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.
Mar 15, 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. Organization Overview At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges. The Analytical Technical Steward in API (Active Pharmaceutical Ingredient) External Manufacturing Quality Control is a technical position helping to ensure that the analytical testing of products at multiple sites meets both Lilly and external requirements and is executed consistently to predetermined standards. The Analytical Technical Steward reviews data released by contract manufacturers according to API EM Risk Based Oversight Governance to ensure it meets internal integration and data integrity expectations, reviews deviations for trends, reviews and/or releases stability data, and leads resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results. They may perform non-routine lab work in support of this. Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional internal and joint process teams. The Analytical Technical Steward works closely with development counterparts and GQL (Global Quality Laboratories) to ensure robust analytical control strategies are established for molecules they support. Responsibilities: Technical review, interpretation, and release of data including data released from CM (Contract Manufacturers), stability, process validation, and reference standard characterization. Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. Develop investigational testing protocols and perform testing as required. Contribute to APR, tech transfer, and process validation as required. Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners. Participate in internal/external audits as needed. Develop and ensure execution of quality plan projects. Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing. Performs method assessments, with deficiencies and areas for improvement noted within the assessments. Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed. Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in practices). Review of analytical test method packages. Approval of test method protocols. Approval of new test methods or changes or deletions to existing test methods. Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions). Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies. Improve assays in QC. These improvements include variability reduction, method optimization, and new method development. Local and Global Method Change Control Ownership. Oversight of reference standard evaluations per Global Quality Standards. Selection of appropriate packaging materials. Consult in the preparation of the characterization protocol for corporate reference standards. Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards. Participate in the review of the reference standard profile and associated documentation for data integrity. Method transfers to Contract Manufacturers. Oversee transfer of analytical methods for marketed products to CM laboratories or to designated third party QC labs. Monograph review and implementation. Ensures consistent practices between laboratories running the same methods. Effective management of multiple projects. Basic Requirements: Bachelor degree (4 year College) in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy) 3+ years of industry related experience in pharmaceuticals in a GMP lab (especially large molecule, small molecule or peptide) Additional Skills/Preferences: Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, and bioassay. Working LC-MS knowledge strongly preferred. Ability to work in a lab environment, including wearing appropriate PPE and following safety guidelines. Deep understanding of compliance requirements and regulatory expectations. Demonstrated accuracy and proficiency in analytical skills. Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology. Strong oral and written communication skills demonstrated through documentation and presentations. Demonstrated strong interpersonal interaction skills. Ability to work in cross functional teams as well as across networks. Demonstrated analytical skills. Demonstrated experience with method qualification, validation, and transfer. Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs to include small molecules, monoclonal antibodies, synthetic peptides, and E. coli platform large molecules. Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV). Proven ability to support maintenance of Corporate Reference Standards and manage testing and reporting of results from contract manufacturers. Additional Information: Tasks may require repetitive motion and standing for long periods of time Must be able to lift at least 5 liters of liquid May be required to provide 24 hour cell phone coverage (rare) Position will be day shift, but may require some shift to support global operations May require up to approximately 20% of travel overseas, passport 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.
Mar 13, 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. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges. The Analytical Technical Steward in API (Active Pharmaceutical Ingredient) External Manufacturing Quality Control is a technical position helping to ensure that the analytical testing of products at multiple sites meets both Lilly and external requirements and is executed consistently to predetermined standards. The Analytical Technical Steward reviews data released by contract manufacturers according to API EM Risk Based Oversight Governance to ensure it meets internal integration and data integrity expectations, reviews deviations for trends, reviews and/or releases stability data, and leads resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results. They may perform non-routine lab work in support of this. Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional internal and joint process teams. The Analytical Technical Steward works closely with development counterparts and GQL (Global Quality Laboratories) to ensure robust analytical control strategies are established for molecules they support. Responsibilities: Technical review, interpretation, and release of data including data released from CM (Contract Manufacturers), stability, process validation, and reference standard characterization. Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. Develop investigational testing protocols and perform testing as required. Contribute to APR, tech transfer, and process validation as required. Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners. Participate in internal/external audits as needed. Develop and ensure execution of quality plan projects. Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing. Performs method assessments, with deficiencies and areas for improvement noted within the assessments. Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed. Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in practices). Review of analytical test method packages. Approval of test method protocols. Approval of new test methods or changes or deletions to existing test methods. Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions). Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies. Improve assays in QC. These improvements include variability reduction, method optimization, and new method development. Local and Global Method Change Control Ownership. Oversight of reference standard evaluations per Global Quality Standards. Selection of appropriate packaging materials. Consult in the preparation of the characterization protocol for corporate reference standards. Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards. Participate in the review of the reference standard profile and associated documentation for data integrity. Method transfers to Contract Manufacturers. Oversee transfer of analytical methods for marketed products to CM laboratories or to designated third party QC labs. Monograph review and implementation. Ensures consistent practices between laboratories running the same methods. Effective management of multiple projects. Basic Requirements: Bachelor degree (4 year College) in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy) 3+ years of industry related experience in pharmaceuticals in a GMP lab (especially large molecule, small molecule or peptide) Additional Skills/Preferences: Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, and bioassay. Working LC-MS knowledge strongly preferred. Ability to work in a lab environment, including wearing appropriate PPE and following safety guidelines. Deep understanding of compliance requirements and regulatory expectations. Demonstrated accuracy and proficiency in analytical skills. Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology. Strong oral and written communication skills demonstrated through documentation and presentations. Demonstrated strong interpersonal interaction skills. Ability to work in cross functional teams as well as across networks. Demonstrated analytical skills. Demonstrated experience with method qualification, validation, and transfer. Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs to include small molecules, monoclonal antibodies, synthetic peptides, and E. coli platform large molecules. Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV). Proven ability to support maintenance of Corporate Reference Standards and manage testing and reporting of results from contract manufacturers. Additional Information: Tasks may require repetitive motion and standing for long periods of time Must be able to lift at least 5 liters of liquid May be required to provide 24 hour cell phone coverage (rare) Position will be day shift, but may require some shift to support global operations May require up to approximately 20% of travel overseas, passport 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. Organization Overview The Analytical Technical Steward in API (Active Pharmaceutical Ingredient) External Manufacturing Quality Control is a technical position helping to ensure that the analytical testing of products at multiple sites meets both Lilly and external requirements and is executed consistently to predetermined standards. The Analytical Technical Steward reviews data released by contract manufacturers according to API EM Risk Based Oversight Governance to ensure it meets internal integration and data integrity expectations, reviews deviations for trends, reviews and/or releases stability data, and leads resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results. They may perform non-routine lab work in support of this. Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional internal and joint process teams. The Analytical Technical Steward works closely with development counterparts and GQL (Global Quality Laboratories) to ensure robust analytical control strategies are established for molecules they support. Responsibilities: Technical review, interpretation, and release of data including data released from CM (Contract Manufacturers), stability, process validation, and reference standard characterization. Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. Develop investigational testing protocols and perform testing as required. Contribute to APR, tech transfer, and process validation as required. Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners. Participate in internal/external audits as needed. Develop and ensure execution of quality plan projects. Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing. Performs method assessments, with deficiencies and areas for improvement noted within the assessments. Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed. Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in practices). Review of analytical test method packages. Approval of test method protocols. Approval of new test methods or changes or deletions to existing test methods. Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions). Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies. Improve assays in QC. These improvements include variability reduction, method optimization, and new method development. Local and Global Method Change Control Ownership. Oversight of reference standard evaluations per Global Quality Standards. Selection of appropriate packaging materials. Consult in the preparation of the characterization protocol for corporate reference standards. Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards. Participate in the review of the reference standard profile and associated documentation for data integrity. Method transfers to Contract Manufacturers. Oversee transfer of analytical methods for marketed products to CM laboratories or to designated third party QC labs. Monograph review and implementation. Ensures consistent practices between laboratories running the same methods. Effective management of multiple projects. Basic Requirements: Bachelor degree (4 year College) in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy) 5+ years of industry related experience in pharmaceuticals in a GMP lab must have experience with mAbs Additional Skills/Preferences: Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, CE-R, CE-NR, iCief and bioassay. Ability to work in a lab environment, including wearing appropriate PPE and following safety guidelines. Deep understanding of compliance requirements and regulatory expectations. Demonstrated accuracy and proficiency in analytical skills. Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology. Strong oral and written communication skills demonstrated through documentation and presentations. Demonstrated strong interpersonal interaction skills. Ability to work in cross functional teams as well as across networks. Demonstrated analytical skills. Demonstrated experience with method qualification, validation, and transfer. Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs to include small molecules, monoclonal antibodies, synthetic peptides, and E. coli platform large molecules. Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV). Proven ability to support maintenance of Corporate Reference Standards and manage testing and reporting of results from contract manufacturers. Additional Information: Tasks may require repetitive motion and standing for long periods of time Must be able to lift at least 5 liters of liquid May be required to provide 24 hour cell phone coverage (rare) Position will be day shift, but may require some shift to support global operations May require up to approximately 20% of travel overseas, passport 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.
Mar 01, 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 The Analytical Technical Steward in API (Active Pharmaceutical Ingredient) External Manufacturing Quality Control is a technical position helping to ensure that the analytical testing of products at multiple sites meets both Lilly and external requirements and is executed consistently to predetermined standards. The Analytical Technical Steward reviews data released by contract manufacturers according to API EM Risk Based Oversight Governance to ensure it meets internal integration and data integrity expectations, reviews deviations for trends, reviews and/or releases stability data, and leads resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results. They may perform non-routine lab work in support of this. Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional internal and joint process teams. The Analytical Technical Steward works closely with development counterparts and GQL (Global Quality Laboratories) to ensure robust analytical control strategies are established for molecules they support. Responsibilities: Technical review, interpretation, and release of data including data released from CM (Contract Manufacturers), stability, process validation, and reference standard characterization. Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. Develop investigational testing protocols and perform testing as required. Contribute to APR, tech transfer, and process validation as required. Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners. Participate in internal/external audits as needed. Develop and ensure execution of quality plan projects. Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing. Performs method assessments, with deficiencies and areas for improvement noted within the assessments. Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed. Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in practices). Review of analytical test method packages. Approval of test method protocols. Approval of new test methods or changes or deletions to existing test methods. Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions). Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies. Improve assays in QC. These improvements include variability reduction, method optimization, and new method development. Local and Global Method Change Control Ownership. Oversight of reference standard evaluations per Global Quality Standards. Selection of appropriate packaging materials. Consult in the preparation of the characterization protocol for corporate reference standards. Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards. Participate in the review of the reference standard profile and associated documentation for data integrity. Method transfers to Contract Manufacturers. Oversee transfer of analytical methods for marketed products to CM laboratories or to designated third party QC labs. Monograph review and implementation. Ensures consistent practices between laboratories running the same methods. Effective management of multiple projects. Basic Requirements: Bachelor degree (4 year College) in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy) 5+ years of industry related experience in pharmaceuticals in a GMP lab must have experience with mAbs Additional Skills/Preferences: Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, CE-R, CE-NR, iCief and bioassay. Ability to work in a lab environment, including wearing appropriate PPE and following safety guidelines. Deep understanding of compliance requirements and regulatory expectations. Demonstrated accuracy and proficiency in analytical skills. Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology. Strong oral and written communication skills demonstrated through documentation and presentations. Demonstrated strong interpersonal interaction skills. Ability to work in cross functional teams as well as across networks. Demonstrated analytical skills. Demonstrated experience with method qualification, validation, and transfer. Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs to include small molecules, monoclonal antibodies, synthetic peptides, and E. coli platform large molecules. Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV). Proven ability to support maintenance of Corporate Reference Standards and manage testing and reporting of results from contract manufacturers. Additional Information: Tasks may require repetitive motion and standing for long periods of time Must be able to lift at least 5 liters of liquid May be required to provide 24 hour cell phone coverage (rare) Position will be day shift, but may require some shift to support global operations May require up to approximately 20% of travel overseas, passport 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.
Food Safety and Inspection Service
Spring Mills, Pennsylvania
Summary All Consumer Safety Officers may be detailed anywhere inside or outside the Philadelphia District to conduct Food Safety Assessments. Specific Vacancy Information: Spring Mills, PA Consumer Safety Officer (EIAO) SJ-541, GS-0696-11/12 Location: Spring Mills, PA- located in Centre County Responsibilities This position may be filled as a multi-grade career ladder. If position is filled at a developmental grade level, assignments will be of a more limited scope, performed with less independence, and may reflect limited complexity/personal contacts. You may/will: Conduct on site consumer protection assessments to verify the design and proper functioning of a plant's food safety and process control systems. Assess the scientific adequacy of Hazard Analysis and Critical Control Point (HACCP) plans, Sanitation Standard Operating Procedures (SSOPs), microbiological verification sampling protocols, or other process control measures. Perform investigative work related to food processing and/or slaughter systems to obtain information, gather evidence, or verify facts in support of administrative or civil enforcement matters. Make recommendations regarding the type of enforcement action that is necessary, and assist in the preparation of enforcement related documentation such as notices of intended enforcement, suspension letters, deferral letters, and letters of warning. Collect necessary information pertaining to product recall activities, consumer complaints, or other public health concerns. Determine the relevance of data and documentation in-plant records, laboratory test data, and observed activities for compliance with provisions of laws and Agency regulations. Assist inspection personnel, as needed, in the consistent nationwide implementation of significant new inspection procedures designed to verify that official establishments meet regulatory requirements for food safety and other consumer protection. Requirements Conditions of Employment Qualifications Applicants must meet all qualifications and eligibility requirements by the closing date of the announcement including time-in-grade restrictions, specialized experience and/or education, as defined below. Time in grade: Applicants must meet one year at the next lower grade to be considered for the next higher grade (e.g. one year at the GS-09 grade level for consideration for the GS-11 grade level.) Specialized experience: In order to meet the specialized experience requirement, you will need to have completed 52 weeks of progressively responsible specialized experience at or equivalent to the next lower grade level. This experience may be gained under GS, PHHRS, another pay band system, or any combination of GS, pay band, or other experience. Specialized experience is defined as under supervision and/or guidance from senior personnel, verify safety systems for the production of products intended for consumption (e.g., food, pharmaceuticals, drinking water, biological specimens, etc.). This may include verifying of Hazard Analysis and Critical Control Point (HACCP) plans, Sanitation Standard Operating Procedures (SSOPs), Sanitation Performance Standards (SPS), Sanitation, pathogen reduction verification procedures, food security verification procedures, and other consumer protection activities (e.g., economic adulteration and misbranding, E. coli or Salmonella reduction procedures, etc.), or any interactions of these systems. This may also include experience working with federal or state regulatory requirements and enforcement actions, applying investigative methodology, documenting case files for administrative or civil enforcement actions including the collection of evidence and testimonies, implementing or monitoring recall activities and/or consumer complaints, assessing the comprehensive design and/or implementation of food safety systems, assessing microbiological sampling and testing programs, and/or monitoring quality control procedures within a food safety environment. Slaughter experience is NOT considered specialized experience. To qualify for the GS-11: 52 weeks or more of specialized experience at the next lower grade level (generally, the GS-9 level). Education can be used in lieu of specialized experience as defined below: 3 years of progressively higher level graduate education leading to a Ph.D. degree or Ph.D. or equivalent doctoral degree OR A combination of education and specialized experience - the minimum education requirement of courses consisting of at least 30 semester hours in the fields of study described above, plus appropriate experience and additional education. To qualify for the GS-12: 52 weeks or more of specialized experience at the next lower grade level (generally, the GS-11 level). Specialized experience is defined as independent and regular responsibility for verifying safety systems for the production of products intended for consumption (e.g. food, pharmaceuticals, drinking water, biological specimens, etc.). In addition to meeting the specialized experience (as stated for the GS-11), your experience for the GS-12 may come from food processing, manufacturing practices, statistical process control, microbiological testing, laboratory analytical procedures, and/or other technical areas that might affect food safety. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional, philanthropic, religious, spiritual, community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience. Education This position has a minimum education requirement to qualify at either of the advertised grades. All applicants need to meet the minimum education requirements for this position. The minimum education requirement is: A bachelor's or graduate/higher level degree in quality assurance or a related degree that included at least 30 semester hours of related course work (i.e. consumer laws, biological sciences, food science, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, legal investigations, law enforcement, or related scientific fields that provided knowledge directly related to consumer safety officer work). The 30 semester hours may include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming. OR Combination of education and experience - courses consisting of at least 30 semester hours in the fields of study described in the paragraph above, plus appropriate experience (as described under the Qualifications section) or additional education. Please view OPM's Qualifications Standards, Consumer Safety Series, GS-0696. Additional Information Career Transition Assistance Plan (CTAP), Reemployed Priority List (RPL), or Interagency Career Transition Assistance Plan (ICTAP): To exercise selection priority for this vacancy, CTAP/RPL/ICTAP candidates must meet the basic eligibility requirements and all selective factors. CTAP/ICTAP candidates must be rated and determined to be well qualified (or above) based on an evaluation of the competencies listed in the How You Will Be Evaluated section. When assessed through a score-based category rating method, CTAP/ICTAP applications must receive a rating of at least 85 out of a possible 100. This announcement may be used to fill additional like vacancies should any occur in the announced duty location(s). Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact: USDA's TARGET Center at (voice and TDD). It is the policy of the Government not to deny employment simply because an individual has been unemployed or has had financial difficulties that have arisen through no fault of the individual. See more information at: CHCO Council. Please note the following: After completing the virtual 2 week training, Consumer Safety Officers (CSO), are provided On-the-job-training (OJT). OJT consists of shadowing a more seasoned CSO during a Food Safety Assessment (FSA) in order to receive experience on the FSA process. The supervisor determines if the CSO is ready to conduct a FSA on their own or if additional OJT is needed. In addition, if feasible, the new CSO will be assigned as the secondary CSO on other FSAs so that the learning process can be extended. The supervisor provides guidance, mentoring, and information to the new CSO to assist in the transition. This position is eligible for up to 4 days telework per week and other flexible work arrangements. Employee participation is at the discretion of the supervisor. If you are selected, you may need to complete a Declaration for Federal Employment (OF-306) prior to being appointed to determine suitability for Federal employment and to authorize a background investigation. False statements or responses on a resume or application can jeopardize employment and may be grounds for disciplinary action, including removal from Federal service. CONFIDENTIAL FINANCIAL DISCLOSURE REPORT: If selected, you will be required to submit Form OGE-450 within 30 days of your initial appointment date, and annually thereafter. Selectee is subject to financial Disclosure Requirements in accordance with 5 CFR, Part 2635, Sub part E regarding business or personal transactions with applicants, borrowers, or business contacts who have or who are seeking business with this Agency. Selectee must be able to obtain and maintain a security clearance . click apply for full job details
Mar 24, 2024
Full time
Summary All Consumer Safety Officers may be detailed anywhere inside or outside the Philadelphia District to conduct Food Safety Assessments. Specific Vacancy Information: Spring Mills, PA Consumer Safety Officer (EIAO) SJ-541, GS-0696-11/12 Location: Spring Mills, PA- located in Centre County Responsibilities This position may be filled as a multi-grade career ladder. If position is filled at a developmental grade level, assignments will be of a more limited scope, performed with less independence, and may reflect limited complexity/personal contacts. You may/will: Conduct on site consumer protection assessments to verify the design and proper functioning of a plant's food safety and process control systems. Assess the scientific adequacy of Hazard Analysis and Critical Control Point (HACCP) plans, Sanitation Standard Operating Procedures (SSOPs), microbiological verification sampling protocols, or other process control measures. Perform investigative work related to food processing and/or slaughter systems to obtain information, gather evidence, or verify facts in support of administrative or civil enforcement matters. Make recommendations regarding the type of enforcement action that is necessary, and assist in the preparation of enforcement related documentation such as notices of intended enforcement, suspension letters, deferral letters, and letters of warning. Collect necessary information pertaining to product recall activities, consumer complaints, or other public health concerns. Determine the relevance of data and documentation in-plant records, laboratory test data, and observed activities for compliance with provisions of laws and Agency regulations. Assist inspection personnel, as needed, in the consistent nationwide implementation of significant new inspection procedures designed to verify that official establishments meet regulatory requirements for food safety and other consumer protection. Requirements Conditions of Employment Qualifications Applicants must meet all qualifications and eligibility requirements by the closing date of the announcement including time-in-grade restrictions, specialized experience and/or education, as defined below. Time in grade: Applicants must meet one year at the next lower grade to be considered for the next higher grade (e.g. one year at the GS-09 grade level for consideration for the GS-11 grade level.) Specialized experience: In order to meet the specialized experience requirement, you will need to have completed 52 weeks of progressively responsible specialized experience at or equivalent to the next lower grade level. This experience may be gained under GS, PHHRS, another pay band system, or any combination of GS, pay band, or other experience. Specialized experience is defined as under supervision and/or guidance from senior personnel, verify safety systems for the production of products intended for consumption (e.g., food, pharmaceuticals, drinking water, biological specimens, etc.). This may include verifying of Hazard Analysis and Critical Control Point (HACCP) plans, Sanitation Standard Operating Procedures (SSOPs), Sanitation Performance Standards (SPS), Sanitation, pathogen reduction verification procedures, food security verification procedures, and other consumer protection activities (e.g., economic adulteration and misbranding, E. coli or Salmonella reduction procedures, etc.), or any interactions of these systems. This may also include experience working with federal or state regulatory requirements and enforcement actions, applying investigative methodology, documenting case files for administrative or civil enforcement actions including the collection of evidence and testimonies, implementing or monitoring recall activities and/or consumer complaints, assessing the comprehensive design and/or implementation of food safety systems, assessing microbiological sampling and testing programs, and/or monitoring quality control procedures within a food safety environment. Slaughter experience is NOT considered specialized experience. To qualify for the GS-11: 52 weeks or more of specialized experience at the next lower grade level (generally, the GS-9 level). Education can be used in lieu of specialized experience as defined below: 3 years of progressively higher level graduate education leading to a Ph.D. degree or Ph.D. or equivalent doctoral degree OR A combination of education and specialized experience - the minimum education requirement of courses consisting of at least 30 semester hours in the fields of study described above, plus appropriate experience and additional education. To qualify for the GS-12: 52 weeks or more of specialized experience at the next lower grade level (generally, the GS-11 level). Specialized experience is defined as independent and regular responsibility for verifying safety systems for the production of products intended for consumption (e.g. food, pharmaceuticals, drinking water, biological specimens, etc.). In addition to meeting the specialized experience (as stated for the GS-11), your experience for the GS-12 may come from food processing, manufacturing practices, statistical process control, microbiological testing, laboratory analytical procedures, and/or other technical areas that might affect food safety. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional, philanthropic, religious, spiritual, community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience. Education This position has a minimum education requirement to qualify at either of the advertised grades. All applicants need to meet the minimum education requirements for this position. The minimum education requirement is: A bachelor's or graduate/higher level degree in quality assurance or a related degree that included at least 30 semester hours of related course work (i.e. consumer laws, biological sciences, food science, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, legal investigations, law enforcement, or related scientific fields that provided knowledge directly related to consumer safety officer work). The 30 semester hours may include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming. OR Combination of education and experience - courses consisting of at least 30 semester hours in the fields of study described in the paragraph above, plus appropriate experience (as described under the Qualifications section) or additional education. Please view OPM's Qualifications Standards, Consumer Safety Series, GS-0696. Additional Information Career Transition Assistance Plan (CTAP), Reemployed Priority List (RPL), or Interagency Career Transition Assistance Plan (ICTAP): To exercise selection priority for this vacancy, CTAP/RPL/ICTAP candidates must meet the basic eligibility requirements and all selective factors. CTAP/ICTAP candidates must be rated and determined to be well qualified (or above) based on an evaluation of the competencies listed in the How You Will Be Evaluated section. When assessed through a score-based category rating method, CTAP/ICTAP applications must receive a rating of at least 85 out of a possible 100. This announcement may be used to fill additional like vacancies should any occur in the announced duty location(s). Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact: USDA's TARGET Center at (voice and TDD). It is the policy of the Government not to deny employment simply because an individual has been unemployed or has had financial difficulties that have arisen through no fault of the individual. See more information at: CHCO Council. Please note the following: After completing the virtual 2 week training, Consumer Safety Officers (CSO), are provided On-the-job-training (OJT). OJT consists of shadowing a more seasoned CSO during a Food Safety Assessment (FSA) in order to receive experience on the FSA process. The supervisor determines if the CSO is ready to conduct a FSA on their own or if additional OJT is needed. In addition, if feasible, the new CSO will be assigned as the secondary CSO on other FSAs so that the learning process can be extended. The supervisor provides guidance, mentoring, and information to the new CSO to assist in the transition. This position is eligible for up to 4 days telework per week and other flexible work arrangements. Employee participation is at the discretion of the supervisor. If you are selected, you may need to complete a Declaration for Federal Employment (OF-306) prior to being appointed to determine suitability for Federal employment and to authorize a background investigation. False statements or responses on a resume or application can jeopardize employment and may be grounds for disciplinary action, including removal from Federal service. CONFIDENTIAL FINANCIAL DISCLOSURE REPORT: If selected, you will be required to submit Form OGE-450 within 30 days of your initial appointment date, and annually thereafter. Selectee is subject to financial Disclosure Requirements in accordance with 5 CFR, Part 2635, Sub part E regarding business or personal transactions with applicants, borrowers, or business contacts who have or who are seeking business with this Agency. Selectee must be able to obtain and maintain a security clearance . click apply for full job details
Food Safety and Inspection Service
Providence, Rhode Island
Summary All Consumer Safety Officers may be detailed anywhere inside or outside the Philadelphia District to conduct Food Safety Assessments. Specific Vacancy Information: Consumer Safety Officer (EIAO) SJ-541, GS-0696-11/12 Location: Providence, RI- located in Providence County Responsibilities This position may be filled as a multi-grade career ladder. If position is filled at a developmental grade level, assignments will be of a more limited scope, performed with less independence, and may reflect limited complexity/personal contacts. You may/will: Conduct on site consumer protection assessments to verify the design and proper functioning of a plant's food safety and process control systems. Assess the scientific adequacy of Hazard Analysis and Critical Control Point (HACCP) plans, Sanitation Standard Operating Procedures (SSOPs), microbiological verification sampling protocols, or other process control measures. Perform investigative work related to food processing and/or slaughter systems to obtain information, gather evidence, or verify facts in support of administrative or civil enforcement matters. Make recommendations regarding the type of enforcement action that is necessary, and assist in the preparation of enforcement related documentation such as notices of intended enforcement, suspension letters, deferral letters, and letters of warning. Collect necessary information pertaining to product recall activities, consumer complaints, or other public health concerns. Determine the relevance of data and documentation in-plant records, laboratory test data, and observed activities for compliance with provisions of laws and Agency regulations. Assist inspection personnel, as needed, in the consistent nationwide implementation of significant new inspection procedures designed to verify that official establishments meet regulatory requirements for food safety and other consumer protection. Requirements Conditions of Employment Qualifications Applicants must meet all qualifications and eligibility requirements by the closing date of the announcement including time-in-grade restrictions, specialized experience and/or education, as defined below. Time in grade: Applicants must meet one year at the next lower grade to be considered for the next higher grade (e.g. one year at the GS-09 grade level for consideration for the GS-11 grade level.) Specialized experience: In order to meet the specialized experience requirement, you will need to have completed 52 weeks of progressively responsible specialized experience at or equivalent to the next lower grade level. This experience may be gained under GS, PHHRS, another pay band system, or any combination of GS, pay band, or other experience. Specialized experience is defined as under supervision and/or guidance from senior personnel, verify safety systems for the production of products intended for consumption (e.g., food, pharmaceuticals, drinking water, biological specimens, etc.). This may include verifying of Hazard Analysis and Critical Control Point (HACCP) plans, Sanitation Standard Operating Procedures (SSOPs), Sanitation Performance Standards (SPS), Sanitation, pathogen reduction verification procedures, food security verification procedures, and other consumer protection activities (e.g., economic adulteration and misbranding, E. coli or Salmonella reduction procedures, etc.), or any interactions of these systems. This may also include experience working with federal or state regulatory requirements and enforcement actions, applying investigative methodology, documenting case files for administrative or civil enforcement actions including the collection of evidence and testimonies, implementing or monitoring recall activities and/or consumer complaints, assessing the comprehensive design and/or implementation of food safety systems, assessing microbiological sampling and testing programs, and/or monitoring quality control procedures within a food safety environment. Slaughter experience is NOT considered specialized experience. To qualify for the GS-11: 52 weeks or more of specialized experience at the next lower grade level (generally, the GS-9 level). Education can be used in lieu of specialized experience as defined below: 3 years of progressively higher level graduate education leading to a Ph.D. degree or Ph.D. or equivalent doctoral degree OR A combination of education and specialized experience - the minimum education requirement of courses consisting of at least 30 semester hours in the fields of study described above, plus appropriate experience and additional education. To qualify for the GS-12: 52 weeks or more of specialized experience at the next lower grade level (generally, the GS-11 level). Specialized experience is defined as independent and regular responsibility for verifying safety systems for the production of products intended for consumption (e.g. food, pharmaceuticals, drinking water, biological specimens, etc.). In addition to meeting the specialized experience (as stated for the GS-11), your experience for the GS-12 may come from food processing, manufacturing practices, statistical process control, microbiological testing, laboratory analytical procedures, and/or other technical areas that might affect food safety. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional, philanthropic, religious, spiritual, community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience. Education This position has a minimum education requirement to qualify at either of the advertised grades. All applicants need to meet the minimum education requirements for this position. The minimum education requirement is: A bachelor's or graduate/higher level degree in quality assurance or a related degree that included at least 30 semester hours of related course work (i.e. consumer laws, biological sciences, food science, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, legal investigations, law enforcement, or related scientific fields that provided knowledge directly related to consumer safety officer work). The 30 semester hours may include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming. OR Combination of education and experience - courses consisting of at least 30 semester hours in the fields of study described in the paragraph above, plus appropriate experience (as described under the Qualifications section) or additional education. Please view OPM's Qualifications Standards, Consumer Safety Series, GS-0696. Additional Information Career Transition Assistance Plan (CTAP), Reemployed Priority List (RPL), or Interagency Career Transition Assistance Plan (ICTAP): To exercise selection priority for this vacancy, CTAP/RPL/ICTAP candidates must meet the basic eligibility requirements and all selective factors. CTAP/ICTAP candidates must be rated and determined to be well qualified (or above) based on an evaluation of the competencies listed in the How You Will Be Evaluated section. When assessed through a score-based category rating method, CTAP/ICTAP applications must receive a rating of at least 85 out of a possible 100. This announcement may be used to fill additional like vacancies should any occur in the announced duty location(s). Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact: USDA's TARGET Center at (voice and TDD). It is the policy of the Government not to deny employment simply because an individual has been unemployed or has had financial difficulties that have arisen through no fault of the individual. See more information at: CHCO Council. Please note the following: After completing the virtual 2 week training, Consumer Safety Officers (CSO), are provided On-the-job-training (OJT). OJT consists of shadowing a more seasoned CSO during a Food Safety Assessment (FSA) in order to receive experience on the FSA process. The supervisor determines if the CSO is ready to conduct a FSA on their own or if additional OJT is needed. In addition, if feasible, the new CSO will be assigned as the secondary CSO on other FSAs so that the learning process can be extended. The supervisor provides guidance, mentoring, and information to the new CSO to assist in the transition. This position is eligible for up to 4 days telework per week and other flexible work arrangements. Employee participation is at the discretion of the supervisor. If you are selected, you may need to complete a Declaration for Federal Employment (OF-306) prior to being appointed to determine suitability for Federal employment and to authorize a background investigation. False statements or responses on a resume or application can jeopardize employment and may be grounds for disciplinary action, including removal from Federal service. CONFIDENTIAL FINANCIAL DISCLOSURE REPORT: If selected, you will be required to submit Form OGE-450 within 30 days of your initial appointment date, and annually thereafter. Selectee is subject to financial Disclosure Requirements in accordance with 5 CFR, Part 2635, Sub part E regarding business or personal transactions with applicants, borrowers, or business contacts who have or who are seeking business with this Agency. Selectee must be able to obtain and maintain a security clearance . click apply for full job details
Mar 24, 2024
Full time
Summary All Consumer Safety Officers may be detailed anywhere inside or outside the Philadelphia District to conduct Food Safety Assessments. Specific Vacancy Information: Consumer Safety Officer (EIAO) SJ-541, GS-0696-11/12 Location: Providence, RI- located in Providence County Responsibilities This position may be filled as a multi-grade career ladder. If position is filled at a developmental grade level, assignments will be of a more limited scope, performed with less independence, and may reflect limited complexity/personal contacts. You may/will: Conduct on site consumer protection assessments to verify the design and proper functioning of a plant's food safety and process control systems. Assess the scientific adequacy of Hazard Analysis and Critical Control Point (HACCP) plans, Sanitation Standard Operating Procedures (SSOPs), microbiological verification sampling protocols, or other process control measures. Perform investigative work related to food processing and/or slaughter systems to obtain information, gather evidence, or verify facts in support of administrative or civil enforcement matters. Make recommendations regarding the type of enforcement action that is necessary, and assist in the preparation of enforcement related documentation such as notices of intended enforcement, suspension letters, deferral letters, and letters of warning. Collect necessary information pertaining to product recall activities, consumer complaints, or other public health concerns. Determine the relevance of data and documentation in-plant records, laboratory test data, and observed activities for compliance with provisions of laws and Agency regulations. Assist inspection personnel, as needed, in the consistent nationwide implementation of significant new inspection procedures designed to verify that official establishments meet regulatory requirements for food safety and other consumer protection. Requirements Conditions of Employment Qualifications Applicants must meet all qualifications and eligibility requirements by the closing date of the announcement including time-in-grade restrictions, specialized experience and/or education, as defined below. Time in grade: Applicants must meet one year at the next lower grade to be considered for the next higher grade (e.g. one year at the GS-09 grade level for consideration for the GS-11 grade level.) Specialized experience: In order to meet the specialized experience requirement, you will need to have completed 52 weeks of progressively responsible specialized experience at or equivalent to the next lower grade level. This experience may be gained under GS, PHHRS, another pay band system, or any combination of GS, pay band, or other experience. Specialized experience is defined as under supervision and/or guidance from senior personnel, verify safety systems for the production of products intended for consumption (e.g., food, pharmaceuticals, drinking water, biological specimens, etc.). This may include verifying of Hazard Analysis and Critical Control Point (HACCP) plans, Sanitation Standard Operating Procedures (SSOPs), Sanitation Performance Standards (SPS), Sanitation, pathogen reduction verification procedures, food security verification procedures, and other consumer protection activities (e.g., economic adulteration and misbranding, E. coli or Salmonella reduction procedures, etc.), or any interactions of these systems. This may also include experience working with federal or state regulatory requirements and enforcement actions, applying investigative methodology, documenting case files for administrative or civil enforcement actions including the collection of evidence and testimonies, implementing or monitoring recall activities and/or consumer complaints, assessing the comprehensive design and/or implementation of food safety systems, assessing microbiological sampling and testing programs, and/or monitoring quality control procedures within a food safety environment. Slaughter experience is NOT considered specialized experience. To qualify for the GS-11: 52 weeks or more of specialized experience at the next lower grade level (generally, the GS-9 level). Education can be used in lieu of specialized experience as defined below: 3 years of progressively higher level graduate education leading to a Ph.D. degree or Ph.D. or equivalent doctoral degree OR A combination of education and specialized experience - the minimum education requirement of courses consisting of at least 30 semester hours in the fields of study described above, plus appropriate experience and additional education. To qualify for the GS-12: 52 weeks or more of specialized experience at the next lower grade level (generally, the GS-11 level). Specialized experience is defined as independent and regular responsibility for verifying safety systems for the production of products intended for consumption (e.g. food, pharmaceuticals, drinking water, biological specimens, etc.). In addition to meeting the specialized experience (as stated for the GS-11), your experience for the GS-12 may come from food processing, manufacturing practices, statistical process control, microbiological testing, laboratory analytical procedures, and/or other technical areas that might affect food safety. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional, philanthropic, religious, spiritual, community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience. Education This position has a minimum education requirement to qualify at either of the advertised grades. All applicants need to meet the minimum education requirements for this position. The minimum education requirement is: A bachelor's or graduate/higher level degree in quality assurance or a related degree that included at least 30 semester hours of related course work (i.e. consumer laws, biological sciences, food science, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, legal investigations, law enforcement, or related scientific fields that provided knowledge directly related to consumer safety officer work). The 30 semester hours may include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming. OR Combination of education and experience - courses consisting of at least 30 semester hours in the fields of study described in the paragraph above, plus appropriate experience (as described under the Qualifications section) or additional education. Please view OPM's Qualifications Standards, Consumer Safety Series, GS-0696. Additional Information Career Transition Assistance Plan (CTAP), Reemployed Priority List (RPL), or Interagency Career Transition Assistance Plan (ICTAP): To exercise selection priority for this vacancy, CTAP/RPL/ICTAP candidates must meet the basic eligibility requirements and all selective factors. CTAP/ICTAP candidates must be rated and determined to be well qualified (or above) based on an evaluation of the competencies listed in the How You Will Be Evaluated section. When assessed through a score-based category rating method, CTAP/ICTAP applications must receive a rating of at least 85 out of a possible 100. This announcement may be used to fill additional like vacancies should any occur in the announced duty location(s). Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact: USDA's TARGET Center at (voice and TDD). It is the policy of the Government not to deny employment simply because an individual has been unemployed or has had financial difficulties that have arisen through no fault of the individual. See more information at: CHCO Council. Please note the following: After completing the virtual 2 week training, Consumer Safety Officers (CSO), are provided On-the-job-training (OJT). OJT consists of shadowing a more seasoned CSO during a Food Safety Assessment (FSA) in order to receive experience on the FSA process. The supervisor determines if the CSO is ready to conduct a FSA on their own or if additional OJT is needed. In addition, if feasible, the new CSO will be assigned as the secondary CSO on other FSAs so that the learning process can be extended. The supervisor provides guidance, mentoring, and information to the new CSO to assist in the transition. This position is eligible for up to 4 days telework per week and other flexible work arrangements. Employee participation is at the discretion of the supervisor. If you are selected, you may need to complete a Declaration for Federal Employment (OF-306) prior to being appointed to determine suitability for Federal employment and to authorize a background investigation. False statements or responses on a resume or application can jeopardize employment and may be grounds for disciplinary action, including removal from Federal service. CONFIDENTIAL FINANCIAL DISCLOSURE REPORT: If selected, you will be required to submit Form OGE-450 within 30 days of your initial appointment date, and annually thereafter. Selectee is subject to financial Disclosure Requirements in accordance with 5 CFR, Part 2635, Sub part E regarding business or personal transactions with applicants, borrowers, or business contacts who have or who are seeking business with this Agency. Selectee must be able to obtain and maintain a security clearance . click apply for full job details
As a Cake Decorator you will drive member service in your area to deliver to our members more of what they love, for less. You will work collaboratively with other associates to ensure the total club meets the member's expectations. What you'll do Be a Team Member: Collaborates with cross functional teams and helps educate other associates on tools, tasks, and resources; communicates and develops interpersonal skills for providing customer service; being flexible to the needs of the business; maintaining in-stock levels; and controlling shrinkage. Be an Expert: Plans the bakery productions; ensuring consistency in quality and accuracy of bakery decorative designs; following recipe measurement instructions; working with a variety of products (for example, decorating bags, tips, nozzles) to create decorative flowers and lettering on bakery items; ensuring adherence to food safety standards, sanitation guidelines, cold chain compliance, and inventory management; operating, maintaining, and sanitizing equipment; and demonstrating understanding of product and layout execution. Be a Techie: Leverages digital tools to drive sales, improve the shopping experience, and elevate associate engagement; utilizing hand held technology to make immediate business decisions related to production, merchandise ordering, training, and product quality with the member in mind; adapting to new tools and encouraging others to use them. Be an Owner: Drives the performance of the bakery area; ensuring quality and date control standards; eliminating waste; preparing for seasonal events that impact the bakery volume (for example, holidays, graduations, family events); identifying member needs; assisting members with purchasing decisions; and resolving member issues and concerns. Be a Talent Ambassador: Being a brand advocate by valuing the member's experience in Bakery and modeling high quality service and products; interacting with associates to understand the roadblocks and assisting in training; developing, influencing and inspiring them for working in a style that is respectful, supportive and team oriented. Complies with company policies, procedures, and standards of ethics and integrity by implementing related action plans; using the Open Door Policy; and applying these in executing business processes and practices. Completes work assignments and priorities by using policies, data, and resources; collaborating with managers, co-workers, customers, and other business partners; identifying priorities, deadlines, and expectations; carrying out tasks; communicating progress and information; determining and recommending ways to address improvement opportunities; and adapting to and learning from change, difficulties, and feedback. At Sam's Club, we offer competitive pay as well as performance-based incentive awards and other great benefits for a happier mind, body, and wallet. Health benefits include medical, vision and dental coverage. Financial benefits include 401(k), stock purchase and company-paid life insurance. Paid time off benefits include PTO (including sick leave), parental leave, family care leave, bereavement, jury duty and voting. Other benefits include short-term and long-term disability, company discounts, Military Leave Pay, adoption and surrogacy expense reimbursement, and more. You will also receive PTO and/or PPTO that can be used for vacation, sick leave, holidays, or other purposes. The amount you receive depends on your job classification and length of employment. It will meet or exceed the requirements of paid sick leave laws, where applicable. For information about PTO, see Live Better U is a Walmart-paid education benefit program for full-time and part-time associates in Walmart and Sam's Club facilities. Programs range from high school completion to bachelor's degrees, including English Language Learning and short-form certificates. Tuition, books, and fees are completely paid for by Walmart Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms. For information about benefits and eligibility, see The hourly wage range for this position is $19.00 to $26.00 The actual hourly rate will equal or exceed the required minimum wage applicable to the job location. Additional Compensation Includes Annual Or Quarterly Performance Incentives. Additional compensation in the form of premiums may be paid in amounts ranging from $0.35 per hour to $3.00 per hour in specific circumstances. Premiums may be based on schedule, facility, season, or specific work performed. Multiple premiums may apply if applicable criteria are met. Minimum Qualifications _Outlined below are the required minimum qualifications for this position. If none are listed, there are no minimum qualifications._ Minimum Qualifications6 months' experience in fresh production area. Must be 18 years of age or older I acknowledge that the position for which I am applying requires me to successfully complete all job required trainings and assessments within a prescribed time period if I receive the position. Preferred Qualifications _Outlined below are the optional preferred qualifications for this position. If none are listed, there are no preferred qualifications._ Cake Decorating Primary Location 2950 HORSEBLOCK RD, MEDFORD, NY , United States of America About Sam's Club Sam Walton opened the first Sam's Club in 1983 to meet a growing need among customers who wanted to buy merchandise in bulk. Since then, Sam's Club has grown rapidly, opening more than 600 clubs in the U.S. and 100 clubs internationally. By offering affordable, wholesale merchandise to members, Sam's Club helps make saving simple for families and small business owners. Sam's Club employs about 110,000 associates in the U.S. The average club is 134,000 square feet and offers bulk groceries and general merchandise. Most clubs also have specialty services, such as a pharmacy, an optical department, a photo center, or a tire and battery center. _Sam's Club is an Equal Opportunity Employer- By Choice. We believe we are best equipped to help our associates, customers, and the communities we serve live better when we really know them. That means understanding, respecting, and valuing diversity- unique styles, experiences, identities, abilities, ideas and opinions- while being inclusive of all people._ All the benefits you need for you and your family Multiple health plan options, including vision & dental plans for you & dependents Free Membership and discounts in fresh produce Financial benefits including 401(k), stock purchase plans, life insurance and more Paid education assistance with college degrees through our Live Better U program Parental Leave Pay during military service Paid time off - to include vacation, sick leave and parental leave Short-term and long-term disability for when you can't work because of injury, illness, or childbirth Job Type: Full-time Pay: $19.00 - $26.00 per hour
Mar 18, 2024
Full time
As a Cake Decorator you will drive member service in your area to deliver to our members more of what they love, for less. You will work collaboratively with other associates to ensure the total club meets the member's expectations. What you'll do Be a Team Member: Collaborates with cross functional teams and helps educate other associates on tools, tasks, and resources; communicates and develops interpersonal skills for providing customer service; being flexible to the needs of the business; maintaining in-stock levels; and controlling shrinkage. Be an Expert: Plans the bakery productions; ensuring consistency in quality and accuracy of bakery decorative designs; following recipe measurement instructions; working with a variety of products (for example, decorating bags, tips, nozzles) to create decorative flowers and lettering on bakery items; ensuring adherence to food safety standards, sanitation guidelines, cold chain compliance, and inventory management; operating, maintaining, and sanitizing equipment; and demonstrating understanding of product and layout execution. Be a Techie: Leverages digital tools to drive sales, improve the shopping experience, and elevate associate engagement; utilizing hand held technology to make immediate business decisions related to production, merchandise ordering, training, and product quality with the member in mind; adapting to new tools and encouraging others to use them. Be an Owner: Drives the performance of the bakery area; ensuring quality and date control standards; eliminating waste; preparing for seasonal events that impact the bakery volume (for example, holidays, graduations, family events); identifying member needs; assisting members with purchasing decisions; and resolving member issues and concerns. Be a Talent Ambassador: Being a brand advocate by valuing the member's experience in Bakery and modeling high quality service and products; interacting with associates to understand the roadblocks and assisting in training; developing, influencing and inspiring them for working in a style that is respectful, supportive and team oriented. Complies with company policies, procedures, and standards of ethics and integrity by implementing related action plans; using the Open Door Policy; and applying these in executing business processes and practices. Completes work assignments and priorities by using policies, data, and resources; collaborating with managers, co-workers, customers, and other business partners; identifying priorities, deadlines, and expectations; carrying out tasks; communicating progress and information; determining and recommending ways to address improvement opportunities; and adapting to and learning from change, difficulties, and feedback. At Sam's Club, we offer competitive pay as well as performance-based incentive awards and other great benefits for a happier mind, body, and wallet. Health benefits include medical, vision and dental coverage. Financial benefits include 401(k), stock purchase and company-paid life insurance. Paid time off benefits include PTO (including sick leave), parental leave, family care leave, bereavement, jury duty and voting. Other benefits include short-term and long-term disability, company discounts, Military Leave Pay, adoption and surrogacy expense reimbursement, and more. You will also receive PTO and/or PPTO that can be used for vacation, sick leave, holidays, or other purposes. The amount you receive depends on your job classification and length of employment. It will meet or exceed the requirements of paid sick leave laws, where applicable. For information about PTO, see Live Better U is a Walmart-paid education benefit program for full-time and part-time associates in Walmart and Sam's Club facilities. Programs range from high school completion to bachelor's degrees, including English Language Learning and short-form certificates. Tuition, books, and fees are completely paid for by Walmart Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms. For information about benefits and eligibility, see The hourly wage range for this position is $19.00 to $26.00 The actual hourly rate will equal or exceed the required minimum wage applicable to the job location. Additional Compensation Includes Annual Or Quarterly Performance Incentives. Additional compensation in the form of premiums may be paid in amounts ranging from $0.35 per hour to $3.00 per hour in specific circumstances. Premiums may be based on schedule, facility, season, or specific work performed. Multiple premiums may apply if applicable criteria are met. Minimum Qualifications _Outlined below are the required minimum qualifications for this position. If none are listed, there are no minimum qualifications._ Minimum Qualifications6 months' experience in fresh production area. Must be 18 years of age or older I acknowledge that the position for which I am applying requires me to successfully complete all job required trainings and assessments within a prescribed time period if I receive the position. Preferred Qualifications _Outlined below are the optional preferred qualifications for this position. If none are listed, there are no preferred qualifications._ Cake Decorating Primary Location 2950 HORSEBLOCK RD, MEDFORD, NY , United States of America About Sam's Club Sam Walton opened the first Sam's Club in 1983 to meet a growing need among customers who wanted to buy merchandise in bulk. Since then, Sam's Club has grown rapidly, opening more than 600 clubs in the U.S. and 100 clubs internationally. By offering affordable, wholesale merchandise to members, Sam's Club helps make saving simple for families and small business owners. Sam's Club employs about 110,000 associates in the U.S. The average club is 134,000 square feet and offers bulk groceries and general merchandise. Most clubs also have specialty services, such as a pharmacy, an optical department, a photo center, or a tire and battery center. _Sam's Club is an Equal Opportunity Employer- By Choice. We believe we are best equipped to help our associates, customers, and the communities we serve live better when we really know them. That means understanding, respecting, and valuing diversity- unique styles, experiences, identities, abilities, ideas and opinions- while being inclusive of all people._ All the benefits you need for you and your family Multiple health plan options, including vision & dental plans for you & dependents Free Membership and discounts in fresh produce Financial benefits including 401(k), stock purchase plans, life insurance and more Paid education assistance with college degrees through our Live Better U program Parental Leave Pay during military service Paid time off - to include vacation, sick leave and parental leave Short-term and long-term disability for when you can't work because of injury, illness, or childbirth Job Type: Full-time Pay: $19.00 - $26.00 per hour