Specialist, QC Separations
Core
Perform release and stability testing for drug substance and drug product samples in a regulated biopharmaceutical laboratory.
Role type
QC Biologics Specialist (Separations)
Builds
Drug product and drug substance release testing, stability testing
Domain
Biopharmaceuticals / Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, HPLC/UPLC operation, data analysis, documentation (ALCOA+), OOS/OOT investigation, SOP management, method lifecycle support
Preferred skills
Empower software experience, regulated biopharmaceutical lab experience
Technologies
HPLC, UPLC, Empower
Responsibilities
Perform release and stability testing for drug substance and drug product samples; Perform routine data analysis and review results; Accurately document all laboratory activities; Identify, investigate, and document Out-of-Specification (OOS) and Out-of-Trend (OOT) events; Support preparation and execution of technical transfer and co-validation activities; Adhere to all site safety, data integrity, and quality policies
Seniority
Mid-level, hands-on IC
