Sr. Associate/Principal Associate - External Manufacturing API Quality Assurance

LI Test Company(2 months ago)

United States, Indianapolis, INOnsiteFull TimeMedior$65,250 - $169,400Quality Assurance

About this role

The API EM Quality Associate supports quality activities with external Contract Manufacturing organizations to ensure manufacturing and release of APIs meet specifications and comply with cGMP and regulatory commitments. The role acts as a quality liaison between Lilly and partners, maintaining oversight of quality agreements, batch documentation, and inspection readiness while collaborating with site teams and QA management.

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Required Skills

Quality Oversight
GMP
Regulatory Compliance
Batch Review
Change Control
Deviation Management
Root Cause Analysis
Statistical Analysis
Document Review
Communication

+2 more

Qualifications

BS in a Science-Related Field (Pharmacy, Chemistry, Biological Sciences)

About LI Test Company

lilly.com

Eli Lilly and Company is a global biopharmaceutical company headquartered in Indianapolis, Indiana. It discovers, develops, manufactures and commercializes prescription medicines across therapeutic areas including diabetes, oncology, immunology, neuroscience and pain, and has a longstanding history in insulin and other major drug discoveries. Lilly invests heavily in research and clinical development and partners with biotech, academic institutions, and industry collaborators to advance biologics, small molecules, and precision medicines. The company operates global manufacturing and commercial networks and provides patient-support programs to improve access to its therapies.

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