• Develop and manage GxP system lifecycle documentation, including Validation Plans, Testing Protocols, Traceability Matrix, Validation Reports
• Work closely and communicate with project teams to analyze requirements and build test protocols
• Author and execute test protocols to support computer system validation using HP Quality Center
• Document bugs/defects using HP Quality Center
• Follow FDA 21 CFR Part 11 regulations, GxP regulations, AbbVie policies/ procedures, GAMP5 best practices

• Proficient in the use of HP Quality Center
• Communicate issues that could impact scope or timeline to validation team leadership
• Complete all assigned training prior to due dates
• Is detail oriented
• Works under general supervision; typically reports to a manager
• Enter project task time in Clarity
• Requires a bachelor’s degree and 4-7 years of experience