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Quality Control Specialist

Katalyst Healthcares & Life Sciences

Boston, MA

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JOB DETAILS
SKILLS
Analysis Skills, Assays, Biological Assay, Cell Cultures, Change Control, Continuous Improvement, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Analysis, Identify Issues, Maintain Compliance, Manufacturing, Materials Testing, Mentoring, Quality Assurance, Quality Control, Quality Management, Records Management, Regulatory Compliance, Safety/Work Safety, Standard Operating Procedures (SOP), Testing, Trend Analysis
LOCATION
Boston, MA
POSTED
30+ days ago
Roles & Responsibilities:
  • 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.

About the Company

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Katalyst Healthcares & Life Sciences

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