Senior QA Lead, Radiopharmaceuticals – GMP/cGMP

TerraPower LLC.; Everett (WA); On-site; USD 124,000 - 161,000; Full time

Benefits offered by this job

Competitive Compensation

Discretionary short-term incentive

Medical and Wellness Benefits

401k Plan

PTO 21 days

10 paid holidays

Relocation Assistance

Professional and Educational Support

Job summary

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

You will lead QA activities, review deviations, CAPAs, change controls, and audits to ensure data integrity. Collaborating with Operations, QC, Engineering, R&D and Procurement, you will balance compliance with production needs and

Qualifications

• Bachelor’s degree in life sciences discipline, engineering, or related field.
• 8+ years’ experience in a regulated production environment, including QA.
• Experience with GMP, FDA Title 21 CFR 210/211 and ICH guidance.

Responsibilities

• Lead quality-driven project teams to support organizational initiatives.
• Optimize site policies for cGMP implementation.
• Review batch records and Certificates of Analysis for disposition.
• Approve quality documentation including deviations and CAPA.
• Provide QA support for routine production at Everett Laboratory.
• Lead internal, supplier, and customer audits; resolve findings.

Skills

Bachelor’s degree

Quality Assurance

8+ years

FDA CFR 210/211

ICH Guidelines

Quality Systems

Audits

Documentation

Regulated production

Cross-functional

Education

Bachelor’s degree in life sciences or engineering

Job description

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

You will lead QA activities, review deviations, CAPAs, change controls, and audits to ensure data integrity. Collaborating with Operations, QC, Engineering, R&D and Procurement, you will balance compliance with production needs and