QC Analyst II
Core
Perform Quality Control assays for product release of cell therapy products, Raw Material Release, and Stability Studies while maintaining data and adhering to cGMP regulations.
Role type
Quality Control Analyst II (Cell Therapy)
Builds
Cell therapy products, raw materials, and stability data
Domain
Biotechnology / Cell Therapy / cGMP Manufacturing
Required skills
biological and cell-based assays, flow cytometry, cGMP compliance, lab equipment operation and troubleshooting, data recording, SOP adherence, spreadsheet/database proficiency
Preferred skills
mentoring and training others, workflow improvement suggestions
Technologies
flow cytometry, specialized lab equipment, spreadsheets, databases
Responsibilities
Perform QC assays for product release, Raw Material Release, and Stability Studies; Record test results and maintain raw data accurately; Identify cGMP breaches and suggest corrective actions; Maintain and troubleshoot basic and specialized lab equipment; Develop subject matter expertise to support less experienced analysts.
Seniority
Mid-level, hands-on IC