cGMP Quality Control (QC) Specialist
Core
Design, develop, evaluate, and implement quality control testing, assays, and procedures for biologics and cell/gene therapy products in a cGMP facility.
Role type
cGMP Quality Control Specialist
Builds
High-quality pharmaceuticals and biopharmaceuticals for patient application
Domain
Biologics and cell/gene therapy manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, batch release testing, aseptic techniques, clean room operations, SOP development, equipment operation (cell counters, bioreactors, centrifuges, biosafety cabinets), problem-solving, staff supervision
Preferred skills
Master's degree in biotechnology/life sciences, 5+ years experience in cellular/biological manufacturing
Technologies
cell counters, bioreactors, centrifuges, biological safety cabinets
Responsibilities
Perform cGMP batch release testing; write and review SOPs, batch records, and equipment qualification reports; operate instrumentation for cell therapy manufacturing; verify facility operations and troubleshoot issues; supervise junior staff; maintain confidentiality and follow aseptic techniques in clean rooms; improve QC testing methods
Seniority
Mid-level, hands-on IC with supervisory duties