The Quality Assurance Specialist II provides QA oversight for Facility, Equipment, Utility (FEU), and Computer System (CS) programs in a cell therapy manufacturing environment, with accountability for review, approval, escalation, and lifecycle compliance activities that support GMP readiness and sustained operational control.

This role serves as the Quality representative on cross-functional project teams and ensures Facility, Equipment, Utility, and Computer System activities are planned, executed, documented, and maintained in compliance with GMP requirements while supporting clinical and commercial operating timelines.

KEY ROLES AND RESPONSIBILITIES:

Commissioning, Qualification, and Validation

• Provide QA compliance oversight for Facility, Equipment, Utility, and Computer System qualification and validation projects.