QC Microbiology Data Reviewer – On‑Site, cGMP Expert

Bristol-Myers Squibb Company; Guam; Sur place; USD 82 000 - 100 000; Plein temps

Avantages offerts par ce poste

Flexible Time Off

11 Paid Holidays

Disability Insurance

Résumé du poste

RayzeBio is seeking a Quality Control Microbiology Data Reviewer at its Indianapolis site. The role reports to the Director of Microbiology Quality Control and works closely with the Radiation Safety Officer to ensure compliance with radiation safety programs.

The position is on-site and involves working with ionizing radiation and hazardous chemicals, supporting data integrity, regulatory compliance, and investigations across cGMP environments.

Qualifications

• Bachelor’s degree in Microbiology or related life science discipline required.
• 3–5 years of experience in a QC Microbiology or related 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.

Responsabilités

• Review and approve raw microbiological data including sterility, bioburden, endotoxin, media qualification, and environmental monitoring.
• Verify that OOS/OOT/atypical results are identified, documented, and investigated.
• Support microbiological investigations at the site.
• Ensure data is reviewed within defined timelines to support batch release and regulatory reporting.
• Audit support and serve as SME for data review processes; prepare SOPs, batch records, and technical reports.

Connaissances

Highly organized

Detail-oriented

Multi-tasking

Effective communication

Process improvement

Written communication

Verbal communication

Cleanroom gowning

AI tool usage

Formation

Bachelor's degree in Microbiology

Description du poste

RayzeBio is seeking a Quality Control Microbiology Data Reviewer at its Indianapolis site. The role reports to the Director of Microbiology Quality Control and works closely with the Radiation Safety Officer to ensure compliance with radiation safety programs.

The position is on-site and involves working with ionizing radiation and hazardous chemicals, supporting data integrity, regulatory compliance, and investigations across cGMP environments.