Title: QC Specialist – Raw Materials (Bioassay / cGMP / Biotech)
Location: Norwood, MA (Onsite)
Shift: 2:00 PM – 10:00 PM (Monday–Friday)
Employment Type: Contract (6+ Months)
Status: Accepting Candidates
About the Role
We are supporting a leading biotech organization seeking a QC Specialist – Raw Materials to support cGMP quality control testing across raw materials, drug substance, and finished products.
This role will focus on bioassay testing, method transfers, and quality systems while working cross-functionally with Manufacturing, Quality Assurance, and Development teams. The ideal candidate will have hands-on experience in cGMP labs, bioassays, and cell-based testing.
Key Responsibilities
QC Testing & Lab Operations
- Perform routine cGMP testing for raw materials, drug substance, and drug product
- Execute and troubleshoot bioassays and analytical methods
- Analyze, review, and trend laboratory data
Method Transfer & Validation
- Support method transfers and qualification activities
- Assist in expanding bioassay lab capabilities
- Participate in method validation and assay performance improvements
Quality Systems & Compliance
- Own and manage quality records (deviations, CAPAs, change controls, investigations)
- Ensure compliance with cGMP documentation and regulatory standards
- Support audits and continuous improvement initiatives
Documentation & Training
- Write and revise SOPs, protocols, and reports
- Train junior analysts on technical methods and lab practices
- Maintain accurate and compliant documentation
Lab Support & Troubleshooting
- Troubleshoot equipment, assay, and process issues
- Maintain lab equipment and ensure proper calibration
- Maintain a safe laboratory working environment
Required Qualifications
- BA/BS degree in a STEM field
- Minimum 2+ years of experience in a cGMP laboratory environment
- Hands-on experience with mammalian cells and cell-based assays
- Experience with ELISA, protein analysis, or in vitro assays
- Strong understanding of cGMP practices and regulatory compliance
- Experience with laboratory instrumentation (pipettes, balances, pH meters, etc.)
Preferred Qualifications
- Experience with method validation/qualification for bioassays
- Knowledge of FDA, EU, and ICH guidelines
- Experience with aseptic techniques and biological safety cabinets
- Experience in technical writing and training
- Strong ability to work in cross-functional environments
Compensation (MA Pay Transparency)
- Estimated hourly range: $30–$37/hr (W2), with flexibility up to $40/hr for highly qualified candidates
- Final rate will depend on experience and interview outcomes
