Senior Quality Assurance Specialist (Radiopharmaceuticals)

Location: Everett, Washington, United States; onsite at the manufacturing facility

Salary: $124,114–$161,187 per year

Company

hirify.global Isotopes develops medical isotopes and radiopharmaceutical applications, including actinium-225 production for cancer radiotherapies, as part of hirify.global’s nuclear technology program.

What you will do

• Lead and contribute to quality-driven projects supporting cGMP manufacturing and organizational initiatives.
• Review batch records, Certificates of Analysis, deviations, change controls, CAPA, complaints, and other quality documentation for product disposition.
• Support routine production activities and implement quality management systems at the Everett laboratory.
• Lead internal, supplier, and customer audits and drive timely resolution of findings.
• Support supplier qualification, equipment and process validation, and monitoring of critical suppliers and service providers.
• Deliver quality training, promote quality culture, and provide subject-matter guidance across Operations, Quality Control, Engineering, R&D, Procurement, Project Management, and Commercial Services.

Requirements

• Bachelor’s degree in life sciences, engineering, or a related field, or equivalent experience.
• 8+ years of industry experience in a regulated production environment, including 3+ years in Quality Assurance.
• Experience with quality systems and FDA/cGMP requirements, including 21 CFR 210/211 and ICH Guidance.
• Strong knowledge of quality principles, federal regulations, technical writing, project leadership, and executive-level reporting.
• Experience with data integrity, ALCOA+ principles, and 21 CFR Part 11 requirements.
• Foreign nationals may be subject to U.S. Government export-control review and authorization requirements.

Nice to have

• Experience in a production radiopharmaceutical facility.
• Certification in pharmaceutical Quality, Lean Six Sigma, or project management.

Culture & Benefits

• Full-time employment with comprehensive medical, dental, vision, life, disability, and wellness benefits.
• 401(k) plan, paid parental leave, 21 accrued PTO days annually, and 10 paid holidays.
• Relocation assistance and professional and educational support opportunities.
• Occasional evening or weekend work may be required; travel is expected at 5–10%.
• Physical requirements include extended sitting, prolonged repetitive work, stairs, keyboard use, and safely lifting up to 25 pounds.