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About the Role
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 CAPA...
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