Specialist, QA Operations Shopfloor
Core
Ensures compliance with cGMP policies and standards across manufacturing, QC, warehouse, and maintenance operations on the shopfloor.
Role type
Specialist, QA Operations Shopfloor
Builds
Commercial manufacturing of cell therapy products
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 management, aseptic technique observation, 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 quality oversight to manufacturing, QC, warehouse, and maintenance; identify and escalate procedure departures; assess and approve deviations; perform area walkthroughs; review manufacturing/testing records; support internal/external inspections.
Seniority
Entry-level to Junior (0-2 years experience)