Senior Quality Assurance Specialist

Senior Quality Assurance Specialist

The Terra Power Isotopes (TPI) division has been established to pursue medical isotopes development--advancing nuclear science for significant human health benefits. We seek to support revolutionary radiotherapies for treatments of various cancers through the supply of radioisotopes. Terra Power currently has unique access to a supply of thorium for the long-term production of actinium-225 in the growing alpha therapy market and intends to expand into other nuclear related medical treatments.

The Terra Power Isotopes program is an integral part of the Washington State based Terra Power team, a company working to raise living standards globally. In 2006, the company originated with Bill Gates and a group of like-minded visionaries who evaluated the fundamental challenges to raising living standards around the world. Terra Powers mission is to be a world leader in new nuclear technologies, while developing innovators and future leaders in the nuclear field.

TPI is seeking to hire highly motivated and forward-thinking professionals who are interested in focusing on advanced radiopharmaceutical applications and influencing change within nuclear medicine. Terra Power is an Equal Opportunity Employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law.

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.

• 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.

• Bachelors 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…