Location: Indianapolis
Job Summary
RayzeBio, a Bristol Myers Squibb company, is seeking applicants for a Data Reviewer to support the review of laboratory data generated from microbiological testing and environmental monitoring. Reporting to the Assistant Manager of Microbiology, this role supports the production of targeted alpha therapy (TAT) radiopharmaceuticals at the RayzeBio Indianapolis manufacturing facility. We are seeking a detail-oriented individual who will work closely with lab personnel, quality assurance, and other cross-functional teams to ensure accuracy, completeness, and timely review of data to support the release of products and environmental monitoring trend reports.
Key Responsibilities:
- Review data from microbiological testing of finished products, in-process samples, raw materials, and environmental monitoring (air, surface, and personnel)
- Ensure all data complies with GMP regulations, radiation safety guidelines, and quality standards
- Verify that test results are within acceptable limits and properly documented, including deviations, out of specifications (OOS), and out-of-trend (OOT) events
- Identify and address discrepancies in test results and documentation by working closely with the laboratory and QA teams to ensure corrective actions are taken
- Perform trend analysis of environmental monitoring data and escalate issues to management as necessary
- Ensure data integrity and compliance with electronic data management systems
- Collaborate with internal and external auditors during data integrity audits and inspections
- Support and provide technical, quality, and/or safety information pertaining to environmental monitoring tests to lab management on routine basis
- Support investigations of environmental excursions to identify root causes and implement corrective actions as required
- Proactively identify opportunities for improvements to the data review and investigation processes
- Perform other duties as required by management
- Extended hours or weekend work based on radiopharmaceutical manufacturing schedule may be required
Education & Experience:
- BS in biology, microbiology, or other life science-related field with five to seven years of experience in pharmaceutical or other cGMP experience. Advanced degrees may be acceptable with less experience, however direct experience with cGMP technical writing is required.
- Thorough understanding of cGMP regulations, ICH guidelines, FDA and other regulatory process investigation process required.
- Experience with sterile manufacturing and/or radiopharmaceuticals preferred.
- Experience tracking maintenance of laboratory equipment preferred.
Skills & Qualifications:
- Excellent professional ethics, integrity, and ability to maintain confidential information.
- Highly motivated with the ability to work independently, without direction, or with others in a team environment
- Ability to multi-task and prioritize work based on multiple workflows
- Ability to handle hazardous materials safely
- Good organizational practices required
- Strong analytical and problem-solving skills
- Ability to work well and communicate effectively with multiple stakeholders
- Strong written and oral communication skills
- Work with computer programs, including but not limited to Microsoft Office
Please click here to apply.
