Quality Control Chemist
Core
Perform analytical testing in a GMP-regulated Quality Control laboratory to support batch release, stability, and raw material testing for commercial combination drug-device products.
Role type
Quality Control Chemist (Analytical)
Builds
Certificates of Analysis (CoA), technical reports, and compliant laboratory documentation for vascular disease treatment products.
Domain
Healthcare / Pharmaceutical Manufacturing / Quality Control
Required skills
HPLC/UPLC analysis, dissolution testing, GMP compliance, data integrity, analytical instrumentation operation, technical writing, laboratory documentation
Preferred skills
Batch release and stability testing, USP/EP compendial methods, ICH guidelines, OOS/OOT investigations, method validation, LIMS experience, FTIR/GC/Karl Fischer techniques
Technologies
HPLC, GC, Dissolution apparatus, FTIR, UV-Vis, Karl Fischer titration, LIMS, Microsoft 365
Responsibilities
Operate analytical instrumentation for drug-related attributes; evaluate results against specifications; maintain GMP-compliant records; support OOS/OOT investigations; perform routine instrument maintenance and calibration.
Seniority
Mid-level, hands-on IC