QC Scientist - Physiochemistry & Raw Material
Core
Perform and provide technical oversight of raw material sampling, testing, and release activities in accordance with GMP requirements.
Role type
QC Scientist (Physiochemistry & Raw Material)
Builds
Raw material quality control data and release decisions for biopharmaceutical products
Domain
Biopharmaceutical manufacturing / Quality Control
Required skills
physiochemistry testing techniques, laboratory instrumentation operation (pH, conductivity, osmolality, TOC), analytical data interpretation, GMP compliance, risk assessment tools (FMEA, fishbone, HAZOP), quality system management (Change Control, Deviations, CAPA, OOS/OOT), data integrity (ALCOA+)
Preferred skills
bio-pharmaceutical process knowledge, aseptic techniques, Smartsheets
Technologies
pH meters, conductivity meters, osmometers, TOC analyzers, Smartsheets, Microsoft Excel
Responsibilities
Perform raw material sampling, testing, and release; execute analytical testing against approved procedures; review and approve test records; identify and report non-conformances and OOS/UR results; support risk assessment tools application; lead Quality System activities (Change Control, Deviations, CAPA, OOS/OOT)
Seniority
Mid-level, hands-on IC