Title: QC Specialist – Bioassay
Location: Greater Norwood Area, MA (Onsite)
Shift: 2PM-10PM M-F
Employment Type: Contract
Status: Accepting Candidates
About the role
Support cGMP QC bioassay testing across raw materials, drug substance, and finished products in a manufacturing environment. This role partners cross-functionally with QA, Manufacturing, and Development while contributing to method transfers and lab expansion activities.
Key Responsibilities
- Execute and troubleshoot cell-based bioassays, ELISA, and protein analysis
- Support method transfer, validation, and qualification activities
- Own and manage quality records (CAPA, deviations, change controls, investigations)
- Write/revise SOPs, protocols, and technical reports
- Perform aseptic techniques and routine lab operations in a cGMP environment
- Train analysts and collaborate across QA, Manufacturing, and Development teams
Qualifications
- BA/BS degree with 2+ years in a cGMP laboratory
- Hands-on experience with mammalian cell culture and cell-based assays
- Strong experience in ELISA and protein analysis
- Experience with method validation/qualification
- Knowledge of FDA, EU, ICH guidelines and GMP documentation
- Experience with technical writing and training
Compensation (MA Pay Transparency):
- Estimated hourly range: $30–$40/hr (W-2)
- Final rate within this range will be based on skills, experience, and interview results.
