Senior Data Review Specialist
Core
Perform data review of routine and complex analytical data from chromatography, smoke, inorganics, and microbiology labs to ensure accuracy and compliance with GMP/GLP/ISO 17025 standards.
Role type
Senior Data Review Specialist (Laboratory Quality)
Builds
Analytical test results and compliance documentation for clients in food, environment, pharmaceutical, and cosmetic industries.
Domain
Life sciences, analytical chemistry, and regulatory compliance.
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Data review of chromatography methods (GCMS, LC, HVGC), assessment of analytical data for accuracy, proficiency in LIMS, understanding of instrumentation (GC-FID, LCMS, ICPMS, etc.), development and editing of SOPs, complex calculations in Excel, adherence to Good Documentation Practices.
Preferred skills
Experience in cGMP and/or ISO 17025 environments, knowledge of wet chemistry and microbiology lab procedures.
Technologies
GCMS, LCMS, LIMS, Microsoft Excel, Microsoft Office Suite.
Responsibilities
Review single, double, and multi-analyte chromatography data; assess analytical data for accuracy and compliance; develop and edit Work Instructions and SOPs; complete monthly reports on production and accomplishments; lead completion of capacity metrics and hot studies; collaborate with QA and analysts on documentation.
Seniority
Senior, hands-on IC