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Quality Associate

Job in Watertown, Middlesex County, Massachusetts, 02472, USA
Listing for: ClinLab Solutions Group
Full Time position
Listed on 2025-12-31
Job specializations:
  • Quality Assurance - QA/QC
Job Description & How to Apply Below

We are seeking a Quality Associate to support GMP operations during a key development phase. This role focuses on GMP documentation, batch record review, assay qualification support, and cleanroom manufacturing verification. The position is quality-focused and does not involve hands‑on manufacturing.

Key Responsibilities
  • Review and verify GMP batch records and manufacturing documentation
  • Assist with assay qualification support, including:
    Cell‑based assays (imaging, cell count, viability)
  • Support qPCR assay documentation and data review
  • Apply LOD / LOQ concepts to qualification documentation
  • Support controlled documentation within GMP/QA systems
  • Assist with equipment maintenance scheduling, as needed
Qualifications
  • 1–2 years of QA experience in a GMP environment
  • Hands‑on experience with batch record review (required)
  • Familiarity with GMP documentation systems
  • Experience supporting assay qualification activities
Seniority level

Associate

Employment type

Contract

Job function

Quality Assurance

Industries

Biotechnology Research and Staffing and Recruiting

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Position Requirements
10+ Years work experience
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