GxP Systems Administrator

Job Summary

Responsible for the lifecycle administration of GxP and Quality governed systems, the full-time remote GxP Systems Administrator will manage applications such as eQMS and CMMS, perform user account administration, and ensure compliance with regulatory requirements.

Key Responsibilities:

• Administer GxP applications, including Dot Compliance eQMS and Master Control CMMS
• Manage system configuration, upgrades, and patches while maintaining validated system states
• Support internal audits and regulatory inspections, ensuring compliance with FDA regulations and quality management systems

Required Qualifications:

• Bachelor's degree in Information Technology, Computer Science, Life Sciences, or related field, or equivalent experience
• 3-5+ years of experience administering IT systems and providing technical support
• 2+ years of experience with GxP-regulated systems in a regulated environment
• Working knowledge of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5
• Experience with change management and quality-related procedures