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Manufacturing Support
Job in
Watertown, Middlesex County, Massachusetts, 02472, USA
Listed on 2026-01-12
Listing for:
Meet Life Sciences
Full Time
position Listed on 2026-01-12
Job specializations:
-
Manufacturing / Production
Pharmaceutical Manufacturing, Validation Engineer
Job Description & How to Apply Below
Manufacturing Support Associate provides hands‑on support to GMP manufacturing operations within a CDMO environment. This role is responsible for owning and investigating deviations, performing detailed manufacturing batch record (M ) reviews, and ensuring documentation accuracy and compliance. The associate partners closely with manufacturing, quality, and technical teams to maintain high-quality standards and support continuous improvement initiatives.
Responsibilities- Lead and execute deviation investigations, including root cause analysis and deviation report writing.
- Perform comprehensive M reviews to ensure accuracy, completeness, and compliance with GMP requirements.
- Support documentation activities such as logbook reviews, corrections, and updates to manufacturing records.
- Collaborate with manufacturing teams to gather data, understand workflow issues, and drive timely deviation closure.
- Assist in implementing corrective and preventive actions (CAPAs) and support process improvements.
- Ensure adherence to GMP guidelines and maintain audit‑ready documentation practices.
- Participate in cross‑functional meetings to support production activities and resolve documentation‑related issues.
- 3–5 years of experience in a GMP manufacturing environment (biotech, pharma, or CDMO preferred).
- Strong, hands‑on experience owning and writing deviations, including root cause and impact assessments.
- Experience reviewing manufacturing batch records and supporting related documentation.
- Working knowledge of GMP regulations and manufacturing operations.
- Associate
- Contract
- Manufacturing
- Pharmaceutical Manufacturing
Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment.
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