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Senior / Principal Associate QA API External Manufacturing at Eli Lilly and Company - ApplyBlast

Senior / Principal Associate QA API External Manufacturing

Eli Lilly and Company

1 month ago

4.0 on Glassdoor

Indianapolis, Indiana, United States

Onsite

Full Time

Senior

0 applicants

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About this role

Eli Lilly and Company is seeking a highly motivated and experienced professional to ensure the quality and compliance of externally manufactured Active Pharmaceutical Ingredients (APIs) in accordance with cGMP regulations and company standards. This role involves significant oversight and collaboration with external manufacturing partners to support new product introductions, technology transfers, and continuous improvement initiatives. The position requires maintaining current knowledge of regulatory requirements and supporting regulatory inspections related to external manufacturing activities.

Responsibilities

Serve as primary Quality Assurance point of contact for external manufacturing sites
Review and approve manufacturing documentation to ensure cGMP compliance
Lead quality audits of external manufacturing partners to assess compliance

Skills

Qualifications

Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, or a related scientific discipline

About Eli Lilly and Company

lilly.com

Headquarters

Indianapolis, Indiana, United States

Company Size

10001+ employees

Founded

1876

View Profile

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.