The opportunity
Computer System Validation Specialist will work the Natera Software Engineering team to ensure appropriate software documentation is in place to support changes to Laboratory and Product software systems. Working with the QA Software Manager this position will provide…
What you'll do
Perform risk and/or impact assessments for Lab, Product, and Quality Management software systems
Review software change requests and maintenance updates along with associated: test plans, protocols, and reports
Draft IQ/OQ/PQ software plans, protocols, and reports
Ensure validation state of software systems are maintained
Act as subject matter expert for CSV compliance during internal and external audits
Perform audit trail reviews
What they're looking for
- BS Degree or equivalent work experience
- years’ experience within a dedicated CSV or product software validation role
- Experienced working in a CLIA Laboratory environment and/or FDA regulated environment
- Preferred experience/knowledge with Microsoft Great Plains, Confluence, JIRA, SuccessFactors, LIMS, EDMS