Professional Services - QA Specialist

Order Type : Direct Hire

Job description Job Overview Quality Control, reporting to the Quality Supervisor. The position will oversee quality control testing activities related to radiopharmaceuticals. This role will involve managing a team of QC chemists, ensuring compliance with regulatory and QA system requirements, and maintaining high standards of quality for radiopharmaceutical product release. The Quality Control Supervisor will also ensure laboratory personnel comply with Environmental Health and Radiation safety standards within daily laboratory operations. Job Responsibilities Team Management Supervise and mentor a team of QC Chemists. Assign tasks and prioritize workload to ensure timely completion of Quality Control activities, including release of drug product and isotopes in an “on-time” and “right first time” manner. Foster a positive and collaborative work environment within the lab and with external stakeholders both within the site and outside the side. Work with Management and Planning to schedule workflow and projects across the Quality Control team. Continuous Improvement Participate in method transfer activities from CMO or internal research facility to the production and QC teams, ensuring accuracy and reliability of data. Identify other opportunities for process improvements and implement changes to increase quality and efficiency within the Quality Control laboratories. Provide continuous improvement suggestions for analysis as novel radiopharmaceuticals move through regulatory stages to commercialization. Release of product and other studies Perform analyses of validated/verified methods to support novel RayzeBio Radiopharmaceuticals, raw materials, and components when required. Collaborate with Manager and/or Reviewer to ensure all documentation for release is reviewed. Work with Manager and/or Investigation Write to ensure any discrepancies are resolved in a timely manner. Quality Assurance/Regulatory Compliance Assist in the routine calibration and maintenance of laboratory equipment. Ensure schedule compliance to ensure GMP readiness. Work with Quality Assurance and Management to implement internal audits. Participate in troubleshooting of issues and implement corrective actions to improve quality processes as a result of investigations or internal audits. Develop and maintain appropriate documentation, particularly data analysis and team KPI’s. Work with RSO and QA to ensure compliance with GMP regulations, safety guidelines, and quality standards (FDA, USP, NRC, EP, and other regulatory agencies as needed). Assist in the reviewing of Standard Operating Procedures and other documents Weekend work, early starts, or late ending times may be required. Up to 10% of travel may be required.