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
Biopharmaceuticals / Pharmaceutical Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
physiochemistry testing techniques, laboratory instrumentation operation (pH, conductivity, osmolality, TOC), analytical data interpretation, GMP compliance, risk assessment tools (FMEA, fishbone, HAZOP), data integrity (ALCOA+), change control, deviation management, CAPA, OOS/OOT investigation
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 and interpret analytical tests against approved procedures; review and approve test records; identify and report non-conformances and OOS/UR results; support risk assessment tools and Quality System activities (Change Control, Deviations, CAPA, OOS/OOT)
Seniority
Mid-level, hands-on IC