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Product Quality Lead - QA & Compliance Phase I​/II OSD

Job in Waltham, Middlesex County, Massachusetts, 02254, USA
Listing for: Alkermes, Inc.
Full Time position
Listed on 2026-06-26
Job specializations:
  • Quality Assurance - QA/QC
  • Healthcare
Salary/Wage Range or Industry Benchmark: 70000 - 90000 USD Yearly USD 70000.00 90000.00 YEAR
Job Description & How to Apply Below
Position: Product Quality Lead - QA & Compliance for Phase I/II OSD

Alkermes, Inc. in Waltham, MA is seeking a Quality Assurance professional to provide onsite support for Phase I/II oral solid dosage manufacturing. This role focuses on ensuring compliance with FDA/EU cGMP requirements and overseeing the analytical lifecycle, including instrument qualification and method validation.

The ideal candidate will have experience in QA within the pharmaceutical sector, strong analytical skills, and the ability to ensure activities align with internal quality standards. Join a team that values collaboration and compliance.

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