CSV Analyst
Core
Prepare, execute, and maintain validation deliverables for Microsoft Excel spreadsheet solutions in regulated environments.
Role type
Systems Analyst II (CSV)
Builds
Validated spreadsheet solutions and computerized systems for regulated business processes
Domain
Life Sciences / Regulatory Compliance (GxP, FDA)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CSV lifecycle management, GxP and FDA regulatory knowledge, data integrity principles, SDLC in regulated environments, Microsoft Excel validation (formulas, macros, data controls), validation documentation authoring, test execution and defect management, change control management
Preferred skills
HP ALM/ALM, MasterControl, ServiceNow
Responsibilities
Assess GxP impact and risk to determine validation activities, author and execute validation plans and protocols, manage deviations and defects through resolution, maintain systems in a validated state
Seniority
Mid-level, hands-on IC