Sr Associate Plant QA
Core
Provide QA guidance and support to production staff, perform quality pack checks, and review batch records for medicines labeled and packed at Amgen Breda.
Role type
Senior Associate Plant Quality Assurance
Builds
Commercial batches of medicines
Domain
Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Batch record review, deviation record review, finished product checks, GMP knowledge, GDP knowledge, GCP knowledge, manufacturing process knowledge
Preferred skills
None stated
Technologies
None stated
Responsibilities
Provide daily guidance to production staff on SOP compliance, act as first point of contact for quality queries during packaging/labeling, review and approve batch production record data entries, perform finished product checks during production runs, compile and review batch records for disposition, review and approve deviation records
Seniority
Senior, hands-on IC