QC Biochemists
Core
Execute quality control testing (receipt, in-process, finished, stability) and analytical method validation in a pharmaceutical manufacturing environment.
Role type
Quality Control Biochemist (IC)
Builds
Pharmaceutical products and validated analytical methods
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
Analytical chemistry, microbiology, GMP/GLP compliance, analytical method validation, laboratory instrumentation operation, incident investigation (OOS/CAPA), procedure authoring, data trending, LIMS management
Preferred skills
Technical transfer experience, pharmacopeial method qualification, cross-functional collaboration
Technologies
LIMS, laboratory instrumentation
Responsibilities
Perform product testing and trend analysis; validate and transfer analytical methods; operate and troubleshoot lab instruments; author and update lab procedures; manage incident reports, non-conformances, and change controls; train staff on biochemical testing processes; represent QC in cross-functional meetings regarding microbial quality control.
Seniority
Mid-level, hands-on IC