Quality Assurance Specialist

TerraPower LLC. • Everett, WA

3d • $116,852 - $151,757 • Onsite

About The Position

TerraPower Isotopes (TPI) is seeking an experienced Quality Assurance Specialist to support Actinium-225 (Ac-225) production at its Everett, Washington manufacturing facility. The role ensures compliance with Good Manufacturing Practices (GMP), FDA Title 21 CFR 210/211, ICH guidelines, radiation safety requirements, and company policies. It supports quality activities including 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 requirements with business needs.

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

Requirements

• Bachelor’s degree in life sciences, engineering, or a related field, or equivalent qualification through experience.
• At least 6 years of industry experience in a regulated production environment, such as ISO 9001 or cGMP pharmaceutical or radiopharmaceutical industries, 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 working within 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, incorporate requirements into company documentation, and provide compliance guidance to personnel.
• Flexibility to adjust to changing priorities and schedules in a dynamic environment; occasional evening or weekend work may be required.
• 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 abilities.
• High degree of trust and integrity, open communication, respect, and a commitment to teamwork.
• Ability to safely lift up to 25 pounds.
• Ability to perform work involving prolonged sitting, bending or stooping, grasping or gripping, fine motor control, visual and audio-focused work, stairs, typing or keyboard use, and a standard or seated working environment for more than 8 hours per day.

Nice To Haves

• Certification in a pharmaceutical Quality-related discipline.
• Lean Six Sigma training or certification.
• 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 the supplier qualification program by verifying supplier compliance with applicable quality requirements, particularly for critical materials and services, and monitoring supplier performance.
• 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 of validation and qualification processes for equipment, facilities, 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 requirements, 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 and eligibility to participate in discretionary short-term incentive payments.
• Comprehensive medical and wellness benefits, including medical, vision, dental, life, and disability coverage.
• 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