Product Quality Lead
Job in
Waltham, Middlesex County, Massachusetts, 02254, USA
Listed on 2026-06-26
Listing for:
Alkermes, Inc.
Full Time
position Listed on 2026-06-26
Job specializations:
-
Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, Production QC/QA
Job Description & How to Apply Below
POSITION SUMMARY:
Provide onsite Quality Assurance (QA) support for the establishment and operation of Phase I/II oral solid dosage (OSD) manufacturing and analytical activities, with primary focus on analytical lifecycle oversight (instrument qualification, method validation, stability, and data review), cleaning validation for manufacturing equipment, and QA support batch manufacturing. Ensure all activities are executed in full compliance with FDA/EU cGMP requirements and internal quality standards, and support batch disposition through robust data review and cross-functional collaboration.
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