifications to ensure financial cost saving merit. Ensures timely completion of annual performance appraisals; addresses associate problems and issues related to their work or environment. Fosters the development of diverse teams at all levels as appropriate and outlines annual skills development, career growth opportunities and improvement objectives with direct reports. Establishes and monitors progress on objectives and takes the necessary actions to resolve and prevent recurring issues. Provides the necessary leadership and oversight in cases where disciplinary action or termination is warranted. Manages multiple projects and tasks in a fast paced environment and possesses the ability to adapt to change. Demonstrates the ability to develop a project plan for major projects with milestones to determine schedule of deliverables to advance project outcomes. Participates in Trinity Health FANS regional Advisory councils to develop best in class programs and identifying best practices; driving change to positively affect operational, financial, and service performance at the RHM. Maintains a working knowledge of applicable Federal, State and local laws/regulations; the Trinity Health Integrity and Compliance Program and Code of Conduct; as well as other policies and procedures in order to ensure adherence in a manner that reflects honest, ethical and professional behavior. Ensures all aspects and standards for departmental operations including but not limited to all culinary functions and standards, Patient/Retail Production and Catering and Retail operations as assigned are adhered to. Leads and ensures that all areas function in a compliant, optimal and efficient manner that ensures patient and customer satisfaction Ensures the existence of effective quality improvement programs within the department, as assigned, inclusive of the food borne illness, safety and infection control aspects in the appropriately assigned areas of the department. Ensures all cash handling policies are followed appropriately as assigned and that all cash is accounted for. Ensures that all menus are reviewed annually (Patient, Retail, etc.) and adjusted according to patient/customer preference. Works with assigned clinical nutrition staff to ensure that Nutrient Analysis for all menus are accurate and updated as needed. Ensures that all catered functions are approved, planned and executed per policy in a timely fashion with a customer centered focus. Ensures safe conditions and procedures are followed at all times to minimize/eliminate workman's compensation claims and create a safe working environment for all Food & Nutrition colleagues. Displays the ability to plan and direct food production personnel regarding type and quantity of food to be prepared and any special techniques to be employed for modified diets. Ensures that all menu items follow a THS approved recipe and that all recipes are accessible to culinary staff. Maintains accurate and appropriate records as required. Demonstrates a cost-conscious attitude to time usage and consistently makes the best use of time. May handle additional duties and responsibilities as needed or assigned. MINIMUM QUALIFICATIONS Completion of an accredited culinary institution program or equivalent degree and a minimum of three to five years progressive experience in the general culinary or healthcare foodservice management field or an equivalent combination of education and work experience. Ability to work effectively in a diverse, collaborative, and team oriented culture. Ability to develop methodologies for collecting and analyzing relevant data; to audit program processes; monitor quality; identify, problems and their root causes, and make recommendations for improvement. Excellent leadership, analytical, organizational, planning, delegation, coaching, communication (verbal, written and interpersonal), and computer (MS Word, Excel, Outlook, PowerPoint) skills; with a continuous improvement mindset and ability to challenge conventional thinking at all levels of the organization. A personal presence characterized by a sense of honesty, integrity, and caring with the ability to inspire and motivate others to promote the philosophy, mission, vision, goals, and values of Trinity Health. Ability to be a self-starter and independent worker able to manage multiple conflicting priorities and demands. Ability to delegate responsibilities effectively and provide regular follow up to ensure objectives is met. PHYSICAL / MENTAL REQUIREMENTS AND WORKING CONDITIONS Works in a well-lighted, well-ventilated area. Occasionally exposed to normal food service conditions such as noise, heat and humidity. TRINITY HOSPITALITY SERVICES MISSION STATEMENT In the spirit of our guiding behaviors and as stewards of Trinity Health, our pledge is to deliver culinary, nutritional and hospitality excellence in a compassionate and innovative manner to all we serve across our ministry. . click apply for full job details
May 16, 2024
Full time
Employment Type: Full time Shift: Day Shift Description: POSITION PURPOSE Under the general direction of the General Manager, Food & Nutrition Services, the Executive Chef is responsible for the oversight and day-to-day culinary operations of the Regional Health Ministry's (RHM) Food & Nutrition Services (FANS) Department with a Total Managed Volume typically ranging from $500,000 to $2,000,000. The Executive Chef is responsible for successfully coordinating and directing all culinary functions, quality control/improvement and culinary personnel within the department as assigned and Helps develop and maintain a culinary integrity program in a single campus environment. Trains and develops existing kitchen staff and develops and cultivates further talent to drive excellence through staff training and engagement. The Executive Chef leads by demonstration through proper cooking techniques and possesses a working knowledge of regulatory and food safety/sanitation practices and principles based on HAACP, Health Department, Joint Commission and THS standards. The Executive Chef coordinates the day-to-day food production and is responsible for the quality, preparation and presentation of all menu items while maintaining a high level of food quality utilizing THS standards and systems. The Executive Chef also interacts, engages and coordinates efforts with clinical dietitians to ensure optimal patient care as well as co-develop and promote wellness, educational and community initiatives. Under the direction of the General Manager, FANS, works collaboratively with all levels of FANS leadership and management team disciplines at RHMs and within the region. Develops and implements plans and implementation processes that support Trinity Health and RHM FANS goals, objectives, strategies, policies, and procedures. Ensures cost reduction targets and productivity improvement objectives are met, while cultivating service/product quality and customer satisfaction. Ensures the General Manager is kept abreast of issues or problems impacting program efficiencies and effectiveness. Attracts, develops and trains talent to ensure program quality, sustainability, long-term growth, and development. The Executive Chef leads by exemplifying the mission, vision and values of Trinity Health and the Regional Health Ministry. ESSENTIAL FUNCTIONS Knows, understands, incorporates, and demonstrates the Trinity Health Mission, Vision, and Values in behaviors, practices, supports and endorses senior leadership decisions, goals, objectives, and strategies. Oversees the day-to-day management of the culinary and sanitation activities for the FANS department and ensures program service support objectives are met. Provides a work environment that fosters positive energy, creativity, and teamwork among associates across all functional areas. Provides operational and technical support to RHM FANS management stakeholders in support of the overall management of FANS programs. Develops, implements and coordinates within the RHM: Implementation of core program systems (Menus, Food Formularies, Cleaning Practices, auditing tools, competencies, etc.) Participates in monthly budget reviews with the Regional Manager and RHM stakeholders to identify budget variances; and prepares related reports for senior management review. Keeps the General Manager informed of issues affecting program costs, service capabilities, effectiveness and efficiencies, as well as issues noted during Performance Improvement audits in areas of responsibility. Presents findings and recommendations for improvement to the General Manager. Meets with direct reports and support staff, as required, to review overall culinary operations goals/objectives, to address shortfalls and open issues and to encourage open dialogue for suggested process improvements. Outlines expectations, accountabilities, and measurables used in determining success. Develops and administers Program Quality Evaluations and reviews Patient and Customer Satisfaction Survey scores for discrepancies and overall customer satisfaction for FANS. Prepares Performance Improvement Plans (PIP) where necessary to resolve customer satisfaction issues and address program quality deficiencies in the culinary area(s). Interviews, hires, trains, appraises, counsels, and supervises staff; handles disciplinary actions. Reviews and approves expense reports and holds direct reports accountable to Trinity Health and THS policies and procedures. Reviews hiring justifications to ensure financial cost saving merit. Ensures timely completion of annual performance appraisals; addresses associate problems and issues related to their work or environment. Fosters the development of diverse teams at all levels as appropriate and outlines annual skills development, career growth opportunities and improvement objectives with direct reports. Establishes and monitors progress on objectives and takes the necessary actions to resolve and prevent recurring issues. Provides the necessary leadership and oversight in cases where disciplinary action or termination is warranted. Manages multiple projects and tasks in a fast paced environment and possesses the ability to adapt to change. Demonstrates the ability to develop a project plan for major projects with milestones to determine schedule of deliverables to advance project outcomes. Participates in Trinity Health FANS regional Advisory councils to develop best in class programs and identifying best practices; driving change to positively affect operational, financial, and service performance at the RHM. Maintains a working knowledge of applicable Federal, State and local laws/regulations; the Trinity Health Integrity and Compliance Program and Code of Conduct; as well as other policies and procedures in order to ensure adherence in a manner that reflects honest, ethical and professional behavior. Ensures all aspects and standards for departmental operations including but not limited to all culinary functions and standards, Patient/Retail Production and Catering and Retail operations as assigned are adhered to. Leads and ensures that all areas function in a compliant, optimal and efficient manner that ensures patient and customer satisfaction Ensures the existence of effective quality improvement programs within the department, as assigned, inclusive of the food borne illness, safety and infection control aspects in the appropriately assigned areas of the department. Ensures all cash handling policies are followed appropriately as assigned and that all cash is accounted for. Ensures that all menus are reviewed annually (Patient, Retail, etc.) and adjusted according to patient/customer preference. Works with assigned clinical nutrition staff to ensure that Nutrient Analysis for all menus are accurate and updated as needed. Ensures that all catered functions are approved, planned and executed per policy in a timely fashion with a customer centered focus. Ensures safe conditions and procedures are followed at all times to minimize/eliminate workman's compensation claims and create a safe working environment for all Food & Nutrition colleagues. Displays the ability to plan and direct food production personnel regarding type and quantity of food to be prepared and any special techniques to be employed for modified diets. Ensures that all menu items follow a THS approved recipe and that all recipes are accessible to culinary staff. Maintains accurate and appropriate records as required. Demonstrates a cost-conscious attitude to time usage and consistently makes the best use of time. May handle additional duties and responsibilities as needed or assigned. MINIMUM QUALIFICATIONS Completion of an accredited culinary institution program or equivalent degree and a minimum of three to five years progressive experience in the general culinary or healthcare foodservice management field or an equivalent combination of education and work experience. Ability to work effectively in a diverse, collaborative, and team oriented culture. Ability to develop methodologies for collecting and analyzing relevant data; to audit program processes; monitor quality; identify, problems and their root causes, and make recommendations for improvement. Excellent leadership, analytical, organizational, planning, delegation, coaching, communication (verbal, written and interpersonal), and computer (MS Word, Excel, Outlook, PowerPoint) skills; with a continuous improvement mindset and ability to challenge conventional thinking at all levels of the organization. A personal presence characterized by a sense of honesty, integrity, and caring with the ability to inspire and motivate others to promote the philosophy, mission, vision, goals, and values of Trinity Health. Ability to be a self-starter and independent worker able to manage multiple conflicting priorities and demands. Ability to delegate responsibilities effectively and provide regular follow up to ensure objectives is met. PHYSICAL / MENTAL REQUIREMENTS AND WORKING CONDITIONS Works in a well-lighted, well-ventilated area. Occasionally exposed to normal food service conditions such as noise, heat and humidity. TRINITY HOSPITALITY SERVICES MISSION STATEMENT In the spirit of our guiding behaviors and as stewards of Trinity Health, our pledge is to deliver culinary, nutritional and hospitality excellence in a compassionate and innovative manner to all we serve across our ministry. . click apply for full job details
Employment Type: Full time Shift: Day Shift Description: POSITION PURPOSE Under the general direction of the General Manager, Food & Nutrition Services, the Executive Chef is responsible for the oversight and day-to-day culinary operations of the Regional Health Ministry's (RHM) Food & Nutrition Services (FANS) Department with a Total Managed Volume typically ranging from $500,000 to $2,000,000. The Executive Chef is responsible for successfully coordinating and directing all culinary functions, quality control/improvement and culinary personnel within the department as assigned and Helps develop and maintain a culinary integrity program in a single campus environment. Trains and develops existing kitchen staff and develops and cultivates further talent to drive excellence through staff training and engagement. The Executive Chef leads by demonstration through proper cooking techniques and possesses a working knowledge of regulatory and food safety/sanitation practices and principles based on HAACP, Health Department, Joint Commission and THS standards. The Executive Chef coordinates the day-to-day food production and is responsible for the quality, preparation and presentation of all menu items while maintaining a high level of food quality utilizing THS standards and systems. The Executive Chef also interacts, engages and coordinates efforts with clinical dietitians to ensure optimal patient care as well as co-develop and promote wellness, educational and community initiatives. Under the direction of the General Manager, FANS, works collaboratively with all levels of FANS leadership and management team disciplines at RHMs and within the region. Develops and implements plans and implementation processes that support Trinity Health and RHM FANS goals, objectives, strategies, policies, and procedures. Ensures cost reduction targets and productivity improvement objectives are met, while cultivating service/product quality and customer satisfaction. Ensures the General Manager is kept abreast of issues or problems impacting program efficiencies and effectiveness. Attracts, develops and trains talent to ensure program quality, sustainability, long-term growth, and development. The Executive Chef leads by exemplifying the mission, vision and values of Trinity Health and the Regional Health Ministry. ESSENTIAL FUNCTIONS Knows, understands, incorporates, and demonstrates the Trinity Health Mission, Vision, and Values in behaviors, practices, supports and endorses senior leadership decisions, goals, objectives, and strategies. Oversees the day-to-day management of the culinary and sanitation activities for the FANS department and ensures program service support objectives are met. Provides a work environment that fosters positive energy, creativity, and teamwork among associates across all functional areas. Provides operational and technical support to RHM FANS management stakeholders in support of the overall management of FANS programs. Develops, implements and coordinates within the RHM: Implementation of core program systems (Menus, Food Formularies, Cleaning Practices, auditing tools, competencies, etc.) Participates in monthly budget reviews with the Regional Manager and RHM stakeholders to identify budget variances; and prepares related reports for senior management review. Keeps the General Manager informed of issues affecting program costs, service capabilities, effectiveness and efficiencies, as well as issues noted during Performance Improvement audits in areas of responsibility. Presents findings and recommendations for improvement to the General Manager. Meets with direct reports and support staff, as required, to review overall culinary operations goals/objectives, to address shortfalls and open issues and to encourage open dialogue for suggested process improvements. Outlines expectations, accountabilities, and measurables used in determining success. Develops and administers Program Quality Evaluations and reviews Patient and Customer Satisfaction Survey scores for discrepancies and overall customer satisfaction for FANS. Prepares Performance Improvement Plans (PIP) where necessary to resolve customer satisfaction issues and address program quality deficiencies in the culinary area(s). Interviews, hires, trains, appraises, counsels, and supervises staff; handles disciplinary actions. Reviews and approves expense reports and holds direct reports accountable to Trinity Health and THS policies and procedures. Reviews hiring justifications to ensure financial cost saving merit. Ensures timely completion of annual performance appraisals; addresses associate problems and issues related to their work or environment. Fosters the development of diverse teams at all levels as appropriate and outlines annual skills development, career growth opportunities and improvement objectives with direct reports. Establishes and monitors progress on objectives and takes the necessary actions to resolve and prevent recurring issues. Provides the necessary leadership and oversight in cases where disciplinary action or termination is warranted. Manages multiple projects and tasks in a fast paced environment and possesses the ability to adapt to change. Demonstrates the ability to develop a project plan for major projects with milestones to determine schedule of deliverables to advance project outcomes. Participates in Trinity Health FANS regional Advisory councils to develop best in class programs and identifying best practices; driving change to positively affect operational, financial, and service performance at the RHM. Maintains a working knowledge of applicable Federal, State and local laws/regulations; the Trinity Health Integrity and Compliance Program and Code of Conduct; as well as other policies and procedures in order to ensure adherence in a manner that reflects honest, ethical and professional behavior. Ensures all aspects and standards for departmental operations including but not limited to all culinary functions and standards, Patient/Retail Production and Catering and Retail operations as assigned are adhered to. Leads and ensures that all areas function in a compliant, optimal and efficient manner that ensures patient and customer satisfaction Ensures the existence of effective quality improvement programs within the department, as assigned, inclusive of the food borne illness, safety and infection control aspects in the appropriately assigned areas of the department. Ensures all cash handling policies are followed appropriately as assigned and that all cash is accounted for. Ensures that all menus are reviewed annually (Patient, Retail, etc.) and adjusted according to patient/customer preference. Works with assigned clinical nutrition staff to ensure that Nutrient Analysis for all menus are accurate and updated as needed. Ensures that all catered functions are approved, planned and executed per policy in a timely fashion with a customer centered focus. Ensures safe conditions and procedures are followed at all times to minimize/eliminate workman's compensation claims and create a safe working environment for all Food & Nutrition colleagues. Displays the ability to plan and direct food production personnel regarding type and quantity of food to be prepared and any special techniques to be employed for modified diets. Ensures that all menu items follow a THS approved recipe and that all recipes are accessible to culinary staff. Maintains accurate and appropriate records as required. Demonstrates a cost-conscious attitude to time usage and consistently makes the best use of time. May handle additional duties and responsibilities as needed or assigned. MINIMUM QUALIFICATIONS Completion of an accredited culinary institution program or equivalent degree and a minimum of three to five years progressive experience in the general culinary or healthcare foodservice management field or an equivalent combination of education and work experience. Ability to work effectively in a diverse, collaborative, and team oriented culture. Ability to develop methodologies for collecting and analyzing relevant data; to audit program processes; monitor quality; identify, problems and their root causes, and make recommendations for improvement. Excellent leadership, analytical, organizational, planning, delegation, coaching, communication (verbal, written and interpersonal), and computer (MS Word, Excel, Outlook, PowerPoint) skills; with a continuous improvement mindset and ability to challenge conventional thinking at all levels of the organization. A personal presence characterized by a sense of honesty, integrity, and caring with the ability to inspire and motivate others to promote the philosophy, mission, vision, goals, and values of Trinity Health. Ability to be a self-starter and independent worker able to manage multiple conflicting priorities and demands. Ability to delegate responsibilities effectively and provide regular follow up to ensure objectives is met. PHYSICAL / MENTAL REQUIREMENTS AND WORKING CONDITIONS Works in a well-lighted, well-ventilated area. Occasionally exposed to normal food service conditions such as noise, heat and humidity. TRINITY HOSPITALITY SERVICES MISSION STATEMENT In the spirit of our guiding behaviors and as stewards of Trinity Health, our pledge is to deliver culinary, nutritional and hospitality excellence in a compassionate and innovative manner to all we serve across our ministry. . click apply for full job details
May 16, 2024
Full time
Employment Type: Full time Shift: Day Shift Description: POSITION PURPOSE Under the general direction of the General Manager, Food & Nutrition Services, the Executive Chef is responsible for the oversight and day-to-day culinary operations of the Regional Health Ministry's (RHM) Food & Nutrition Services (FANS) Department with a Total Managed Volume typically ranging from $500,000 to $2,000,000. The Executive Chef is responsible for successfully coordinating and directing all culinary functions, quality control/improvement and culinary personnel within the department as assigned and Helps develop and maintain a culinary integrity program in a single campus environment. Trains and develops existing kitchen staff and develops and cultivates further talent to drive excellence through staff training and engagement. The Executive Chef leads by demonstration through proper cooking techniques and possesses a working knowledge of regulatory and food safety/sanitation practices and principles based on HAACP, Health Department, Joint Commission and THS standards. The Executive Chef coordinates the day-to-day food production and is responsible for the quality, preparation and presentation of all menu items while maintaining a high level of food quality utilizing THS standards and systems. The Executive Chef also interacts, engages and coordinates efforts with clinical dietitians to ensure optimal patient care as well as co-develop and promote wellness, educational and community initiatives. Under the direction of the General Manager, FANS, works collaboratively with all levels of FANS leadership and management team disciplines at RHMs and within the region. Develops and implements plans and implementation processes that support Trinity Health and RHM FANS goals, objectives, strategies, policies, and procedures. Ensures cost reduction targets and productivity improvement objectives are met, while cultivating service/product quality and customer satisfaction. Ensures the General Manager is kept abreast of issues or problems impacting program efficiencies and effectiveness. Attracts, develops and trains talent to ensure program quality, sustainability, long-term growth, and development. The Executive Chef leads by exemplifying the mission, vision and values of Trinity Health and the Regional Health Ministry. ESSENTIAL FUNCTIONS Knows, understands, incorporates, and demonstrates the Trinity Health Mission, Vision, and Values in behaviors, practices, supports and endorses senior leadership decisions, goals, objectives, and strategies. Oversees the day-to-day management of the culinary and sanitation activities for the FANS department and ensures program service support objectives are met. Provides a work environment that fosters positive energy, creativity, and teamwork among associates across all functional areas. Provides operational and technical support to RHM FANS management stakeholders in support of the overall management of FANS programs. Develops, implements and coordinates within the RHM: Implementation of core program systems (Menus, Food Formularies, Cleaning Practices, auditing tools, competencies, etc.) Participates in monthly budget reviews with the Regional Manager and RHM stakeholders to identify budget variances; and prepares related reports for senior management review. Keeps the General Manager informed of issues affecting program costs, service capabilities, effectiveness and efficiencies, as well as issues noted during Performance Improvement audits in areas of responsibility. Presents findings and recommendations for improvement to the General Manager. Meets with direct reports and support staff, as required, to review overall culinary operations goals/objectives, to address shortfalls and open issues and to encourage open dialogue for suggested process improvements. Outlines expectations, accountabilities, and measurables used in determining success. Develops and administers Program Quality Evaluations and reviews Patient and Customer Satisfaction Survey scores for discrepancies and overall customer satisfaction for FANS. Prepares Performance Improvement Plans (PIP) where necessary to resolve customer satisfaction issues and address program quality deficiencies in the culinary area(s). Interviews, hires, trains, appraises, counsels, and supervises staff; handles disciplinary actions. Reviews and approves expense reports and holds direct reports accountable to Trinity Health and THS policies and procedures. Reviews hiring justifications to ensure financial cost saving merit. Ensures timely completion of annual performance appraisals; addresses associate problems and issues related to their work or environment. Fosters the development of diverse teams at all levels as appropriate and outlines annual skills development, career growth opportunities and improvement objectives with direct reports. Establishes and monitors progress on objectives and takes the necessary actions to resolve and prevent recurring issues. Provides the necessary leadership and oversight in cases where disciplinary action or termination is warranted. Manages multiple projects and tasks in a fast paced environment and possesses the ability to adapt to change. Demonstrates the ability to develop a project plan for major projects with milestones to determine schedule of deliverables to advance project outcomes. Participates in Trinity Health FANS regional Advisory councils to develop best in class programs and identifying best practices; driving change to positively affect operational, financial, and service performance at the RHM. Maintains a working knowledge of applicable Federal, State and local laws/regulations; the Trinity Health Integrity and Compliance Program and Code of Conduct; as well as other policies and procedures in order to ensure adherence in a manner that reflects honest, ethical and professional behavior. Ensures all aspects and standards for departmental operations including but not limited to all culinary functions and standards, Patient/Retail Production and Catering and Retail operations as assigned are adhered to. Leads and ensures that all areas function in a compliant, optimal and efficient manner that ensures patient and customer satisfaction Ensures the existence of effective quality improvement programs within the department, as assigned, inclusive of the food borne illness, safety and infection control aspects in the appropriately assigned areas of the department. Ensures all cash handling policies are followed appropriately as assigned and that all cash is accounted for. Ensures that all menus are reviewed annually (Patient, Retail, etc.) and adjusted according to patient/customer preference. Works with assigned clinical nutrition staff to ensure that Nutrient Analysis for all menus are accurate and updated as needed. Ensures that all catered functions are approved, planned and executed per policy in a timely fashion with a customer centered focus. Ensures safe conditions and procedures are followed at all times to minimize/eliminate workman's compensation claims and create a safe working environment for all Food & Nutrition colleagues. Displays the ability to plan and direct food production personnel regarding type and quantity of food to be prepared and any special techniques to be employed for modified diets. Ensures that all menu items follow a THS approved recipe and that all recipes are accessible to culinary staff. Maintains accurate and appropriate records as required. Demonstrates a cost-conscious attitude to time usage and consistently makes the best use of time. May handle additional duties and responsibilities as needed or assigned. MINIMUM QUALIFICATIONS Completion of an accredited culinary institution program or equivalent degree and a minimum of three to five years progressive experience in the general culinary or healthcare foodservice management field or an equivalent combination of education and work experience. Ability to work effectively in a diverse, collaborative, and team oriented culture. Ability to develop methodologies for collecting and analyzing relevant data; to audit program processes; monitor quality; identify, problems and their root causes, and make recommendations for improvement. Excellent leadership, analytical, organizational, planning, delegation, coaching, communication (verbal, written and interpersonal), and computer (MS Word, Excel, Outlook, PowerPoint) skills; with a continuous improvement mindset and ability to challenge conventional thinking at all levels of the organization. A personal presence characterized by a sense of honesty, integrity, and caring with the ability to inspire and motivate others to promote the philosophy, mission, vision, goals, and values of Trinity Health. Ability to be a self-starter and independent worker able to manage multiple conflicting priorities and demands. Ability to delegate responsibilities effectively and provide regular follow up to ensure objectives is met. PHYSICAL / MENTAL REQUIREMENTS AND WORKING CONDITIONS Works in a well-lighted, well-ventilated area. Occasionally exposed to normal food service conditions such as noise, heat and humidity. TRINITY HOSPITALITY SERVICES MISSION STATEMENT In the spirit of our guiding behaviors and as stewards of Trinity Health, our pledge is to deliver culinary, nutritional and hospitality excellence in a compassionate and innovative manner to all we serve across our ministry. . click apply for full job details
Description SCOPE OF POSITION: Responsible for maintaining and organizing all banquet rooms, hallways, storage and service areas. Ensures banquet event orders are followed so that setup are completed to required specifications and in a timely manner. Responsible for the tear down all events after conclusion. All duties are to be performed in accordance with Tribal, federal, state, local laws, regulations, and ordinances, as well as department and company policies, practices, and procedures. ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of the main duties and responsibilities. However, other duties may be assigned as deemed necessary by management. All duties must be performed in accordance with Tribal, Federal, and other applicable requirements, organizational specific policies, procedures and practices. Reviews all banquet event orders and assignments with the Stewarding Supervisor on duty to ensure accuracy Setups all banquet rooms to the specifications requested per the banquet event order Acts as a food runner or busser as needed; assists banquet and culinary staff as needed Maintains cleanliness of all banquet storage areas, hallways and function rooms on a daily basis Pick up trash and takes to designated areas and washes trash cans when emptied Responsible the cleaning of all banquet equipment and displays including banquet event dishes Able to carry or move items up to 75 pounds Must be able to meet timelines in completion of all banquet set-ups Operates a variety of stewarding equipment (i.e.: shop vacs, steamers, floor scrubbers) Breakdown function areas as scheduled in accordance with departmental procedures Maintains a constant awareness of safety and accident prevention Promotes and maintains the highest level of guest service to all guests while staying alert to their needs Maintains the highest level of confidentiality Responsible for maintaining a consistent, regular attendance record as outlined in the FireKeepers Casino Hotel Attendance Policy Outstanding example of and a credit to FireKeepers Casino Hotel Minimum Requirements MINIMUM REQUIRED QUALIFICATIONS An applicant's education, training and experience must be sufficient to demonstrate that the applicant possesses the ability to successfully perform each of the essential duties and responsibilities satisfactorily. FireKeepers reserves the right to verify the sufficiency of a candidate's education, training and competencies through the interview process, testing and methods. The requirements listed below are generally representative of the education, experience, and skills and/or abilities required to enable one to successfully perform the essential duties and responsibilities: Strong attention to detail skills. GENERAL OR PREFERRED QUALIFICATIONS One year customer service experience in a similar position in the hospitality industry. High School Diploma or GED. LANGUAGE SKILLS Ability to read and interpret documents such as safety rules, operating and maintenance instruction, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. MATHEMATICAL SKILLS Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimal, and work with mathematical such as probability and statistical inference. REASONING ABILITY Ability to define problems, collect data, establish facts, and draw conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. PHYSICAL & ENVIRONMENTAL DEMANDS: The physical demands described here are representative of those that must be met by a Team Member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, a Team Member is regularly required to talk or to hear. The Team Member is also regularly required to stand, walk, sit, and use hands to handle or feel objects, tools or controls. A Team Member is occasionally required to reach with hands and arms, and to sit; climb or balance; and stoop, kneel, crouch or crawl. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus. Work is performed throughout all areas of the facility where the noise level varies from quiet to loud depending upon business. Must be able to work in a smoke filled environment. INDIAN PREFERENCE Indian preference will be applied in the selection of qualified applicants in accordance with the NHBP Indian Preference in Employment Code, which affords employment preferences to NHBP Tribal citizens, parents or spouses of NHBP citizens and other Native Americans. For purposes of this preference, NHBP law defines "Native American" as: (a) an enrolled member of any other federally-recognized Indian tribes; (b) an enrolled member of a Canadian Indian tribe or First Nation; or (c) an enrolled member of the Grand River Band of Ottawa Indians or the Burt Lake Band of Ottawa/Chippewa Indians. FireKeepers Casino Hotel reserves the right to make changes to the above job description as necessary. Category: Food & Beverage
May 13, 2024
Full time
Description SCOPE OF POSITION: Responsible for maintaining and organizing all banquet rooms, hallways, storage and service areas. Ensures banquet event orders are followed so that setup are completed to required specifications and in a timely manner. Responsible for the tear down all events after conclusion. All duties are to be performed in accordance with Tribal, federal, state, local laws, regulations, and ordinances, as well as department and company policies, practices, and procedures. ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of the main duties and responsibilities. However, other duties may be assigned as deemed necessary by management. All duties must be performed in accordance with Tribal, Federal, and other applicable requirements, organizational specific policies, procedures and practices. Reviews all banquet event orders and assignments with the Stewarding Supervisor on duty to ensure accuracy Setups all banquet rooms to the specifications requested per the banquet event order Acts as a food runner or busser as needed; assists banquet and culinary staff as needed Maintains cleanliness of all banquet storage areas, hallways and function rooms on a daily basis Pick up trash and takes to designated areas and washes trash cans when emptied Responsible the cleaning of all banquet equipment and displays including banquet event dishes Able to carry or move items up to 75 pounds Must be able to meet timelines in completion of all banquet set-ups Operates a variety of stewarding equipment (i.e.: shop vacs, steamers, floor scrubbers) Breakdown function areas as scheduled in accordance with departmental procedures Maintains a constant awareness of safety and accident prevention Promotes and maintains the highest level of guest service to all guests while staying alert to their needs Maintains the highest level of confidentiality Responsible for maintaining a consistent, regular attendance record as outlined in the FireKeepers Casino Hotel Attendance Policy Outstanding example of and a credit to FireKeepers Casino Hotel Minimum Requirements MINIMUM REQUIRED QUALIFICATIONS An applicant's education, training and experience must be sufficient to demonstrate that the applicant possesses the ability to successfully perform each of the essential duties and responsibilities satisfactorily. FireKeepers reserves the right to verify the sufficiency of a candidate's education, training and competencies through the interview process, testing and methods. The requirements listed below are generally representative of the education, experience, and skills and/or abilities required to enable one to successfully perform the essential duties and responsibilities: Strong attention to detail skills. GENERAL OR PREFERRED QUALIFICATIONS One year customer service experience in a similar position in the hospitality industry. High School Diploma or GED. LANGUAGE SKILLS Ability to read and interpret documents such as safety rules, operating and maintenance instruction, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. MATHEMATICAL SKILLS Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimal, and work with mathematical such as probability and statistical inference. REASONING ABILITY Ability to define problems, collect data, establish facts, and draw conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. PHYSICAL & ENVIRONMENTAL DEMANDS: The physical demands described here are representative of those that must be met by a Team Member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, a Team Member is regularly required to talk or to hear. The Team Member is also regularly required to stand, walk, sit, and use hands to handle or feel objects, tools or controls. A Team Member is occasionally required to reach with hands and arms, and to sit; climb or balance; and stoop, kneel, crouch or crawl. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus. Work is performed throughout all areas of the facility where the noise level varies from quiet to loud depending upon business. Must be able to work in a smoke filled environment. INDIAN PREFERENCE Indian preference will be applied in the selection of qualified applicants in accordance with the NHBP Indian Preference in Employment Code, which affords employment preferences to NHBP Tribal citizens, parents or spouses of NHBP citizens and other Native Americans. For purposes of this preference, NHBP law defines "Native American" as: (a) an enrolled member of any other federally-recognized Indian tribes; (b) an enrolled member of a Canadian Indian tribe or First Nation; or (c) an enrolled member of the Grand River Band of Ottawa Indians or the Burt Lake Band of Ottawa/Chippewa Indians. FireKeepers Casino Hotel reserves the right to make changes to the above job description as necessary. Category: Food & Beverage
WE PREPARE, INSPIRE, EMPOWER, ENTRUST IN YOU! JOIN OUR DREAM MAKER CULTURE We are committed to invest in our people to develop a happy and prosperous future. We support you every step of the way in your career journey and offer benefits and unique learning and development opportunities that include: Competitive Wages • Medical, Dental, Vision Insurance • Life Insurance • 401K Program • Paid Holidays and Vacation • Outstanding Recognition and Awards Program • Effective Training Programs • Tuition Reimbursement • Complimentary Parking and Meals in Dedicated Employee Restaurant • Preferred Pricing on Food and Beverage, Spa Treatments and Retail Purchases • Management Programs to Progress on Your Career Journey • Health and Wellness Fairs JOB OVERVIEW: Assist Servers retrieving food from the kitchen and providing quality food and beverage service to guests courteously and efficiently. Also assists in the maintenance of the Room Service area and equipment. Stock all wares and equipment needed for service. REPORTS TO: F&B Management WORK ENVIRONMENT: IRD, Kitchen/Stewarding service areas. Job involves working: under variable temperature conditions (or extreme heat or cold). under variable noise levels. outdoors/indoors. around fumes and/or odor hazards. around dust and/or mite hazards. around chemicals. KEY RELATIONSHIPS: Internal: Staff in Room Service, Bar, Kitchen/Stewarding, Engineering, Housekeeping, Front Desk, Sales and Banquet/Catering Department External: Resort guest/visitors and resident guest/visitors. QUALIFICATIONS Essential: Food handling certification. Minimum 18 years of age to serve alcoholic beverages. Fluency in English both verbal and non-verbal. Provide legible communication and directions. Compute basic arithmetic. Ability to: perform job functions with attention to detail, speed and accuracy. prioritize, organize and follow up. be a clear thinker, remaining calm and resolving problems using good judgment. follow directions thoroughly. understand guest's service needs. work cohesively with co-workers as part of a team. work with minimal supervision. maintain confidentiality of guest information and pertinent resort data. Desirable: High school graduate or equivalent vocational training certificate. Previous experience in a similar position. Certification of previous training in alcohol awareness program. Certifications of previous training in sanitation. Certification in CPR. Previous guest relations training. Fluency in a second language, preferably Spanish/other. PHYSICAL ABILITIES Essential: Exert physical effort in transporting pounds. Endure various physical movements throughout the work areas. Reach 18/26 inches/feet. Remain in stationary position for 8 hours throughout work shift. Satisfactorily communicate with guests, management and co-workers to their understanding.
May 01, 2024
Full time
WE PREPARE, INSPIRE, EMPOWER, ENTRUST IN YOU! JOIN OUR DREAM MAKER CULTURE We are committed to invest in our people to develop a happy and prosperous future. We support you every step of the way in your career journey and offer benefits and unique learning and development opportunities that include: Competitive Wages • Medical, Dental, Vision Insurance • Life Insurance • 401K Program • Paid Holidays and Vacation • Outstanding Recognition and Awards Program • Effective Training Programs • Tuition Reimbursement • Complimentary Parking and Meals in Dedicated Employee Restaurant • Preferred Pricing on Food and Beverage, Spa Treatments and Retail Purchases • Management Programs to Progress on Your Career Journey • Health and Wellness Fairs JOB OVERVIEW: Assist Servers retrieving food from the kitchen and providing quality food and beverage service to guests courteously and efficiently. Also assists in the maintenance of the Room Service area and equipment. Stock all wares and equipment needed for service. REPORTS TO: F&B Management WORK ENVIRONMENT: IRD, Kitchen/Stewarding service areas. Job involves working: under variable temperature conditions (or extreme heat or cold). under variable noise levels. outdoors/indoors. around fumes and/or odor hazards. around dust and/or mite hazards. around chemicals. KEY RELATIONSHIPS: Internal: Staff in Room Service, Bar, Kitchen/Stewarding, Engineering, Housekeeping, Front Desk, Sales and Banquet/Catering Department External: Resort guest/visitors and resident guest/visitors. QUALIFICATIONS Essential: Food handling certification. Minimum 18 years of age to serve alcoholic beverages. Fluency in English both verbal and non-verbal. Provide legible communication and directions. Compute basic arithmetic. Ability to: perform job functions with attention to detail, speed and accuracy. prioritize, organize and follow up. be a clear thinker, remaining calm and resolving problems using good judgment. follow directions thoroughly. understand guest's service needs. work cohesively with co-workers as part of a team. work with minimal supervision. maintain confidentiality of guest information and pertinent resort data. Desirable: High school graduate or equivalent vocational training certificate. Previous experience in a similar position. Certification of previous training in alcohol awareness program. Certifications of previous training in sanitation. Certification in CPR. Previous guest relations training. Fluency in a second language, preferably Spanish/other. PHYSICAL ABILITIES Essential: Exert physical effort in transporting pounds. Endure various physical movements throughout the work areas. Reach 18/26 inches/feet. Remain in stationary position for 8 hours throughout work shift. Satisfactorily communicate with guests, management and co-workers to their understanding.