Senior Specialist, Field Quality QA Operations
Core
Ensuring GMP compliance and quality oversight in day-to-day pharmaceutical manufacturing operations by reviewing batch records and conducting floor inspections.
Role type
Senior Field Quality QA Specialist (Manufacturing)
Builds
Pharmaceutical products (bulk and finished goods) in compliance with cGMP regulations
Domain
Pharmaceutical manufacturing / Biotechnology
Required skills
GMP compliance, Batch record review, Manufacturing operations knowledge, cGMP regulations (US/EU), 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 (MBRs) for product release, Perform real-time on-the-floor exceptions reviews and logbook checks, Conduct GMP area walkthroughs and readiness reviews, Support return-to-service (RTS) walkthroughs, Investigate and resolve manufacturing issues, Author and revise quality SOPs
Seniority
Senior, hands-on IC
