Quality Control Environment Monitoring Supervisor

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Rayze Bio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. Rayze Bio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, Rayze Bio aims to be the global leader in radiopharmaceuticals.

* Rayze Bio is seeking a Quality Control Environment Monitoring Supervisor, reporting to the Director
- Microbiology Quality Control. The position will provide oversight for the environmental monitoring program supporting the GMP manufacturing operations related to radiopharmaceuticals. This role will be responsible for the day-to-day EM activities including viable/non-viable monitoring. The supervisor will ensure data trending are executed in compliance with regulations, and company quality standards, troubleshooting efforts, ensuring compliance with regulatory and QA system requirements, and maintaining high standards of quality for radioisotopes and radiopharmaceutical product release.

The Environment Monitoring Supervisor will collaborate with the Radiation Safety Officer (RSO) to ensure laboratory compliance with the radiation safety program at the Indianapolis site. The position will require the applicant to work with and around ionizing radiation and hazardous chemicals.

* The position will be located at Rayze Bio's manufacturing plant, in Indianapolis, IN.

* Job Responsibilities

* Manage EM program

* Supervise EM technicians /analysts performing viable, non-viable, personnel, settling plates monitoring in ISO- classified and controlled spaces.

* Schedule routine and non-routine EM activities to support manufacturing operations and facility readiness.

* Oversee execution of environmental and utility sampling including microbial identification workflows.

* Ensure laboratory activities follow SOPs, aseptic techniques, gowning procedures and safety requirements.

* Review and/or approve EM data, escalate excursions.

* Lead or support investigations for EM
-related investigations, including root cause analysis and CAPA development to ensure timely close-out.

* Ensure EM program documentation such as SOPs, forms, maps are current and audit-ready.

* Ensure EM trending, monthly/quarterly reports are performed in a timely manner.

* Approval of SOPs, trend data, investigations, non-conformances, validation protocols, reports, validation/verifications and equipment qualifications.

* Develop and maintain appropriate documentation, particularly data analysis and team KPI's.

* Team Management

* Supervise a team of EM technicians /analysts.

* Assign tasks and prioritize workload to ensure timely completion of 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 site.

* Coach team members, conduct performance evaluations and support career development.

* Continuous Improvement

* Support continuous improvement programs for EM such as new EM technologies and improve data visibility.

* Identify other opportunities for process improvements and implement changes to increase quality and efficiency within the Quality…