QA Specialist, IAPI (R2-R3) — GMP & Compliance
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Benefits offered by this job
Job summary
Lilly in Indianapolis, IN seeks a Representative - QA - IAPI to provide quality support to API operations manufacturing and laboratory areas and to ensure robust quality systems and GMP compliance.
The position requires a Bachelor's degree in Chemical Engineering, Biomedical Engineering, Pharmacology or related field and 2 years of experience with cGMPs and quality systems. Must support 24 hour/day operations. #LI-DNI
Qualifications
- Bachelor's degree or higher in a scientific field related to chemical engineering, biomedical engineering, pharmacology or similar.
- 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 with statistical tools and analysis.
- Experience in Deviation Management, Change Management, and Inspection Readiness.
Responsibilities
- Review and approve GMP documentation.
- Contribute to deviation investigations and change control proposals.
- Provide quality guidance across manufacturing, materials, utilities, maintenance, and laboratory operations.
- Maintain quality systems and perform analytical data review.
- Prepare for internal and external regulatory inspections.
- Mentor QA Specialists.
Skills
Education
Tools
Job description
Lilly in Indianapolis, IN seeks a Representative - QA - IAPI to provide quality support to API operations manufacturing and laboratory areas and to ensure robust quality systems and GMP compliance.
The position requires a Bachelor's degree in Chemical Engineering, Biomedical Engineering, Pharmacology or related field and 2 years of experience with cGMPs and quality systems. Must support 24 hour/day operations. #LI-DNI
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