Quality Assurance Process Team Device Assembly and Packaging
Eli Lilly and Company
August 11, 2026
On-site
Concord, NC
Operations
Responsibilities:
- Demonstrate leadership, teamwork, and quality knowledge day to day; lead, mentor, and coach operations/support personnel on quality matters.
- Support deviations, change controls, procedure updates, commissioning, and qualification activities; maintain regular presence in operational areas to monitor/confirm execution to quality standards.
- Participate on local process team for: Device Assembly, Packaging, or Project Focus for DAP.
- Provide quality oversight for verification/qualification of manufacturing equipment and buildings (review test cases, support test execution, discrepancy resolution).
- Guide resolution/review/approval of deviations and change controls; ensure compliance issues are resolved/escalated.
- Lead annual quality floor time plan; support batch documentation (alarm response, exceptions), asset qualification monitoring reviews, and continuous improvements.
- Measure/maintain/achieve quality metrics; attend daily process team meeting and update on quality.
- Respond to operational issues outside core business hours/days; work onsite 8-hour shifts and overtime as required.
Basic Requirements:
- Bachelor’s degree in a scientific field.
- 4+ years’ experience in Quality pharmaceutical manufacturing.
- C&Q/Verification & Validation oversight experience, including automation and computer systems validation.
- Legal authorization to work in the United States; no sponsorship anticipated for specified visa paths/levels.
Additional Skills/Preferences:
- ASQ Certified; CSQA experience.
- Device assembly/packaging experience; MES/MES-related systems; KNEAT/electronic validation software.
- Technical writing; proficiency with SAP/Trackwise/MES; knowledge of US/EU/Japan regulations; cross-functional communication; independent quality SME.
Compensation & Benefits:
- Anticipated wage: $65,250–$169,400.
- Eligible for company bonus and comprehensive benefits (e.g., 401(k), pension, vacation, medical/dental/vision, flexible benefits, life insurance, time off/leave, well-being benefits).
- Demonstrate leadership, teamwork, and quality knowledge day to day; lead, mentor, and coach operations/support personnel on quality matters.
- Support deviations, change controls, procedure updates, commissioning, and qualification activities; maintain regular presence in operational areas to monitor/confirm execution to quality standards.
- Participate on local process team for: Device Assembly, Packaging, or Project Focus for DAP.
- Provide quality oversight for verification/qualification of manufacturing equipment and buildings (review test cases, support test execution, discrepancy resolution).
- Guide resolution/review/approval of deviations and change controls; ensure compliance issues are resolved/escalated.
- Lead annual quality floor time plan; support batch documentation (alarm response, exceptions), asset qualification monitoring reviews, and continuous improvements.
- Measure/maintain/achieve quality metrics; attend daily process team meeting and update on quality.
- Respond to operational issues outside core business hours/days; work onsite 8-hour shifts and overtime as required.
Basic Requirements:
- Bachelor’s degree in a scientific field.
- 4+ years’ experience in Quality pharmaceutical manufacturing.
- C&Q/Verification & Validation oversight experience, including automation and computer systems validation.
- Legal authorization to work in the United States; no sponsorship anticipated for specified visa paths/levels.
Additional Skills/Preferences:
- ASQ Certified; CSQA experience.
- Device assembly/packaging experience; MES/MES-related systems; KNEAT/electronic validation software.
- Technical writing; proficiency with SAP/Trackwise/MES; knowledge of US/EU/Japan regulations; cross-functional communication; independent quality SME.
Compensation & Benefits:
- Anticipated wage: $65,250–$169,400.
- Eligible for company bonus and comprehensive benefits (e.g., 401(k), pension, vacation, medical/dental/vision, flexible benefits, life insurance, time off/leave, well-being benefits).