Environmental Monitoring Data Reviewer/Investigator

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RayzeBio, 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. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Summary

The Environmental Monitoring (EM) Data Reviewer/Investigator plays a critical role in maintaining integrity and compliance of environmental monitoring data within a radiopharmaceutical manufacturing setting. The EM Data Reviewer/Investigator is responsible for performing comprehensive data review, analysis, and investigation of environmental monitoring results. This primarily remote position involves ensuring data accuracy, compliance, and integrity across air, surface, and personnel monitoring, and supporting the continual improvement of quality systems through collaboration and investigation.

Job Responsibilities

Essential duties and responsibilities include the following:

• Review and approve data from environmental monitoring (air, surface, and personnel) maintained on a cloud-based platform

• Ensure all data complies with GMP regulations and internal quality/procedural standards

• Verify that test results are within acceptable limits and properly documented, including alert and action level excursions

• Identify and address discrepancies in test results and documentation by working collaboratively with the laboratory and QA teams to drive timely corrective actions

• Perform trend analysis of environmental monitoring data and escalate issues to management as necessary

• Ensure data integrity and compliance with electronic data management systems, including regular reviews of audit trails

• Provide technical, quality, and/or safety information pertaining to environmental monitoring tests to lab management on a routine basis

• Support investigations of environmental excursions, participate in root cause identification, and help implement appropriate corrective actions

• Proactively identify opportunities for improvement in the data review and investigation processes

Education and Experience:

• BS in biology, microbiology, or other life science-related field

• 2+ years of experience in a GMP-regulated environment, preferably in pharmaceutical or radiopharmaceutical manufacturing

• Direct experience with environmental monitoring, quality systems, and laboratory data review highly preferred

• Experience supporting or leading laboratory or quality investigations is an asset

Skills and Qualifications

• Strong understanding of GMP, GLP, and data integrity requirements as they pertain to laboratory and environmental monitoring data

• Proficient with electronic/cloud-based data management platforms

• Demonstrated experience in data trending and analysis

• Meticulous attention to detail, excellent organizational and documentation dkills

• Strong analytical, problem-solving, and critical thinking abilities

• Effective communicator with the ability to collaborate across laboratory, QA, and management teams

• Self-motivated, able to work independently in a mostly remote environment while managing multiple priorities and meeting deadlines

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