TerraPower Isotopes is seeking an experienced Quality Assurance Specialist to support Ac-225 production at the Everett, WA manufacturing facility.
The successful candidate will have experience in a quality assurance role with focus on ensuring compliance with Good Manufacturing Practices (GMP), regulatory guidelines (FDA Title 21 CFR 210/211 and ICH Guidelines), radiation safety, and company policies. The Quality Assurance Specialist will support the quality assurance activities including batch and material disposition, deviations, CAPA, change controls, authoring procedures and policies, supplier qualification and performance monitoring, audits, and system implementation.
The position requires excellent judgement and discretion in balancing compliance and business resolutions. The Quality Specialist will report to the Manager, Quality Assurance and work closely with a multidisciplinary team including Operations, Quality Control, Engineering, R&D, Procurement, Project Management, and Commercial Services teams to achieve company objectives.