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QA Lead, API External Manufacturing
Job summary
A leading global healthcare company is seeking an API EM Quality Assurance Associate based in Prince Edward Island, Canada. The role involves ensuring all batches meet specifications and comply with regulatory commitments. Candidates must have a Bachelor’s in a relevant science field and possess GMP manufacturing experience. Skills in quality oversight, communication, and the ability to influence diverse groups are essential. The position requires onsite work three days a week and some travel to Indianapolis, Indiana.
Qualifications
- Bachelor’s of Science in Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
- Previous GMP manufacturing knowledge and/or experience in API or finished product manufacturing, QC, QA or Engineering.
Responsibilities
- Serve as a liaison between CMs and Lilly.
- Provide quality oversight of CMs.
- Escalate quality issues at CMs to Lilly QA management.
- Participate in regulatory inspection preparations.
- Evaluate and disposition API batches.
Skills
Education
Tools
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.