Specialist, Quality Assurance Validation

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.
• 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.

REQUIRED EDUCATION AND EXPERIENCE:

• 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,

PREFERRED 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.

PHYSICAL REQUIREMENTS:

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

SHIFT WORK, WEEKEND WORK AND HOLIDAY COVERAGE:

• 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 as possible.