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Quality Control Specialist
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-03-06
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-03-06
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst -
Healthcare
Data Scientist
Job Description & How to Apply Below
- The Quality Control Specialist will support cGMP routine testing of raw materials, drug substances, and finished products within a manufacturing environment and affiliated contract organizations.
- This on-site role is responsible for executing and troubleshooting analytical and bioassay methods, leading method transfers and qualification activities, and ensuring compliance with cGMP and regulatory standards.
- The position serves as a bioassay subject matter expert, collaborating cross-functionally with Manufacturing, Quality Assurance, and Development, while supporting routine testing, special projects, audit readiness, and continuous improvement initiatives.
- Additional responsibilities include authoring and revising SOPs, protocols, and reports; reviewing, analyzing, and trending data; managing quality records such as investigations, change controls, and CAPAs; training and mentoring analysts; and maintaining a safe laboratory environment.
- The ideal candidate holds a BA/BS degree in a STEM field with at least five years of hands-on experience in a cGMP laboratory, including expertise in mammalian cell culture, cell-based assays, ELISA, protein analysis, and IVRPE.
- Experience in method validation and qualification of cell-based or protein assays, along with a strong Right-First-Time execution mindset, is highly preferred.
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