Overview: The Oak Ridge National Laboratory seeks to hire a Quality Assurance and Regulatory Affairs - Senior Technical Staff Member. The position is in the National Isotope Development Center (NIDC), reporting to the NIDC manager. The NIDC serves as an interface with the isotope user community and coordinates isotope production across numerous program facilities (including ORNL) for the U.S. Department of Energy Isotope Program (DOE IP). The management function is responsible for the development, implementation, and maintenance of an integrated quality assurance system for the DOE IP.
The position works directly with the DOE IP site headquarter managers to develop, implement, and maintain quality systems that meet regulatory, operational, and customer specifications for all stable and radioisotope products produced at the multiple sites. The approved QA systems shall encompass the product life cycle beginning with specifications in the NIDC catalog and ending with a certified product at the time of delivery to the customer. The QA Specialist shall be responsible for providing guidance on compliance with the applicable quality assurance regulations at the DOE IP sites and shall participate in audits conducted by regulatory authorities and customers.
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