Specialist - QA Shop Floor
Core
Provide quality oversight for routine clinical and commercial cell therapy operations, ensuring adherence to cGMP and supporting quality risk management on the shop floor.
Role type
Specialist, hands-on IC Quality Assurance
Builds
Cell therapy products for patients with serious diseases
Domain
Biotechnology / Cell Therapy Manufacturing
Required skills
cGMP compliance, Good Documentation Practices (GDocP), Data Integrity/ALCOA+, batch record review, deviation management, product disposition, risk-based decision making, SOP and Work Instruction review, manufacturing system proficiency (MES, ERP, Deviation Management, Document Management)
Preferred skills
Experience in regulated environments (pharmaceuticals, biotechnology, cell therapy), Kaizen events, 5S activities, cross-functional gemba
Technologies
MES, ERP (SAP), Infinity, BMSDocs
Responsibilities
Perform real-time review of executed batch records; observe manufacturing operations for cGMP compliance; own and approve operational documents (SOPs, Work Instructions); lead deviation triage and closure; execute continuous improvement initiatives
Seniority
Specialist, hands-on IC