CAI - GxP Systems and Support Administrator

United States$130k - $150k3w ago

In Office Mid NA Medical Devices Pharmaceuticals Support Manager Systems Administrator Documentation Benefits Administration Reporting CAIA Change Management

Requirements

• 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 administering GxP-regulated systems in a pharmaceutical, biotechnology, medical device, or related regulated environment. • Experience supporting validated computer systems throughout their lifecycle. • Working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity / Good Documentation Practices (GDP). • Experience collaborating with Information Security & Quality departments to ensure system compliance with internal and regulatory requirements. • Experience with change management, investigations, deviations and other Quality-related procedures. • Experience with Entra identity management, access controls, SSO & SCIM integrations. • Knowledge of backup, recovery, and disaster recovery procedures. • Excellent troubleshooting, analytical, and documentation skills. • Strong communication skills and ability to work with cross-functional teams. • Experience administering CMMS, DVT or eQMS platforms in GxP environment • Experience in GxP or Quality systems administration within a Professional Services or consulting organization • $130,000 - $150,000 a year • Average base salary range - not including benefits.

Responsibilities

• Administer GxP applications supporting infrastructure: Dot Compliance eQMS, Master Control CMMS, Kneat & Valkit Digital Validation Applications. • Perform user account administration, role-based access control, and periodic access reviews. • Manage system configuration, upgrades, and patches using established change control & validation processes. • Maintain validated system state through proper documentation and adherence to validation procedures. • Deploy & manage project-based instances of Digital Validation applications to support client services. • Support Computer Software Assurance (CSA) activities including review of vendor testing packages, documented ad hoc testing, execution of System Acceptance Testing and User Acceptance Testing and Periodic Reviews. Periodic Reviews • Participate in the creation, review, and approval of validation documentation, SOPs, work instructions, training materials / requirements, and technical documentation. • Participate in risk assessments and validation impact assessments for system changes. • Execute and document system change controls in accordance with Quality Management System (QMS) requirements. • Investigate, troubleshoot, and resolve system incidents, deviations, and user-reported issues. • Support CAPA investigations by providing technical analysis and implementing corrective actions. • Support internal audits, supplier audits, customer audits, and regulatory inspections. • Ensure audit trails, electronic records, and electronic signatures comply with regulatory requirements. • Collaborate with vendors to resolve software defects and implement approved upgrades. • Manage Tier 1 & 2 technical support for applicable systems. • Assist in cybersecurity initiatives for regulated systems, including vulnerability remediation, security monitoring and entitlement reviews. • Train end users on system functionality and compliance requirements.