Specialist, Quality Assurance Validation

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.
• 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.

Prior Experience

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