Quality Assurance Specialist
Core
Oversee quality assurance development and execute QA activities for clinical Good Manufacturing Practices (GMP) of bioprinted cell therapies.
Role type
Quality Assurance Specialist (GMP)
Builds
Bioprinted cell therapies
Domain
Biotechnology / Regenerative Medicine / Bioprinting
Required skills
GMP quality program development, FDA/EMEA regulatory knowledge, document control, SOP creation, root cause analysis, risk assessment, vendor qualification, batch record review, CMC equipment qualification
Preferred skills
Medical device regulations experience, collaboration with R&D/CMC/QC teams
Technologies
QMS, GMP documentation systems
Responsibilities
Develop internal QA processes and Quality Management System (QMS), maintain document control, create and review SOPs and policies, review study protocols and data for completeness, conduct root cause analysis and corrective actions, review batch records for compliance, support vendor qualification, assist in critical raw material specifications and equipment qualification, collaborate with R&D to embed quality standards.
Seniority
Mid-Senior, hands-on IC
