Quality Control Microbiology Laboratory Supervisor Indianapolis, IN

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Job Description:

RayzeBio is seeking a Quality Control Microbiology Laboratory Supervisor reporting to the Director- Microbiology Quality Control. The position will provide oversight for the daily microbiology activities supporting the GMP manufacturing operations related to radiopharmaceuticals. 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 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 RayzeBios manufacturing plant in Indianapolis IN.

Job Responsibilities:

Supervise daily QC Microbiology activities including but not limited to:

Sterility testing

Bioburden testing

Endotoxin testing

Media qualification and growth promotion testing

Environmental Monitoring (viable air surface and personnel)

Perform microbiology laboratory assays when needed.

Maintain strict adherence to aseptic technique gowning practices and cleanroom behaviors during laboratory activities.

Ensure all laboratory testing is performed in accordance with approved SOPs validated methods and regulatory requirements.

Review approve and/or verify microbiological data logbooks and electronic records to ensure accuracy completeness and ALCOA data integrity principles.

Ensure laboratory equipment materials and reagents are within calibration qualification and expiry prior to use.

Maintain inspectionready documentation and support internal audits regulatory inspections and thirdparty assessments.

Supervise coach and mentor QC Microbiology analysts and/or technicians.

Assign and prioritize workload to ensure testing is completed ontime and rightfirsttime.

Conduct performance feedback support skill development and assist with onboarding and qualification of new hires.

Ensure personnel are properly trained and qualified on methods SOPs aseptic techniques gowning and safety requirements including participation in TraintheTrainer activities where applicable.

Partner with Manufacturing QA Facilities Engineering MS&T and Radiation Safety to support production facility readiness and product release.

Identify opportunities for process improvement automation and efficiency within the QC Microbiology laboratory.

Support method lifecycle activities equipment qualification and technology improvements as needed.