Senior Quality Assurance Specialist

Senior Quality Assurance Specialist

Terra Power Isotopes is seeking an experienced Senior Quality Assurance Specialist to support Ac-225 production at the Everett, WA manufacturing facility.

The successful candidate will have experience in a quality assurance role with focus on ensuring compliance with Good Manufacturing Practices (GMP), regulatory guidelines (FDA Title 21 CFR 210/211 and ICH Guidelines), radiation safety, and company policies. The Senior Quality Assurance Specialist will be a key contributor in designing quality systems to support cGMP manufacturing activities, including leading project teams to meet key quality initiatives.

The Senior Quality Assurance Specialist will also support the quality assurance activities including batch and material disposition, deviations, CAPA, change controls, authoring procedures and policies, supplier qualification and performance monitoring, audits, and system implementation. The position requires excellent judgement and discretion in balancing compliance and business resolutions. The Senior Quality Specialist will report to the Manager, Quality Assurance and work closely with a multidisciplinary team including Operations, Quality Control, Engineering, R&D, Procurement, Project Management, and Commercial Services teams to achieve company objectives.

Responsibilities:

• Lead and contribute to quality-driven project teams to support key organizational initiatives.
• Optimize current site policies and procedures to support cGMP implementation.
• Review batch records, Certificates of Analysis, and supporting documentation to accurately and efficiently disposition product batches.
• Review and approval of quality documentation, including deviations, change controls and CAPA, and complaints.
• Provide Quality Assurance support for routine production activities at the Everett Laboratory.
• Lead and participate in internal, supplier, and customer audits, and drive timely resolution of audit findings.
• Support the supplier qualification program by verifying compliance with quality requirements and monitoring performance of critical suppliers and service providers.
• Support implementation of Quality Management Systems.
• Support development processes for validation/qualification of equipment, facility, and/or manufacturing processes.
• Ensure data integrity compliance across quality systems, including adherence to ALCOA+ principles and 21 CFR Part 11 requirements.
• Balance quality and compliance needs with safety requirements, including radiation safety.
• Communicate quality expectations and objectives across the organization to promote a strong quality culture.
• Deliver comprehensive quality-related training and serve as a subject-matter resource for colleagues.
• Perform additional duties as required to support Quality Assurance operations.

Key

Qualifications and Skills:

• Bachelor's degree in life sciences discipline, engineering, or a related field (or equivalent qualification through experience).
• 8+ years' industry experience in a regulated production environment (e.g., ISO 9001, cGMP pharmaceutical or radiopharmaceutical industries), including 3+ years of prior experience in a Quality Assurance role.
• Certification in a pharmaceutical Quality-related discipline, Lean Six Sigma or project management training/certification is a plus.
• Demonstrated experience working within Quality Systems.
• Strong working knowledge of quality principles, with proven success in managing complex projects and a wide range of responsibilities.
• Experience working within a quality program compliant to FDA/cGMP requirements Title 21 CFR 210/211 and ICH Guidance. Experience in a production radiopharmaceutical facility is preferred.
• Strong attention to detail, with the ability to interpret federal regulations, guidance and standards. Ability to incorporate relevant requirements into TPI documentation and provide guidance to personnel regarding compliance.
• Must demonstrate flexibility in adjusting to changing priorities and schedules in a dynamic environment. Occasional evening or weekend work might be required to support production operations or project deliverables.
• Strong interpersonal skills with demonstrated ability to…