Quality Assurance Specialist – Radiopharmaceuticals GMP

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

Benefits offered by this job

Competitive compensation

Salary with discretionary incentive

Medical and wellness benefits

Parental leave

401k plan

Generous PTO (21 days)

Job summary

TerraPower Isotopes (TPI) seeks an experienced Quality Assurance Specialist to support Ac-225 production at the Everett, WA facility. The role focuses on GMP compliance, FDA Title 21 CFR 210/211, and ICH guidelines, with responsibilities spanning batch review, policy management, deviations, CAPA, supplier qualification, audits, and data integrity.

You will report to the Manager, Quality Assurance and collaborate with Operations, QC, Engineering, R&D, Procurement, and Commercial Services to

Qualifications

• Bachelor's degree in life sciences, engineering, or related field.
• 6+ years in regulated production; 3+ in QA.
• Experience with FDA cGMP Title 21 CFR 210/211 and ICH guidelines.
• Strong knowledge of quality systems and project management.
• Ability to balance compliance with production needs.

Responsibilities

• Review batch records, COAs, and documentation for accuracy.
• 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, ensuring compliance with quality requirements.
• Provide QA support for ongoing production activities at Everett Laboratory.
• Support audits by preparing documentation, analyzing findings, and implementing corrective actions.
• Assist with quality system implementations and continuous improvement projects.
• Ensure data integrity across quality systems per ALCOA+ and 21 CFR Part 11.
• Balance quality with radiation safety in all activities.
• Provide QA training to colleagues and support inquiries.

Skills

Quality Assurance

Regulatory compliance

Documentation review

CAPA & deviations

Audit support

Cross-functional collaboration

Data integrity

Education

Bachelor's degree in life sciences/engineering or related field

Tools

Lean Six Sigma

Project Management

Job description

TerraPower Isotopes (TPI) seeks an experienced Quality Assurance Specialist to support Ac-225 production at the Everett, WA facility. The role focuses on GMP compliance, FDA Title 21 CFR 210/211, and ICH guidelines, with responsibilities spanning batch review, policy management, deviations, CAPA, supplier qualification, audits, and data integrity.

You will report to the Manager, Quality Assurance and collaborate with Operations, QC, Engineering, R&D, Procurement, and Commercial Services to