What are the responsibilities and job description for the Quality Control Specialist position at Tekhawks LLC?
Position: QC SpecialistLocation: Norwood, MA – onsiteDuration: 6 months - Long term projectJob Details:· 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. Preferred:· 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
Salary : $35 - $42