Data Reviewer, Quality Control Microbiology

Bristol Myers Squibb • Indianapolis, IN

1d • Onsite

About The Position

RayzeBio is seeking a Quality Control Microbiology Data Reviewer for its Indianapolis manufacturing plant. Reporting to the Director- Microbiology Quality Control, the reviewer will collaborate with the Radiation Safety Officer to ensure laboratory compliance with the site radiation safety program. The role involves working with and around ionizing radiation and hazardous chemicals and is performed onsite, with a flexible schedule that may include occasional weekend or off-shift support based on business needs.

The Data Reviewer reviews microbiological testing data and records to support batch release, regulatory reporting, compliance, investigations, audits, and continuous improvement. The role works cross-functionally with Production, Quality Assurance, Validation, and Regulatory Affairs and supports data review processes in a cGMP-regulated radiopharmaceutical manufacturing environment.

Requirements

• Bachelor’s degree in Microbiology, Biology, or a related life science discipline.
• Minimum 3–5 years of experience in QC Microbiology or a related laboratory in a cGMP-regulated environment.
• Strong working knowledge of microbiological methods, environmental monitoring programs, and regulatory expectations.
• Strong knowledge of cGMP, USP <61>, <62>, <71>, and <85>, EU GMP Annex 1, and data integrity principles.
• Highly organized and detail-oriented, with the ability to manage multiple priorities and review tasks under tight deadlines.
• Effective communication skills and the ability to clearly document findings and work with cross-functional teams.
• Proactive approach to identifying process gaps and driving improvements.
• Excellent written and verbal communication skills.
• Ability to work in classified cleanroom environments while wearing appropriate gowning.
• Ability to work in office, warehouse, manufacturing, laboratory, and logistics environments, including areas requiring PPE.
• Ability to work with and around ionizing radiation and hazardous chemicals.
• Use AI tools to enhance individual productivity and quality of work.

Nice To Haves

• Experience supporting sterile manufacturing and/or radiopharmaceutical operations is highly desirable.

Responsibilities

• Review and approve raw microbiological data, including sterility, bioburden, endotoxin, media qualification and growth promotion, and environmental monitoring results.
• Verify that out-of-specification, out-of-trend, and atypical results are identified, documented, and investigated appropriately.
• Support microbiological investigations at the site.
• Ensure data is reviewed within defined timelines to support batch release and regulatory reporting.
• Ensure reviewed data meets cGMP, FDA, EMA, USP, and ICH requirements.
• Support internal and external audits and inspections, and serve as a subject matter expert for data review processes.
• Author, review, and approve SOPs, batch records, protocols, and technical reports related to microbiological testing.
• Compile and trend environmental monitoring and microbiological data for periodic review reports and management review.
• Identify data integrity issues and escalate them in accordance with site procedures.
• Partner with Production, Quality Assurance, Validation, and Regulatory Affairs to resolve data discrepancies and support investigations, including CAPAs and deviation reports.
• Support method validation and qualification activities by reviewing generated data packages.
• Identify non-value-add review steps and propose process improvements to streamline workflows and reduce cycle times.
• Collaborate with the Radiation Safety Officer to ensure laboratory compliance with the radiation safety program.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
• Flexible Time Off without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
• For non-exempt employees, RayzeBio employees, and employees in Puerto Rico: 160 hours of paid vacation annually for new hires, subject to manager approval.
• 11 paid company holidays annually.
• Three optional holidays for non-exempt employees, RayzeBio employees, and employees in Puerto Rico.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Potential eligibility for discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level