Data Reviewer, Quality Control Microbiology
Bristol Myers Squibb
August 06, 2026
On-site
Indianapolis, IN
Operations
Summary
RayzeBio is seeking a Quality Control Microbiology Data Reviewer (reporting to the Director—Microbiology Quality Control). Collaborate with the Radiation Safety Officer (RSO) to ensure laboratory compliance with the radiation safety program at the Indianapolis site. Work with and around ionizing radiation and hazardous chemicals.
Job Responsibilities
- Review and approve raw microbiological data including: sterility testing; bioburden testing; endotoxin testing; media qualification/growth promotion; Environmental Monitoring (viable air, surface, personnel).
- Verify OOS/OOT/atypical results are properly identified, documented, and investigated.
- 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/external audits and inspections; act as a subject matter expert for data review processes.
- Author/review/approve SOPs, batch records, protocols, and technical reports related to microbiological testing.
- Compile and trend EM and microbiological data for periodic and management review reports.
- Identify data integrity issues and escalate appropriately.
- Partner with Production, QA, Validation, and Regulatory Affairs to resolve data discrepancies and support investigations (CAPAs, deviation reports).
- Support method validation/qualification by reviewing data packages.
- Identify non-value-add review steps; propose process improvements to streamline workflows and reduce cycle times.
Education/Experience
- Bachelor’s degree (BS) in Microbiology, Biology, or related life science (required).
- 1–2 years QC Microbiology or related laboratory experience in a cGMP-regulated environment (required).
- Experience with sterile manufacturing and/or radiopharmaceutical operations (highly desirable).
Skills/Qualifications
- Highly organized, detail-oriented; manage multiple priorities in a fast-paced environment.
- Strong knowledge of microbiological methods, EM programs, cGMP/USP/EU GMP Annex 1, and data integrity principles.
- Ability to manage multiple review tasks under tight deadlines.
- Effective communication; clearly document findings and interface with cross-functional teams.
- Proactive in identifying process gaps and driving improvements.
- Ability to work in classified cleanroom environments with appropriate gowning.
- Uses AI tools to enhance productivity and quality of work.
Location/Hours
- Indianapolis, IN manufacturing plant; flexible schedule with occasional weekends or off-shift support based on business needs.
Compensation/Benefits (as stated)
- $31.07–$37.64 per hour (start range). Additional incentives may be available based on eligibility.
- Health coverage; wellbeing programs; 401(k), disability, life insurance, and other listed protections. Paid time off (details by employee type/location).
Physical/Work Environment
- Interaction across office, warehouse, and manufacturing environments; PPE required in certain areas.
- Moderate noise levels; exposure to manufacturing/lab/logistics environments.
RayzeBio is seeking a Quality Control Microbiology Data Reviewer (reporting to the Director—Microbiology Quality Control). Collaborate with the Radiation Safety Officer (RSO) to ensure laboratory compliance with the radiation safety program at the Indianapolis site. Work with and around ionizing radiation and hazardous chemicals.
Job Responsibilities
- Review and approve raw microbiological data including: sterility testing; bioburden testing; endotoxin testing; media qualification/growth promotion; Environmental Monitoring (viable air, surface, personnel).
- Verify OOS/OOT/atypical results are properly identified, documented, and investigated.
- 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/external audits and inspections; act as a subject matter expert for data review processes.
- Author/review/approve SOPs, batch records, protocols, and technical reports related to microbiological testing.
- Compile and trend EM and microbiological data for periodic and management review reports.
- Identify data integrity issues and escalate appropriately.
- Partner with Production, QA, Validation, and Regulatory Affairs to resolve data discrepancies and support investigations (CAPAs, deviation reports).
- Support method validation/qualification by reviewing data packages.
- Identify non-value-add review steps; propose process improvements to streamline workflows and reduce cycle times.
Education/Experience
- Bachelor’s degree (BS) in Microbiology, Biology, or related life science (required).
- 1–2 years QC Microbiology or related laboratory experience in a cGMP-regulated environment (required).
- Experience with sterile manufacturing and/or radiopharmaceutical operations (highly desirable).
Skills/Qualifications
- Highly organized, detail-oriented; manage multiple priorities in a fast-paced environment.
- Strong knowledge of microbiological methods, EM programs, cGMP/USP/EU GMP Annex 1, and data integrity principles.
- Ability to manage multiple review tasks under tight deadlines.
- Effective communication; clearly document findings and interface with cross-functional teams.
- Proactive in identifying process gaps and driving improvements.
- Ability to work in classified cleanroom environments with appropriate gowning.
- Uses AI tools to enhance productivity and quality of work.
Location/Hours
- Indianapolis, IN manufacturing plant; flexible schedule with occasional weekends or off-shift support based on business needs.
Compensation/Benefits (as stated)
- $31.07–$37.64 per hour (start range). Additional incentives may be available based on eligibility.
- Health coverage; wellbeing programs; 401(k), disability, life insurance, and other listed protections. Paid time off (details by employee type/location).
Physical/Work Environment
- Interaction across office, warehouse, and manufacturing environments; PPE required in certain areas.
- Moderate noise levels; exposure to manufacturing/lab/logistics environments.