Analyst 1, Analytical (QC)
Core
Perform testing and analysis of final products, in-process, and raw material samples to support business requirements in a biologics manufacturing environment.
Role type
QC Analyst (Analytical)
Builds
High-quality biologics and cell therapies
Domain
Life Sciences / Biologics Manufacturing
Required skills
Spectroscopy, Chromatography (HPLC), Protein Concentration methods, Potency methods, Physiochemical methods, cGMP compliance, Equipment troubleshooting, Method validation, Assay trend analysis
Preferred skills
Lab experience in biotech or medically related field, Problem solving, Analytical skills
Technologies
HPLC, Spectroscopy equipment, QC standards and reagents
Responsibilities
Prioritize and perform testing/analysis in a timely manner, Analyze samples according to SOPs and Test Methods, Document and review results in accordance with cGMP, Solve analytical method problems and troubleshoot equipment, Participate in method transfers and validation, Qualify equipment and select QC equipment/standards/reagents, Conduct assay trend analysis and update documents, Provide general lab support including housekeeping and inventory management
