Validation Analyst 3-1
Core
Manage validation projects for large customer accounts, ensuring compliance with government and customer requirements for biopharma processes and systems.
Role type
Validation Analyst (Quality Assurance)
Builds
Validated processes and programs for biopharma customers
Domain
Biopharmaceuticals / Quality Assurance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation protocol development, change control management, audit preparation, deviation investigation, regulatory compliance knowledge, documentation management, customer communication
Preferred skills
Problem identification and resolution, time management, decision making, goal setting
Technologies
Computer programs for complex tasks, validation software
Responsibilities
Prepare validation protocols, statements, and master plans; coordinate internal and customer approvals; investigate validation deviations and document corrective actions; prepare change control and validation history reports for audits; review production jackets and ensure document standards compliance
Seniority
Mid-level, individual contributor