Principal QA Validation Specialist (CSV)

Role Summary

We are hiring a Principal QA Validation Specialist to support validation and qualification of computer systems within IOPS. The Principal QA Validation Specialist would also plan, coordinate and participate in compliant computer system validation (CSV) process for systems which require formal validation documentation in accordance with regulatory and company manufacturing standards.

Responsibilities

• Generates, executes and/or reviews master and completed computer system(s) qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
• Analyzes the results of testing and settles acceptability of results against pre-determined criteria
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements
• Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions
• Reviews, edits and approves change controls, SOPs, reports and other documentation
• Coordinates with other departments or outside contractors/vendors to complete validation tasks
• Trains/advises less experienced Specialists
• Leads projects and prepares status reports
• May be required to oversee contingent workers

Qualifications

• Required: BS/BA in Engineering, Chemistry, Life Sciences, Computer Science, IT or related field
• Required: 8+ years of experience for Principal QA Validation Specialist (or equivalent) or 5+ years for Sr. QA Validation Specialist; level determined by qualifications relevant to the role
• May substitute proven experience for education requirement
• Knowledge in GAMP, 21 CFR PART 11, Annex 11

Education

• BS/BA in Engineering, Chemistry, Life Sciences, Computer Science, IT or related field