Temporary Quality Assurance Specialist – Cell Therapy
Core
Temporary Quality Assurance Specialist ensuring compliance, hosting audits, and managing batch documentation for Cell Therapy operations.
Role type
Senior IC Quality Assurance Specialist (GMP)
Builds
Compliant batch releases and robust Quality Management Systems for Cell Therapy products
Domain
Biopharmaceuticals / Cell Therapy / GMP Manufacturing
Required skills
GMP compliance, audit hosting, batch documentation review, CAPA management, SOP development, deviation investigation, change control review, electronic QMS usage
Preferred skills
Cell Therapy experience, biologics experience, Veeva QMS experience
Technologies
Veeva, electronic QMS
Responsibilities
Host Health authority audits and inspections, review and approve batch documentation for QP certification, investigate deviations and manage CAPAs, write and update SOPs and Quality procedures, conduct self-inspections, coordinate audit responses
Seniority
Mid-Senior, hands-on IC