Sr. CSV/QA Analyst
I.T. Solutions, Inc. · Posted Nov 5, 2026
- San Francisco, California, United States
- Hybrid
- Contract · Senior
- 5+ years
Lead CSV/QA Analyst overseeing validation and quality assurance for GxP IT systems and AI tools.
Responsibilities
- Serve as the QA point of contact and subject matter expert for CSV/CSA across GxP computerized systems
- Provide QA review and approval of validation deliverables
- Apply a risk-based, critical-thinking approach to focus assurance effort
- Provide quality oversight of system lifecycle activities
- Ensure systems meet data integrity and electronic records requirements
Requirements
- Bachelor's degree in Life Sciences, Computer Science, Engineering, Information Systems, or a related field
- Nice to have: CSA principles
- Nice to have: AI/ML tool validation
- Nice to have: ISPE GAMP AI guidance
- Nice to have: FDA AI guidance