QC Microbiology Data Reviewer — Data Integrity & Compliance

Bristol Myers Squibb; Indianapolis (IN); On-site; USD 43,000 - 52,000; Full time

Benefits offered by this job

Health coverage

Job summary

RayzeBio in Indianapolis, IN is seeking a Quality Control Microbiology Data Reviewer to ensure laboratory compliance with radiation safety and cGMP requirements. You will collaborate with the Radiation Safety Officer and cross‑functional teams to review microbiological data and support regulatory reporting.

The role is based at RayzeBio’s Indianapolis manufacturing plant, with a flexible schedule including occasional weekends or off‑shift hours to meet business needs.

Qualifications

• Bachelor's degree in Microbiology or life sciences.
• 1-2 years in QC Microbiology in a cGMP environment.
• Experience with sterile manufacturing or radiopharmaceuticals is desirable.
• Strong knowledge of microbiological methods and regulatory expectations.

Responsibilities

• Review and approve raw microbiological data including sterility, bioburden, endotoxin and media testing.
• Ensure data meets cGMP, FDA, EMA, USP, and ICH requirements.
• Support audits and inspections; act as SME for data review processes.
• Author and review SOPs, batch records, protocols, and technical reports.
• Trend and compile EM and microbiological data for periodic reviews.

Skills

cGMP knowledge

Data integrity

AI tools usage

Communication skills

Education

BS in Microbiology

Tools

EM programs

Job description

RayzeBio in Indianapolis, IN is seeking a Quality Control Microbiology Data Reviewer to ensure laboratory compliance with radiation safety and cGMP requirements. You will collaborate with the Radiation Safety Officer and cross‑functional teams to review microbiological data and support regulatory reporting.

The role is based at RayzeBio’s Indianapolis manufacturing plant, with a flexible schedule including occasional weekends or off‑shift hours to meet business needs.