Data Reviewer, Quality Control Microbiology
Core
Review and approve raw microbiological data (sterility, bioburden, endotoxin, environmental monitoring) to ensure compliance with cGMP and support batch release.
Role type
Quality Control Microbiology Data Reviewer
Builds
Microbiological testing data packages for sterile manufacturing and radiopharmaceutical operations
Domain
Biopharmaceuticals / Radiopharmaceuticals / Microbiology
Required skills
Microbiology methods, Environmental Monitoring (EM), cGMP, USP <61>/<62>/<71>/<85>, EU GMP Annex 1, Data integrity, Sterility testing, Bioburden testing, Endotoxin testing, Media qualification, Growth promotion testing
Preferred skills
Radiopharmaceutical operations experience, Sterile manufacturing experience, Process improvement, AI tools usage
Technologies
AI tools
Responsibilities
Review and approve raw microbiological data; Verify OOS/OOT/atypical results; Support microbiological investigations; Ensure data meets regulatory requirements; Author and review SOPs and batch records; Compile and trend EM data; Identify data integrity issues; Partner with cross-functional teams to resolve discrepancies; Support method validation; Propose process improvements
Seniority
Mid-level, hands-on IC