Senior Specialist, Field Quality QA Operations
Core
Senior Field QA Specialist ensuring GMP compliance and quality oversight in day-to-day manufacturing operations.
Role type
Senior IC Quality Assurance Specialist (Manufacturing)
Builds
Manufacturing batch records, GMP area readiness, and audit preparedness for pharmaceutical production.
Domain
Pharmaceutical manufacturing / cGMP compliance
Required skills
GMP compliance, batch record review, manufacturing operations knowledge, deviation investigation, SOP authoring, area inspections
Preferred skills
Biotech bulk/finished product manufacturing knowledge, analytical testing knowledge, electronic batch record systems (DeltaV)
Responsibilities
Review manufacturing batch records for product release, perform GMP area walkthroughs, support return-to-service walkthroughs, investigate and resolve manufacturing issues, author and revise quality SOPs, conduct proactive area inspections
Seniority
Senior, hands-on IC
