Senior Specialist, Field Quality QA Operations
Core
Ensuring GMP compliance and quality oversight in day-to-day manufacturing operations through batch record review, on-floor inspections, and deviation resolution.
Role type
Senior Field Quality Specialist (Manufacturing)
Builds
Pharmaceutical/medical device manufacturing batches compliant with cGMP regulations
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
GMP compliance, batch record review, manufacturing deviation investigation, SOP authoring, area inspection, regulatory knowledge (US/EU cGMP)
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 and inspection readiness reviews, investigate and resolve manufacturing issues, author and revise quality SOPs, train new team members on quality tasks
Seniority
Senior, hands-on IC