Credentials that matter
Skills and tools
- NRC Regulations
- cGMP
- Radiopharmaceutical
- 21 CFR 210/211
- Alcoa+
- 21 CFR Part 11
Required qualifications
- Bachelor's degree in life sciences, engineering, or related field (or equivalent experience)
- 6+ years' industry experience in a regulated production environment (ISO 9001, cGMP pharmaceutical or radiopharmaceutical)
- 3+ years of prior experience in a Quality Systems role
- Strong working knowledge of quality principles with proven success managing complex projects
- Experience working within a quality program compliant to FDA/cGMP requirements Title 21 CFR 210/211 and ICH Guidance
- Strong attention to detail with ability to interpret federal regulations and standards
- Ability to adjust to changing priorities and schedules in a dynamic environment
- Strong interpersonal skills with ability to lead cross-functional teams
- Excellent written and verbal communication skills, including technical writing proficiency and executive-level reporting
About this role
TerraPower Isotopes seeks an experienced Quality Systems Specialist to establish and maintain robust quality systems for Ac-225 radioisotope production at the Everett, WA facility. You'll ensure compliance with GMP, FDA Title 21 CFR 210/211, ICH Guidance, and NRC regulations while supporting the development of advanced radiopharmaceuticals for cancer treatment.
Responsibilities
- Author, revise, and manage approval of site policies and procedures related to Quality Systems
- Develop and implement data integrity policies to ensure accuracy, reliability, and compliance of organizational data
- Support supplier qualification program, verifying compliance with quality requirements for critical materials and services
- Participate in quality system audits (supplier, customer, and internal) and collaborate to resolve findings and track closure
- Support project workstreams and continuous improvement initiatives driven by Quality
- Support implementation of Quality Management Systems (QMS), Electronic Document Management System (EDMS), and Learning Management System (LMS)
- Support development and validation/qualification of equipment, facility, and manufacturing processes
- Ensure data integrity compliance across quality systems, including ALCOA+ principles and 21 CFR Part 11 requirements
- Balance quality requirements with safety considerations, including radiation safety in all quality activities
- Provide quality-related training to colleagues and serve as a resource for quality inquiries
Preferred qualifications
- Certification in a pharmaceutical Quality-related discipline, Lean Six Sigma, or project management
- Experience in a production radiopharmaceutical facility
Location, schedule, and travel
Everett, WA; onsite manufacturing facility
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