Validation Analyst 1
Core
Managing validation projects for small customer accounts to ensure compliance with government and customer requirements in the biopharma industry.
Role type
Junior Validation Analyst
Builds
Validated processes and programs for new customer/product/system launches
Domain
Biopharma / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation protocol generation, audit assistance, documentation management, change control reporting, deviation investigation, regulatory compliance knowledge (cGMP, GCP, GAMP, 21CFR), customer communication
Preferred skills
Attention to detail, independent work, adaptability, decision making
Technologies
Common computer programs
Responsibilities
Perform validation activities to assure compliance, prepare validation protocols and plans, ensure documentation completion and closure, prepare change control reports, investigate validation deviations, attend customer meetings, review production jackets
Seniority
Entry-level, supervised IC
