Quality Assurance Specialist

TerraPower • Everett, WA

20d • Onsite

About The Position

TerraPower Isotopes (TPI), a division of TerraPower focused on medical isotope development and radiopharmaceutical applications, is seeking an experienced Quality Assurance Specialist to support Ac-225 production at its Everett, Washington manufacturing facility. The role supports quality assurance activities and helps ensure compliance with Good Manufacturing Practices (GMP), FDA Title 21 CFR 210/211, ICH guidance, radiation safety requirements, and company policies. Responsibilities span batch and material disposition, deviations, CAPA, change controls, procedures and policies, supplier qualification and monitoring, audits, and quality system implementation. The position requires sound judgment in balancing compliance with business needs.

The Quality Assurance Specialist reports to the Manager, Quality Assurance and works with multidisciplinary teams across Operations, Quality Control, Engineering, R&D, Procurement, Project Management, and Commercial Services. The role also supports ongoing production, validation and qualification processes, continuous improvement, data integrity, and quality training. Occasional evening or weekend work may be required. Travel is 0–10%.

TerraPower Isotopes is an Equal Opportunity Employer. Applicants may be subject to U.S. Government export-control review. The posted Washington State salary range is $116,852–$151,757; offers are typically in the lower to middle portion of the range and depend on qualifications and experience.

Requirements

• Bachelor’s degree in a life sciences discipline, engineering, or a related field, or equivalent qualification through experience.
• At least 6 years of industry experience in a regulated production environment, including at least 3 years of prior experience in a Quality Assurance role.
• Demonstrated experience working within Quality Systems.
• Strong working knowledge of quality principles and demonstrated success managing complex projects and a wide range of responsibilities.
• Experience in a quality program compliant with FDA/cGMP requirements, including Title 21 CFR 210/211 and ICH guidance.
• Strong attention to detail and ability to interpret federal regulations, guidance, and standards.
• Ability to incorporate applicable requirements into TPI documentation and advise personnel on compliance.
• Flexibility to adjust to changing priorities and schedules in a dynamic environment.
• Strong interpersonal skills and demonstrated ability to lead cross-functional teams and drive accountability.
• Excellent written and verbal communication skills, including technical writing and executive-level reporting.
• High degree of trust and integrity, open communication, respect, and commitment to teamwork.
• Ability to perform the position’s physical functions, with or without accommodation, including extended sitting, bending or stooping, gripping, fine motor work, and safely lifting up to 25 pounds.

Nice To Haves

• Certification in a pharmaceutical Quality-related discipline.
• Lean Six Sigma or project management training or certification.
• Experience in a production radiopharmaceutical facility.

Responsibilities

• Review batch records, Certificates of Analysis, and other 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, verify supplier compliance with applicable quality requirements, and monitor supplier performance, particularly for critical materials and services.
• Provide Quality support for ongoing production activities at the Everett Laboratory.
• Support internal and external audits by preparing documentation, analyzing findings, and implementing corrective actions.
• Support Quality-driven project workstreams and continuous improvement projects.
• Support implementation of Quality Management Systems.
• Support development processes for validation and qualification of equipment, facilities, and manufacturing processes.
• Ensure data integrity compliance across quality systems, including ALCOA+ principles and 21 CFR Part 11 requirements.
• Balance quality requirements with safety, including radiation safety, in quality activities.
• Provide Quality-related training to TPI colleagues and serve as a resource for quality inquiries.
• Perform other general duties as required by supervision.

Benefits

• Competitive compensation salary.
• Eligible participation in discretionary short-term incentive payments.
• Comprehensive medical and wellness benefits.
• Medical insurance.
• Vision insurance.
• Dental insurance.
• Life and disability benefits.
• Gender affirmation benefits.
• Parental leave.
• 401(k) plan.
• 21 days of annually accrued paid time off.
• 10 paid holidays.
• Relocation assistance.
• Professional and educational support opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior