GxP Systems Lifecycle Administrator & QA Support

CAI; United States; Remote; USD 130,000 - 150,000; Full time

Benefits offered by this job

Health Insurance

Paid Time Off

Life Insurance

Long Term Disability

Job summary

CAI is seeking a GxP Systems and Support Administrator to oversee eQMS, CMMS, Kneat and Valkit within the IT & Information Security team. You will manage lifecycle administration, access controls, validation, and change control while collaborating with Digital & Quality teams to ensure regulatory compliance.

Responsibilities include supporting CSA activities, audits, CAPA, and technical investigations, plus training end users on system functionality and compliance requirements.

Qualifications

• Bachelor’s degree or equivalent experience in IT/related field.
• 3–5+ years of IT systems administration and technical support.
• 2+ years administering GxP-regulated systems in regulated environments.
• Experience with validated computer systems lifecycle management.
• Familiar with FDA 21 CFR Part 11, EU Annex 11, and GDP.
• Collaborates with Security & Quality teams to ensure compliance.
• Experience with change control, investigations, deviations and QA procedures.
• Experience with Entra, SSO/SCIM, backups, DR procedures.
• Strong troubleshooting, documentation, and cross-team communication.

Responsibilities

• Administer GxP apps including eQMS, CMMS, Kneat & Valkit.
• Manage user accounts, RBAC, and access reviews.
• Configure, upgrade, and patch systems per change control.
• Maintain validated state with proper documentation and procedures.
• Deploy project-based Digital Validation instances for clients.
• Support CSA activities, vendor testing reviews, and validation docs.
• Contribute to risk assessments and validation impact analyses.
• Document changes per QMS requirements and investigate incidents.
• Assist audits and CAPA with technical analysis and actions.
• Provide end-user training on system use and compliance.

Skills

IT systems admin

GxP systems

FDA 21 CFR 11

Data Integrity GDP

Change management

Entra identity

SSO SCIM

Cross-functional

Documentation

Audit support

Education

Bachelor’s degree in IT/CS

Tools

eQMS

CMMS

Kneat

Valkit

Job description

CAI is seeking a GxP Systems and Support Administrator to oversee eQMS, CMMS, Kneat and Valkit within the IT & Information Security team. You will manage lifecycle administration, access controls, validation, and change control while collaborating with Digital & Quality teams to ensure regulatory compliance.

Responsibilities include supporting CSA activities, audits, CAPA, and technical investigations, plus training end users on system functionality and compliance requirements.