Senior Specialist, QA Operations Shopfloor
Core
Ensuring manufacturing compliance and performing real-time quality review of batch records and documentation at a Cell Therapy Facility.
Role type
Senior Specialist, QA Operations Shopfloor
Builds
Commercial manufacturing of multi-product Cell Therapy
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, batch record review, deviation and investigation management, CAPA management, material disposition, change control, product complaints, quality risk management, GMP warehousing knowledge
Preferred skills
FDA/EMA regulations knowledge, cell therapy manufacturing experience, manufacturing site experience, continuous improvement methodologies
Technologies
None explicitly stated
Responsibilities
Perform QA shopfloor activities, ensure manufacturing compliance with procedures and batch records, review manufacturing shopfloor documentation, resolve manufacturing issues with operations, generate technical conclusions from investigations
Seniority
Senior, hands-on IC
