Data Reviewer, Quality Control Microbiology
Core
Review and approve raw microbiological data (sterility, bioburden, endotoxin, media qualification, environmental monitoring) to support batch release and regulatory compliance in a cGMP environment.
Role type
Quality Control Microbiology Data Reviewer
Builds
Microbiological test results and data integrity reports for radiopharmaceutical manufacturing
Domain
Biopharmaceuticals / Radiopharmaceuticals / Microbiology
Required skills
Microbiology methods, Environmental Monitoring (EM), cGMP compliance, Data integrity principles, Sterility testing, Bioburden testing, Endotoxin testing, Media qualification, OOS/OOT investigation, SOP authoring, Regulatory reporting (FDA/EMA/USP/ICH)
Preferred skills
Sterile manufacturing experience, Radiopharmaceutical operations experience, Cleanroom gowning proficiency, AI tool usage
Technologies
LIMS (implied by data review context), AI tools
Responsibilities
Review and approve raw microbiological data including sterility, bioburden, endotoxin, and environmental monitoring; Verify OOS/OOT results and support investigations; Author and review SOPs and batch records; Compile and trend data for management review; Identify data integrity issues; Partner with cross-functional teams to resolve discrepancies; Support method validation and qualification activities.
Seniority
Mid-level IC (3-5 years experience)