Eli Lilly and Company
Indianapolis, Indiana
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Description: The QA Data Steward within Indianapolis Parenteral Manufacturing is responsible for the creation/verification of Certificates of Analysis for semi-finished and finished commercial batches. In addition, the QA Data Steward is responsible for oversight of critical data maintained within one or more automated system, such as SAP, TrackWise, QualityDocs/Veeva, and Darwin. The QA Data Steward performs impact analyses, ensures all data changes are properly documented and controlled, implements/verifies system changes, and performs system audits, where applicable, to ensure data integrity. Key Objectives/Deliverables: Provide oversight and implement/verify changes of Q-Info Records and Inspection Plans in SAP Provide oversight of the TrackWise system, including the processing of records and performance of system audits, as required Process revisions/creations of QualityDocs/Veeva Specifications, as required, per approved Change Controls and RCM Matrix revisions Process revisions/creations of Darwin product, specification, test allocation, and sampling plan master data records within the Darwin LIMS system Perform timely, accurate impact analyses for changes with impact to SAP, Veeva, and/or Darwin records Create/Verify Certificates of Analysis for semi-finished and finished commercial batches Support projects/initiatives that may impact data stewardship processes and procedures, as needed Minimum Requirements: Experience working in SAP, TrackWise, QualityDocs/Veeva, and/or Darwin Strict attention to detail and ability to maintain compliance issues and meeting critical deadlines. Overall business understanding including proposal of changes, implementation and related regulations; and pharmacopoeia requirements. Excellent written and oral communication skills, troubleshooting and investigating skills, and crisis decision-making skills. Strong organizational skills - ability to handle/prioritize multiple projects and requests. Ability to interact effectively with a variety of people - good teamwork skills. Effective training skills and ability to coach others. Familiarity with cGMPs and corporate policies and procedures. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Additional Preferences: General understanding of laboratory and/or operations techniques and terminology. Previous experience in operations, quality control, and/or regulatory. Proficient in Microsoft Word/Excel/Power Point. Education Requirements: High School Graduate or equivalent. Other Information: Shift schedule: Monday-Friday 8am-5pm Overtime may be required. May be required to support off shift activities related to operational issues. Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position. Minimal travel required May be subject to Post Offer Exam Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Description: The QA Data Steward within Indianapolis Parenteral Manufacturing is responsible for the creation/verification of Certificates of Analysis for semi-finished and finished commercial batches. In addition, the QA Data Steward is responsible for oversight of critical data maintained within one or more automated system, such as SAP, TrackWise, QualityDocs/Veeva, and Darwin. The QA Data Steward performs impact analyses, ensures all data changes are properly documented and controlled, implements/verifies system changes, and performs system audits, where applicable, to ensure data integrity. Key Objectives/Deliverables: Provide oversight and implement/verify changes of Q-Info Records and Inspection Plans in SAP Provide oversight of the TrackWise system, including the processing of records and performance of system audits, as required Process revisions/creations of QualityDocs/Veeva Specifications, as required, per approved Change Controls and RCM Matrix revisions Process revisions/creations of Darwin product, specification, test allocation, and sampling plan master data records within the Darwin LIMS system Perform timely, accurate impact analyses for changes with impact to SAP, Veeva, and/or Darwin records Create/Verify Certificates of Analysis for semi-finished and finished commercial batches Support projects/initiatives that may impact data stewardship processes and procedures, as needed Minimum Requirements: Experience working in SAP, TrackWise, QualityDocs/Veeva, and/or Darwin Strict attention to detail and ability to maintain compliance issues and meeting critical deadlines. Overall business understanding including proposal of changes, implementation and related regulations; and pharmacopoeia requirements. Excellent written and oral communication skills, troubleshooting and investigating skills, and crisis decision-making skills. Strong organizational skills - ability to handle/prioritize multiple projects and requests. Ability to interact effectively with a variety of people - good teamwork skills. Effective training skills and ability to coach others. Familiarity with cGMPs and corporate policies and procedures. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Additional Preferences: General understanding of laboratory and/or operations techniques and terminology. Previous experience in operations, quality control, and/or regulatory. Proficient in Microsoft Word/Excel/Power Point. Education Requirements: High School Graduate or equivalent. Other Information: Shift schedule: Monday-Friday 8am-5pm Overtime may be required. May be required to support off shift activities related to operational issues. Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position. Minimal travel required May be subject to Post Offer Exam Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Bakerly Barn LLC
Easton, Pennsylvania
Description:Scope/Purpose of the Position The Quality Assurance Manager will be responsible for leading the company's food safety and quality systems to be effective and continuously improving. The Quality Assurance Manager will be the main contact for internal and external relations regarding products quality, and will ensure the delivery of safe, quality, product. The responsibility for developing the QA technicians and assistant by investing time through relevant job training, empowerment, and engagement will be critical for the success of this position. Requirements:Major Responsibilities and Essential Functions Responsible for managing 8 quality technicians and 1 quality supervisor while performing all supervisor/HR tasks such as hiring, scheduling, discipline, professional development, and payroll. Develop, implement, and maintain all food safety and quality systems in a constantly changing production plant environment. Educate and continuously develop an effective Food Safety Culture Define, re-assess, and maintain site HACCP/HARPC plans. Ensure the implementation of all controls outlined in the food safety plans. Manage the site-specific Complaints Program while ensuring a thorough root cause analysis into customer complaints Develop monitoring activities to collect and analyze data to improve department specific KPIs Drive continuous improvement within the plant utilizing cross-department and external resources. Manage internal and external (SQF/Customer/Kosher/Non-GE) auditing program. Job Qualification Requirements Bachelor's degree in science or Management, or equivalent work experience Minimum of 5 years of food processing and quality experience Minimum of 3 years' experience in a management position in a food manufacturing environment HACCP, PSQM, and SQF certification Strong knowledge of FDA laws and regulations Strong knowledge of Food Safety (HACCP principles, GFSI/BRC/SQF, GMPs, SOPs, SSOPs, Pest Control, Kosher, ORGANIC and Allergen Control programs) Proficient with Microsoft Office (Word, Excel, and Power Point) Flexibility to work overtime if needed, and good attendance Ability to stand, walk, stoop, kneel, bend, climb stairs, and lift up to 55 lbs. Strong knowledge of laboratory equipment, GMP, HACCP, SQF or other GFSI schemes Excellent written and oral communication skills Backup The Quality Supervisor is the Backup when the Quality Assurance Manager is absent. PI1bc2a88fb1-
Description:Scope/Purpose of the Position The Quality Assurance Manager will be responsible for leading the company's food safety and quality systems to be effective and continuously improving. The Quality Assurance Manager will be the main contact for internal and external relations regarding products quality, and will ensure the delivery of safe, quality, product. The responsibility for developing the QA technicians and assistant by investing time through relevant job training, empowerment, and engagement will be critical for the success of this position. Requirements:Major Responsibilities and Essential Functions Responsible for managing 8 quality technicians and 1 quality supervisor while performing all supervisor/HR tasks such as hiring, scheduling, discipline, professional development, and payroll. Develop, implement, and maintain all food safety and quality systems in a constantly changing production plant environment. Educate and continuously develop an effective Food Safety Culture Define, re-assess, and maintain site HACCP/HARPC plans. Ensure the implementation of all controls outlined in the food safety plans. Manage the site-specific Complaints Program while ensuring a thorough root cause analysis into customer complaints Develop monitoring activities to collect and analyze data to improve department specific KPIs Drive continuous improvement within the plant utilizing cross-department and external resources. Manage internal and external (SQF/Customer/Kosher/Non-GE) auditing program. Job Qualification Requirements Bachelor's degree in science or Management, or equivalent work experience Minimum of 5 years of food processing and quality experience Minimum of 3 years' experience in a management position in a food manufacturing environment HACCP, PSQM, and SQF certification Strong knowledge of FDA laws and regulations Strong knowledge of Food Safety (HACCP principles, GFSI/BRC/SQF, GMPs, SOPs, SSOPs, Pest Control, Kosher, ORGANIC and Allergen Control programs) Proficient with Microsoft Office (Word, Excel, and Power Point) Flexibility to work overtime if needed, and good attendance Ability to stand, walk, stoop, kneel, bend, climb stairs, and lift up to 55 lbs. Strong knowledge of laboratory equipment, GMP, HACCP, SQF or other GFSI schemes Excellent written and oral communication skills Backup The Quality Supervisor is the Backup when the Quality Assurance Manager is absent. PI1bc2a88fb1-
Bakerly Barn LLC
Easton, Pennsylvania
Description:Scope/Purpose of the Position The Quality Assurance Manager will be responsible for leading the company's food safety and quality systems to be effective and continuously improving. The Quality Assurance Manager will be the main contact for internal and external relations regarding products quality, and will ensure the delivery of safe, quality, product. The responsibility for developing the QA technicians and assistant by investing time through relevant job training, empowerment, and engagement will be critical for the success of this position. Requirements:Major Responsibilities and Essential Functions Responsible for managing 8 quality technicians and 1 quality supervisor while performing all supervisor/HR tasks such as hiring, scheduling, discipline, professional development, and payroll. Develop, implement, and maintain all food safety and quality systems in a constantly changing production plant environment. Educate and continuously develop an effective Food Safety Culture Define, re-assess, and maintain site HACCP/HARPC plans. Ensure the implementation of all controls outlined in the food safety plans. Manage the site-specific Complaints Program while ensuring a thorough root cause analysis into customer complaints Develop monitoring activities to collect and analyze data to improve department specific KPIs Drive continuous improvement within the plant utilizing cross-department and external resources. Manage internal and external (SQF/Customer/Kosher/Non-GE) auditing program. Job Qualification Requirements Bachelor's degree in science or Management, or equivalent work experience Minimum of 5 years of food processing and quality experience Minimum of 3 years' experience in a management position in a food manufacturing environment HACCP, PSQM, and SQF certification Strong knowledge of FDA laws and regulations Strong knowledge of Food Safety (HACCP principles, GFSI/BRC/SQF, GMPs, SOPs, SSOPs, Pest Control, Kosher, ORGANIC and Allergen Control programs) Proficient with Microsoft Office (Word, Excel, and Power Point) Flexibility to work overtime if needed, and good attendance Ability to stand, walk, stoop, kneel, bend, climb stairs, and lift up to 55 lbs. Strong knowledge of laboratory equipment, GMP, HACCP, SQF or other GFSI schemes Excellent written and oral communication skills Backup The Quality Supervisor is the Backup when the Quality Assurance Manager is absent. PI1bc2a88fb1-
Description:Scope/Purpose of the Position The Quality Assurance Manager will be responsible for leading the company's food safety and quality systems to be effective and continuously improving. The Quality Assurance Manager will be the main contact for internal and external relations regarding products quality, and will ensure the delivery of safe, quality, product. The responsibility for developing the QA technicians and assistant by investing time through relevant job training, empowerment, and engagement will be critical for the success of this position. Requirements:Major Responsibilities and Essential Functions Responsible for managing 8 quality technicians and 1 quality supervisor while performing all supervisor/HR tasks such as hiring, scheduling, discipline, professional development, and payroll. Develop, implement, and maintain all food safety and quality systems in a constantly changing production plant environment. Educate and continuously develop an effective Food Safety Culture Define, re-assess, and maintain site HACCP/HARPC plans. Ensure the implementation of all controls outlined in the food safety plans. Manage the site-specific Complaints Program while ensuring a thorough root cause analysis into customer complaints Develop monitoring activities to collect and analyze data to improve department specific KPIs Drive continuous improvement within the plant utilizing cross-department and external resources. Manage internal and external (SQF/Customer/Kosher/Non-GE) auditing program. Job Qualification Requirements Bachelor's degree in science or Management, or equivalent work experience Minimum of 5 years of food processing and quality experience Minimum of 3 years' experience in a management position in a food manufacturing environment HACCP, PSQM, and SQF certification Strong knowledge of FDA laws and regulations Strong knowledge of Food Safety (HACCP principles, GFSI/BRC/SQF, GMPs, SOPs, SSOPs, Pest Control, Kosher, ORGANIC and Allergen Control programs) Proficient with Microsoft Office (Word, Excel, and Power Point) Flexibility to work overtime if needed, and good attendance Ability to stand, walk, stoop, kneel, bend, climb stairs, and lift up to 55 lbs. Strong knowledge of laboratory equipment, GMP, HACCP, SQF or other GFSI schemes Excellent written and oral communication skills Backup The Quality Supervisor is the Backup when the Quality Assurance Manager is absent. PI1bc2a88fb1-