GxP Systems and Support Administrator

CAI

. Administer GxP applications supporting infrastructure, including Dot Compliance eQMS, Master Control CMMS, Kneat, and Valkit Digital Validation Applications .

Posted 10/2/2026full-timeRemote • United StatesJuniorMid-Level💰 $130,000 - $150,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in administering GxP applications and validated computer systems, ensuring compliance with regulatory requirements and quality standards. Proficient in managing system configurations, conducting audits, and providing technical support in regulated environments.

Highest-signal resume keywords

GxP Systems AdministrationValidation Documentation CreationChange ManagementFDA 21 CFR Part 11 KnowledgeTechnical Support Experience

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

System Configuration ManagementUser Account AdministrationValidation ProceduresTroubleshootingRisk AssessmentChange Control ExecutionIncident InvestigationData Integrity PracticesBackup and Recovery ProceduresCybersecurity Initiatives

Soft Skills

Strong Communication SkillsAnalytical SkillsCollaboration with Cross-Functional Teams

Tools & Technologies

Dot Compliance eQMSMaster Control CMMSKneatValkit Digital Validation ApplicationsEntra Identity Management

Industry Keywords

GxPQuality SystemsRegulatory CompliancePharmaceuticalBiotechnologyMedical DeviceGood Documentation PracticesSystem Acceptance TestingUser Acceptance TestingCAPA Investigations

Tech Stack

Tools & technologies

Cyber Security

About the role

Key responsibilities & impact

Administer GxP applications supporting infrastructure, including Dot Compliance eQMS, Master Control CMMS, Kneat, and 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 and validation processes
Maintain validated system state through documentation and validation procedures
Deploy and manage project-based instances of Digital Validation applications to support client services
Support Computer Software Assurance activities, including vendor testing package reviews, ad hoc testing, System Acceptance Testing, User Acceptance Testing, and Periodic Reviews
Create, review, and approve 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 according to QMS requirements
Investigate, troubleshoot, and resolve system incidents, deviations, and user-reported issues
Support CAPA investigations through technical analysis and corrective actions
Support internal, supplier, customer, and regulatory audits and 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 and Tier 2 technical support for applicable systems
Assist with cybersecurity initiatives for regulated systems, including vulnerability remediation, security monitoring, and entitlement reviews
Train end users on system functionality and compliance requirements

Requirements

What you’ll need

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
Preferred: Experience administering CMMS, DVT or eQMS platforms in GxP environment
Preferred: Experience in GxP or Quality systems administration within a Professional Services or consulting organization

Benefits

Comp & perks

Comprehensive Health Insurance coverage
24 days of Paid Time Off
Company paid Life Insurance
Company paid Long Term Disability