Specialist, Quality Assurance Validation

Specialist, Quality Assurance Validation

Bothell, Washington, United States

The Quality Assurance Specialist 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.

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.

• 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.
• Excellent communication, emotional intelligence and interpersonal skills.
• Familiar with quality management systems (e.g. deviations, CAPAs, change management).
• Curious and proactive mindset with a continuous improvement orientation.

• Bachelor's degree in life sciences or a related technical discipline with a minimum of 5 years of experience in a GMP biopharmaceutical manufacturing environment or equivalent combination of relevant education, training, and experience.

• Prior experience in a Quality Assurance oversight role for Facility, Equipment, and Utility qualification and management.
• Experience with computer system validation.
• Previous experience using Blue Mountain computerized maintenance management software.
• Experience with cell therapy and/or lentiviral manufacturing operations.
• Experience in commercial manufacturing and post-approval lifecycle management.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. While performing their duties, the employee must be able to do the following:

• Stand and step over a gowning bench (12-24") and aseptically don head-to-toe non-sterile and sterile gowns.

While this position is primarily Monday – Friday, occasional off-shift work, weekend work, and holiday work may be required due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely…