QA Specialist II
Core
Ensuring compliance with regulatory requirements and internal procedures for manufacturing and laboratory processes in a biopharmaceutical setting.
Role type
Quality Assurance Specialist
Builds
High quality cell therapy products compliant with GMP/GLPs
Domain
Biopharmaceuticals / Cell Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/GLPs knowledge, deviation and CAPA management, root cause analysis, technical writing, regulatory compliance
Preferred skills
Biopharmaceutical industry experience
Technologies
Microsoft Office
Responsibilities
Perform QA activities to ensure regulatory compliance, maintain GMP/GLP programs, support escalations and provide front-line QA support, review and approve deviations and CAPAs, conduct investigations, develop SOPs, coordinate audits and inspections, mentor junior staff, contribute to cross-functional QA projects
Seniority
Mid-level, hands-on IC