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Jobs · Administrative · Indiana

Data Reviewer, Quality Control Microbiology

Bristol Myers Squibb · Indianapolis, IN · 3 wk ago
On-siteAdministrative$31.07–$37.64/hrFull-time

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, combines the agility of an emerging biotech with the global resources of a leading oncology innovator. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for cancer patients. This role is based at our manufacturing plant in Indianapolis, IN, and involves working with ionizing radiation and hazardous chemicals.

About the role

The Quality Control Microbiology Data Reviewer will collaborate with the Radiation Safety Officer (RSO) to ensure laboratory compliance with the radiation safety program. The position requires a flexible schedule, including occasional weekend or off-shift support based on business needs.

Responsibilities

  • Review and approve raw microbiological data including:
    • Sterility testing
    • Bioburden testing
    • Endotoxin testing
    • Media qualification and growth promotion testing
    • Environmental Monitoring (viable air, surface, and personnel)
  • Verify that out-of-specification (OOS), out-of-trend (OOT), and atypical results are properly identified, documented, and investigated.
  • Ensure data is reviewed within defined timelines to support batch release and regulatory reporting.
  • Ensure all reviewed data meets cGMP, FDA, EMA, USP, and ICH requirements.
  • Support internal and external audits and inspections; 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 EM and microbiological data for periodic review reports and management review.
  • Identify data integrity issues and escalate appropriately in accordance with site procedures.
  • Partner with Production, Quality Assurance, Validation, and Regulatory Affairs teams to resolve data discrepancies and support investigations (e.g., CAPAs, 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.

Requirements

  • Bachelor’s degree (BS) in Microbiology, Biology, or a related life science discipline.
  • Minimum 1-2 years of experience in a QC Microbiology or related laboratory within a cGMP-regulated environment.
  • Experience supporting sterile manufacturing and/or radiopharmaceutical operations is highly desirable.
  • Strong working knowledge of microbiological methods, EM programs, and regulatory expectations.

Skills

  • Highly organized, detail-oriented, and capable of managing multiple priorities in a fast-paced environment.
  • Strong knowledge of cGMP, USP, EU GMP Annex 1, and data integrity principles.
  • Ability to manage multiple review tasks under tight deadlines.
  • Effective communication skills — able to clearly document findings and interface with cross-functional teams.
  • Proactive in identifying process gaps and challenging the status quo to drive improvements.
  • Excellent written and verbal communication skills.
  • Ability to work in classified cleanroom environments while wearing appropriate gowning.
  • Uses AI tools to enhance individual productivity and quality of work.

Physical Demands

  • Regular interaction within office, warehouse, and manufacturing environments, with PPE required in certain areas.

Work Environment

  • Moderate noise levels.
  • Exposure to manufacturing, laboratory, and logistics environments.

Pay

Starting compensation range: $31.07 - $37.64 per hour for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. Final, individual compensation will be decided based on demonstrated experience.

Benefits

  • Health Coverage: Medical, pharmacy, dental, and vision care.
  • Wellbeing Support Programs: BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
  • Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
  • Work-life Benefits:
    • Paid Time Off:
      • US Exempt Employees: Flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or RayzeBio).
      • Phoenix, AZ, Puerto Rico, and RayzeBio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
    • Based on eligibility, additional time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Year's Day.

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