Data Reviewer, Quality Control Microbiology

$82.24k - $99.65k

Bristol Myers Squibb

RayzeBio seeks a Quality Control Microbiology Data Reviewer to review and approve microbiological testing data, support investigations, and ensure regulatory compliance at the Indianapolis manufacturing facility. The role involves working with ionizing radiation and hazardous chemicals in a cGMP-regulated environment.

Responsibilities

Review and approve raw microbiological data including sterility, bioburden, and endotoxin testing
Identify and investigate out-of-specification and atypical results with proper documentation
Ensure reviewed data meets cGMP, FDA, EMA, USP, and ICH regulatory requirements
Support microbiological investigations and partner with cross-functional teams on data discrepancies
Compile and trend environmental monitoring data for periodic management review

Requirements

Bachelor's degree in Microbiology, Biology, or related life science
3-5 years QC Microbiology experience in cGMP-regulated environment
Strong knowledge of microbiological methods and regulatory expectations
Proficiency with cGMP, USP standards, and data integrity principles
Experience with sterile manufacturing or radiopharmaceutical operations preferred
Ability to work in cleanroom environments with appropriate gowning
Detail-oriented with strong written and verbal communication skills

Compensation: $82,236 - $99,650 base

Apply

Vacancy posted 8 days ago

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