Sr. Principal Associate - Quality AQR
Eli Lilly and Company
4 months ago
On-site
Indianapolis, IN
Operations
Sr. Principal Associate QA Authorized Quality Representative (AQR)
Responsibilities:
- Provide final disposition of finished drug products; guide the site on technical, quality, and compliance issues for batch release and annual product review.
- Ensure adherence to Global/Local Quality requirements and adequate quality systems for Batch Disposition to meet applicable GMP standards.
- Coach/mentor process teams and operations quality; develop capabilities across quality assurance/compliance and device assembly plus wet/dry packaging.
- Support regulatory inspections as a subject matter expert for batch release topics.
- Lead safety initiatives and support all HSE Corporate and Site goals.
- Own/serve as SME for change controls, deviations, process validation, and other quality items tied to batch release and annual product review.
- Perform final batch disposition of semi-finished/finished batches (commercial, clinical, non-commercial) for Indianapolis device assembly/packaging.
- Liaison for evaluation/completion of shipments under quarantine.
- Qualify quality representatives for vials, sub-assembly, final assembly, and dry packaging; contribute to execution of APRs.
- Review/approve GMP documents (nonconformances, procedures, protocols, specifications, change controls); lead improvements and support inspections.
- Provide technical leadership for major/significant deviations and investigations.
Minimum requirements:
- Bachelor’s degree in chemistry/science/engineering/pharmacy.
- Experience supporting pharmaceutical manufacturing or quality.
- Ability to make technical decisions, guide the site, and lead others.
- Proficiency with applicable computer systems.
- Authorized to work in the U.S. full-time (no visa sponsorship).
Preferred:
- 5+ years relevant experience; independent issue resolution.
- SAP, MES (PMX), Darwin, TrackWise, Veeva; strong technical writing/communication; root-cause/troubleshooting; attention to detail.
Compensation/benefits:
- Anticipated wage: $115,500–$169,400; eligible for company bonus and comprehensive benefits (e.g., 401(k), medical/dental/vision, flexible spending, life insurance, time off/leave, well-being).
Responsibilities:
- Provide final disposition of finished drug products; guide the site on technical, quality, and compliance issues for batch release and annual product review.
- Ensure adherence to Global/Local Quality requirements and adequate quality systems for Batch Disposition to meet applicable GMP standards.
- Coach/mentor process teams and operations quality; develop capabilities across quality assurance/compliance and device assembly plus wet/dry packaging.
- Support regulatory inspections as a subject matter expert for batch release topics.
- Lead safety initiatives and support all HSE Corporate and Site goals.
- Own/serve as SME for change controls, deviations, process validation, and other quality items tied to batch release and annual product review.
- Perform final batch disposition of semi-finished/finished batches (commercial, clinical, non-commercial) for Indianapolis device assembly/packaging.
- Liaison for evaluation/completion of shipments under quarantine.
- Qualify quality representatives for vials, sub-assembly, final assembly, and dry packaging; contribute to execution of APRs.
- Review/approve GMP documents (nonconformances, procedures, protocols, specifications, change controls); lead improvements and support inspections.
- Provide technical leadership for major/significant deviations and investigations.
Minimum requirements:
- Bachelor’s degree in chemistry/science/engineering/pharmacy.
- Experience supporting pharmaceutical manufacturing or quality.
- Ability to make technical decisions, guide the site, and lead others.
- Proficiency with applicable computer systems.
- Authorized to work in the U.S. full-time (no visa sponsorship).
Preferred:
- 5+ years relevant experience; independent issue resolution.
- SAP, MES (PMX), Darwin, TrackWise, Veeva; strong technical writing/communication; root-cause/troubleshooting; attention to detail.
Compensation/benefits:
- Anticipated wage: $115,500–$169,400; eligible for company bonus and comprehensive benefits (e.g., 401(k), medical/dental/vision, flexible spending, life insurance, time off/leave, well-being).