Systems Administrator, Electronic GxP Systems

Responsibilities

• Serve as the system administrator and execution owner for all electronic GxP systems and GxP supporting applications
• Maintain a complete and current inventory of electronic GxP and GxP-supporting systems
• Ensure all applicable systems are appropriately classified for GxP impact, validated, and maintained in a validated state
• Configure, maintain, and execute system workflows and forms
• Control system changes in accordance with validation requirements
• Provide quality system execution oversight for GxP-supporting applications
• Develop, maintain, and execute system-level reports while ensuring system data is accurate and compliant
• Manage system-level inspections and support internal audits and regulatory inspections

Requirements

• Bachelor’s or Master's degree in a scientific, technical, or information systems-related discipline
• Minimum 6+ years of experience supporting Quality Assurance systems in a regulated pharmaceutical, biotechnology, medical device, or combination product environment
• Demonstrated hands-on experience administering electronic GxP systems
• Proven experience supporting validated system lifecycles
• Strong proficiency with Microsoft 365 and system reporting tools