Audit Specialist
Core
Lead QA Technician ensuring product quality and regulatory compliance in pharmaceutical manufacturing operations.
Role type
Lead QA Technician (pharmaceutical manufacturing)
Builds
Life-changing medicines
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
GMP regulations, FDA guidelines, batch record review, deviation investigations, CAPA management, aseptic manufacturing processes, quality documentation systems, regulatory inspections, root cause analysis, clean room operations
Preferred skills
Chemistry, Pharmacy, Biology, Biotechnology, clean room operations, gowning procedures
Technologies
TrackWise, Documentum, Microsoft Office
Responsibilities
Oversee quality of pharmaceutical manufacturing operations, review batch records, investigate deviations, manage CAPA, support regulatory inspections and customer audits, guide and develop team members
Seniority
Senior, hands-on IC
