Data Reviewer
Core
Review laboratory data packages for accuracy, completeness, and compliance with approved procedures for medical devices microbiology studies.
Role type
Data Reviewer (Microbiology/QC)
Builds
Sterility by membrane filtration study data packages
Domain
Life Sciences / Medical Devices / Microbiology
Required skills
Data verification, Calculation verification, Transcription verification, Regulatory compliance knowledge (GMP/GxP), Documentation review, Discrepancy identification, Investigation review, Acceptance criteria validation
Preferred skills
M.Sc in Microbiology, Experience in CROs or GMP laboratories, Familiarity with sterility testing
Technologies
None stated
Responsibilities
Review laboratory data packages for accuracy and compliance, Verify calculations and data entries, Review test documentation for completeness, Identify and escalate discrepancies, Confirm investigations and corrections are documented, Ensure test results are supported by raw data, Maintain timely data release, Collaborate with lab personnel to resolve findings
Seniority
Junior to Mid-level (1-2 years experience)