Quality Assurance Specialist

TerraPower·Everett, WA·Posted today

Nuclear industryUS only

About this role

TerraPower Isotopes seeks an experienced Quality Assurance Specialist to support actinium-225 production at the Everett, WA manufacturing facility. You'll ensure compliance with GMP, FDA regulations, and radiation safety while managing quality documentation, audits, supplier qualification, and continuous improvement initiatives in a dynamic radiopharmaceutical environment.

Responsibilities

—Review batch records, Certificates of Analysis, and documentation for accuracy and completion
—Author, revise, and manage approval of site policies and procedures
—Review and approve quality documentation, including deviations, change controls, CAPA, and complaints
—Support supplier qualification program, including verifying supplier compliance with applicable quality requirements and monitoring performance
—Provide Quality support for ongoing production activities at Everett Laboratory
—Support internal and external audits by preparing documentation, analyzing findings, and implementing corrective actions
—Support project workstreams and continuous improvement initiatives driven by Quality
—Support implementation of Quality Management Systems
—Support development processes for validation/qualification of equipment, facility, and manufacturing processes
—Ensure data integrity compliance across quality systems, including adherence to ALCOA+ principles and 21 CFR Part 11 requirements
—Balance quality requirements with safety considerations, including radiation safety, in all quality activities
—Provide Quality-related training to colleagues and serve as a resource for quality inquiries

Qualifications

—Bachelor's degree in life sciences, engineering, or related field (or equivalent qualification through experience)
—6+ years of industry experience in a regulated production environment (ISO 9001, cGMP pharmaceutical or radiopharmaceutical industries)
—3+ years of prior experience in a Quality Assurance role
—Demonstrated experience working within Quality Systems
—Strong working knowledge of quality principles with proven success managing complex projects
—Experience working within a quality program compliant to FDA/cGMP requirements Title 21 CFR 210/211 and ICH Guidance
—Strong attention to detail with ability to interpret federal regulations, guidance, and standards
—Ability to incorporate relevant requirements into documentation and provide compliance guidance
—Flexibility in adjusting to changing priorities and schedules in a dynamic environment
—Strong interpersonal skills with demonstrated ability to lead cross-functional teams and drive accountability
—Excellent written and verbal communication skills, including technical writing and executive-level reporting