Specialist, QA Operations Shopfloor
Core
On-site QA specialist ensuring compliance with cGMP and approved procedures across manufacturing, QC, warehouse, and maintenance operations in a cell therapy facility.
Role type
Specialist, QA Operations Shopfloor
Builds
Cell therapy manufacturing products for patients with blood cancer
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, deviation assessment, aseptic technique monitoring, operational verification, record review, cross-functional communication, problem-solving
Preferred skills
FDA/EMA regulations knowledge, Quality Management Systems (QMS), Manufacturing Execution Systems (MES), ERP systems
Technologies
MES, ERP, MS Office
Responsibilities
Provide on-the-floor quality oversight to manufacturing, QC, warehouse, and maintenance; identify and document departures from procedures; assess discrepancies and approve deviations; observe clean room behaviors and aseptic techniques; perform area walkthroughs; review manufacturing/testing records; support internal/external inspections.
Seniority
Specialist, entry-level to mid-level (0-2 years experience)