Data Reviewer, Quality Control Microbiology

Role: Quality Control Microbiology Data Reviewer at RayzeBio, focused on reviewing microbiological data to ensure compliance with cGMP, FDA, EMA, USP, and ICH standards within a radiopharmaceutical manufacturing environment. Responsibilities include reviewing sterility, bioburden, endotoxin, and environmental monitoring data; supporting investigations and audits; authoring SOPs and technical reports; and collaborating with multiple departments to resolve data discrepancies. Requirements: Bachelor's in Microbiology, Biology, or related field; 3-5 years in QC Microbiology within regulated labs; experience with sterile manufacturing or radiopharmaceuticals is highly desirable; strong knowledge of microbiological methods, data integrity, and regulatory expectations. Skills include meticulous organization, communication, ability to manage multiple tasks under deadlines, and working in classified clean environments. The role involves on-site work at Indianapolis, with flexibility for occasional weekend or off-shift support. High-value: microbiological testing, radiopharmaceutical manufacturing, cGMP compliance, regulatory audits, data review, and investigation support at a manufacturing plant.