Title: Sr. QC Analyst
Location: Bedford, MA (Hyrbid)
A pharmaceutical company specializing in gene therapy is looking to build out their team as they continue to grow. They are looking for a Sr. QC Analyst to specialize in lab investigations, deviations, change controls, and risk assessments.
- Quaification, transfer, and validation of analytical methods (PCR, ELISA, etc.)
- Write and execute SOPs related to QC method transfer, validation, and verification activities
- Collaborate on Quality systems (CAPA, OOS/OOT, change control)
- Assist with data trending of assay controls
- Support analytical method troubleshooting
- 3 years experience within biologics
- Hands on experience with analytical test methods
- Experience writing SOPs
- Exposure to lab investigations (OOS/OOT, deviations, CAPAs, change controls, risk assessment)
If you would like to hear more, please don't hesitate to apply!