Senior Specialist, Field Quality QA Operations
Core
Ensuring GMP compliance and quality oversight in day-to-day biopharmaceutical manufacturing operations through real-time floor support, batch record review, and area inspections.
Role type
Senior Field Quality QA Specialist (Manufacturing)
Builds
Ensures production readiness and regulatory compliance for biopharmaceutical manufacturing batches.
Domain
Biopharmaceutical manufacturing / cGMP compliance
Deliverable
physical/clinical work
Required skills
cGMP regulations knowledge, batch record review, GMP area walkthroughs, deviation investigation, SOP authoring/review, electronic/paper batch record systems, DeltaV systems
Preferred skills
Biotech bulk and finished product manufacturing knowledge, analytical testing knowledge, electronic systems for lab test results and inventory management
Responsibilities
Review manufacturing batch records for product release compliance, perform real-time on-the-floor exception reviews and logbook checks, conduct GMP area walkthroughs and readiness reviews, support return-to-service walkthroughs, investigate and resolve manufacturing issues, author and revise quality SOPs
Seniority
Senior, hands-on IC
