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Jobs · Administrative · Indiana

Data Reviewer, Quality Control Microbiology

Bristol Myers Squibb EU Policy · Greater Indianapolis · 3 wk ago
On-siteAdministrative$31.07–$37.64/hrPart-time

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients.

This position will collaborate with the Radiation Safety Officer (RSO) to ensure laboratory compliance with the radiation safety program at the Indianapolis site. The role requires working with and around ionizing radiation and hazardous chemicals. The position is located at RayzeBio’s manufacturing plant in Indianapolis, IN, and may require a flexible schedule, including occasional weekend or off-shift support based on business needs.

Responsibilities

  • Review and approve raw microbiological data including, but not limited to:
    • 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
  • Ability to work in moderate noise levels and exposure to manufacturing, laboratory, and logistics environments

Pay

Starting compensation range for a full-time employee (FTE) basis: $31.07 - $37.64 per hour. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Benefits

  • Health Coverage: Medical, pharmacy, dental, and vision care
  • Wellbeing Support: Programs such as 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 for 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 employees)
    • 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
    • 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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