Senior CSA Analyst - PA Licensed

Job Summary

Supporting ongoing plasma systems and applications in a remote capacity, the full-time Senior CSA Analyst - PA Licensed will manage validation activities, ensuring compliance with CSA principles and regulatory requirements while collaborating with IT, Quality, and project teams.

Key responsibilities

• Lead and execute CSA activities for computerized systems supporting Plasma operations
• Assess system and change risk, defining appropriate CSA strategies and testing approaches
• Develop and review CSA deliverables, including validation plans, test strategies, and change control documentation

Required qualifications

• Senior-level CSV/CSA experience within life sciences, biotechnology, or a regulated environment
• Strong understanding of GxP computerized systems and risk-based validation principles
• Experience supporting regulated application changes and system integrations
• Ability to independently define and execute validation strategies
• Experience working cross-functionally with IT, Quality, and technical teams