QA Lead - Radiopharmaceutical GMP & Compliance

TerraPower LLC.; Everett (WA); On-site; USD 117,000 - 152,000; Full time

Benefits offered by this job

Competitive compensation

Medical and wellness benefits

401k plan

PTO 21 days annually

Relocation assistance

Professional development

Job summary

TerraPower Isotopes seeks an experienced Quality Assurance Specialist to support Ac-225 production at the Everett, WA facility. The role emphasizes GMP compliance, regulatory alignment with FDA 21 CFR 210/211 and ICH guidelines, radiation safety, and policy development.

The successful candidate will manage batch records, CAPA, deviations, audits, and supplier qualification while coordinating with Operations, QC, Engineering, R&D, and Procurement to meet company objectives.

Qualifications

• Bachelor’s degree in life sciences, engineering, or related field (or equivalent qualification through experience).
• 6+ 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.

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 approval of quality documentation, including deviations, change controls and CAPA, and complaints.
• Support supplier qualification program, including verifying supplier compliance with applicable quality requirements, focusing on critical materials, services, and supplier 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 project driven by Quality.
• Support implementation of Quality Management Systems.
• Support development processes for validation/qualification of equipment, facility, and/or 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, such as radiation safety, in all quality activities.
• Provide comprehensive, Quality-related training to colleagues within TPI and act as a resource for quality related inquiries
• Perform other general duties associated with the position as required by supervision.

Skills

Cross-functional leadership

Excellent written and verbal comms

Quality principles

Project management

Documentation review

Audits and CAPA

Education

Bachelor’s degree in life sciences, engineering, or related field

Equivalent qualification through experience

Tools

Quality Management Systems (QMS)

FDA Title 21 CFR 210/211

ICH Guidelines

Job description

TerraPower Isotopes seeks an experienced Quality Assurance Specialist to support Ac-225 production at the Everett, WA facility. The role emphasizes GMP compliance, regulatory alignment with FDA 21 CFR 210/211 and ICH guidelines, radiation safety, and policy development.

The successful candidate will manage batch records, CAPA, deviations, audits, and supplier qualification while coordinating with Operations, QC, Engineering, R&D, and Procurement to meet company objectives.