Quality Assurance Engineer III (temporary 12 months)
Core
Ensures manufacturing quality compliance, leads investigations, and manages validation protocols for pharmaceutical production.
Role type
Senior Manufacturing Quality Assurance Engineer
Builds
Pharmaceutical manufacturing processes and quality systems
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, deviation resolution, CAPA management, validation protocol authoring, statistical quality programs, FMEA development, batch release, SOP approval, product impact analysis
Preferred skills
Risk analysis, process monitoring systems, liaison with plant departments
Technologies
None explicitly stated
Responsibilities
Lead and participate in investigations of plant events; approve standard operating procedures and calibration requests; audit commissioning and validation documentation; develop product quality plans and specifications; implement statistical quality programs; perform batch release for specific U.S. sites.
Seniority
Senior, hands-on IC
