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Quality Assurance Engineer, TerraPower Isotopes
2 months ago
TITLE: Quality Assurance Engineer, TerraPower Isotopes LOCATION: Everett, WA, USA The TerraPower Isotopes (TPI) division has been established to pursue medical isotopes development--advancing nuclear science for significant human health benefits. We seek to support revolutionary radiotherapies for treatments of various cancers through the supply of radioisotopes. TerraPower currently has unique access to a supply of thorium for the long-term production of actinium-225 in the growing alpha therapy market and intends to expand into other nuclear related medical treatments. The TerraPower Isotopes (TPI) program is an integral part of the Washington State based TerraPower team, a company working to raise living standards globally. In 2006, the company originated with Bill Gates and a group of like-minded visionaries who evaluated the fundamental challenges to raising living standards around the world. TerraPower's mission is to be a world leader in new nuclear technologies, while developing innovators and future leaders in the nuclear field. TerraPower is seeking to hire highly motivated and forward-thinking professionals who are interested in focusing on advanced radiopharmaceutical applications and influencing change within nuclear medicine. TerraPower is an Equal Opportunity Employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. In addition, as a federal contractor, TerraPower has instituted an Affirmative Action Plan (AAP) to proactively recruit, hire, and promote women, minorities, disabled persons and veterans. Quality Assurance Engineer, TerraPower Isotopes TPI is seeking a Quality Assurance Professional to join a group of highly motivated and forward-thinking professionals in developing a system to isolate unique radioisotopes intended for use in targeted cancer therapy. The successful candidate will be a key contributor in designing a quality assurance program for this initiative, including development of a Quality Management System and implementation of a LIMS system. The position requires excellent judgement and discretion in balancing compliance and business resolutions. Responsibilities * Contribute to development and implementation of the Quality Program for TPI. Author, revise, and manage the approval of site procedures and policies related to Quality. * Provide Quality-related training to colleagues involved in the TPI enterprise. * Initiate risk-management activities and involvement in risk-based decision making. Balance the requirements for safety, such as radiation safety, in all quality initiatives. * Support the Quality Assurance CAPA system; assist in developing corrective actions; monitor implementation. * Develop and implement a supplier qualification program. Monitor supplier performance. * Participate in Quality system audits (supplier, customer, and internal audits) as required. Contribute to resolution of audit findings and follow up. * Key contributor to Change Control involving product or process changes. * Develop processes for validation/qualification of equipment, cleaning, and/or manufacturing processes. Review and approve results. * Assemble, analyze, and report QA data metrics to detect trends and identify areas for improvement. * Perform other general duties associated with the position as required by supervision. Key Qualifications and Skills * Bachelor's level degree in Science or Engineering * 3+ years' experience in Quality or a regulated operational production environment (e.g., ISO 9001, cGMP or radiopharmaceutical industries). * Experience working within a quality program compliant to FDA/cGMP requirements Title 21 CFR
