Representative - QA - IAPI (R2-R3)
About The Position
Eli Lilly and Company seeks a Representative - QA - IAPI (R2-R3) to provide quality support to Indianapolis API Operations manufacturing and laboratory areas and to ensure robust quality systems and GMP compliance. Review and approve key GMP documentation, contribute to deviation investigations and change control proposals, and provide quality guidance across manufacturing, materials, utilities, maintenance, and laboratory operations. Maintain quality systems, perform analytical data review, support product and process assessments, and prepare for internal and external regulatory inspections. Participate in customer complaint investigations, stability and analytical data review, and the disposition of API intermediates and raw materials. Contribute to quality system improvement and provide mentoring to QA Specialists.
Requirements
- Bachelor's degree in Chemical Engineering, Biomedical Engineering, Pharmacology or a related scientific field.
- 2 years of academic or employment experience with cGMPs and quality systems.
- 2 years of experience with Quality Assurance, Quality Control, Manufacturing, Engineering, Technical Services, or Regulatory Affairs.
- 1 year of experience with statistical tools and analysis.
- Experience in Deviation Management, Change Management, and Inspection Readiness.
- Must support 24 hour/day operations.
Responsibilities
- Provide quality support to Indianapolis API Operations manufacturing and laboratory areas.
- Ensure robust quality systems and GMP compliance.
- Review and approve key GMP documentation.
- Contribute to deviation investigations and change control proposals.
- Provide quality guidance across manufacturing, materials, utilities, maintenance, and laboratory operations.
- Maintain quality systems.
- Perform analytical data review.
- Support product and process assessments.
- Prepare for internal and external regulatory inspections.
- Participate in customer complaint investigations.
- Participate in stability and analytical data review.
- Participate in the disposition of API intermediates and raw materials.
- Contribute to quality system improvement.
- Provide mentoring to QA Specialists.
Benefits
- company bonus (depending, in part, on company and individual performance)
- company-sponsored 401(k)
- pension
- vacation benefits
- medical benefits
- dental benefits
- vision benefits
- prescription drug benefits
- flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- life insurance
- death benefits
- certain time off and leave of absence benefits
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
