The Quality Assurance Specialist I or 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.

• Review and approve validation plans, User Requirement Specifications (URS), protocols (IQ/OQ/PQ), and summary reports for equipment and systems.

• Maintain oversight of the qualified and validated state of Facility, Equipment, Utility , and computer systems through periodic review, requalification, deviation review, and change management.

• Create and manage qualification and validation project schedules.

Facility, Equipment, and Utility Oversight

• Support onboarding of new Facility, Equipment, and Utility assets by approving initial release requirements and defining quality expectations for lifecycle management.

• Provide QA oversight for the calibration and maintenance programs to ensure ongoing GMP compliance and operational readiness.

• Review and approve work plans including procedure, test points, tolerances, and acceptance criteria.

• Review and approve asset removal, return-to-service activities, and associated quality documentation.

• Review and approve on-demand work orders for unplanned events and repairs.

Quality Systems:

• Review and approve Standard Operating Procedures related to Facility, Equipment, Utility, and Computer System operation and maintenance.

• Review and approve change controls, deviations, and Corrective and Preventive Actions (CAPAs) related to Facility, Equipment, Utility , and Computer Systems.

KNOWLEDGE SKILLS AND ABILITIES:

• Understanding of requirements and expectations for compliant Facility, Equipment, and Utility programs including commissioning/qualification, calibration, and maintenance.
• Ability to work effectively both independently and cross-functionally.
• Fast learner, adaptable, and has the desire and ability to work in a fast-paced, start-up environment.