Senior Quality Assurance Specialist

About the role

TerraPower 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.

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.
• 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.

Qualifications

• 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.
• Strong interpersonal skills with demonstrated ability to lead internal and external cross-functional teams and drive accountability.
• Excellent written and verbal communication skills, including technical writing proficiency and executive-level reporting abilities.

Skills

The successful candidate will possess a high degree of trust and integrity, communicate openly, and display respect while fostering teamwork.

Benefits

• Competitive Compensation
• Salary, eligible to participate in discretionary short-term incentive payments
• Comprehensive Medical and Wellness Benefits
• Medical
• Vision
• Dental
• Life and Disability
• Gender Affirmation Benefits
• Parental Leave
• 401k Plan
• Generous Paid Time Off (PTO)
• 21 days of annually accrued PTO
• Generous Holiday Schedule
• 10 paid holidays
• Relocation Assistance
• Professional and Educational Support Opportunities

Pay

Salary Range: $124,114 - $161,187. We typically place offers in the lower to middle portion of the range to maintain internal equity and allow room for growth. Any salary offered within the posted salary band is based on market data and commensurate with the selected individual's qualifications experience. This range is specific to Washington State.

Schedule

Full-time. Occasional evening or weekend work might be required to support production operations or project deliverables. Travel required 10-30%.