Technical skills
Data analysisSRETechnical writing
About this role
Keep a GMP quality control lab running on weekends at a leading biotechnology company in Norton, Massachusetts. You will perform analytical testing, review data and support method transfers that take products from development through commercialization.
What you'll do
- Perform routine and non-routine HPLC/UPLC and/or microbiological assays for raw materials, in-process samples, product release and stability studies following SOPs.
- Support weekend lab operations, including raw material processes, environmental monitoring and in-process testing.
- Review data on time and qualify as a data reviewer.
- Support method transfers, qualification/validation, verification and implementation.
- Maintain lab equipment, inventory, reagents and sample prep; keep training records current.
- Update controlled documents (SOPs, work instructions, test methods) and support investigations, data trending, audits and inspection readiness.
Requirements
- B.S. in Chemistry, Biology, Biochemistry or a related field.
- 4–8 years of GMP quality control experience in pharma/biotech.
- Hands-on HPLC/UPLC testing experience.
- Method transfer/implementation experience; understanding of method lifecycle management preferred.
- Knowledge of GMP, GLP and ICH requirements.
- LabWare LIMS, Excel, Word and PowerPoint preferred.
- Strong technical writing, data analysis and communication skills.
- Available for a weekend schedule (Friday–Monday).
Benefits
- Contract: 12 months (through September 2027), with possible extension
- Shift: Weekend first shift, Friday–Monday, 4 x 10 hours (initial Monday–Friday training)