TerraPower
Senior Quality Assurance Specialist
$124K–$161K
Everett, WA · Senior · Full-time · Posted Aug 12, 2026
- Experience
- 8+ years in a regulated production environment, including 3+ years of prior experience in a Quality Assurance role.
- Education
- Bachelor’s degree in life sciences discipline, engineering, or a related field (or equivalent qualification through experience).
- Visa sponsorship
- Applicants who are foreign nationals (other than asylees, refugees, or lawful permanent residents) are evaluated under U.S. Government export control requirements. Applicants are asked to identify whether they are a U.S. citizen or national, asylee, refugee, or lawful permanent resident; authorization timing varies, and foreign nationals from some countries may not be considered if timely approval is impracticable.
About the job
Supports Ac-225 production at TerraPower Isotopes’ Everett facility by designing and operating quality systems, ensuring GMP and regulatory compliance, and providing quality assurance for manufacturing activities.
What you'll do
- Lead quality-focused projects and improve site policies and procedures for cGMP implementation.
- Review and disposition batches and quality records, including deviations, change controls, CAPA, and complaints.
- Support audits, supplier qualification, quality systems, validation, data integrity, radiation safety, and quality training.
What they ask for
- Bachelor’s degree in life sciences, engineering, or a related field, or equivalent qualification through experience.
- 8+ years’ industry experience in a regulated production environment, including 3+ years in a Quality Assurance role.
- Experience working within Quality Systems and a quality program compliant with FDA/cGMP requirements, Title 21 CFR 210/211, and ICH Guidance.
- Strong knowledge of quality principles and ability to lead complex projects and cross-functional teams.
Nice to have
- Experience in a production radiopharmaceutical facility.
- Certification in a pharmaceutical Quality-related discipline, Lean Six Sigma, or project management training/certification.
Pay
$124,114 - $161,187 USD (base salary)
Tools
GMP, FDA Title 21 CFR 210/211, ICH Guidelines, ALCOA+, 21 CFR Part 11, Quality Management Systems
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