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CAIGxP Systems and Support Administrator
CAI seeks a GxP Systems and Support Administrator to join its integrated IT and Information Security team, with reporting responsibilities extending to the Digital and Quality…
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About This Role
CAI seeks a GxP Systems and Support Administrator to join its integrated IT and Information Security team, with reporting responsibilities extending to the Digital and Quality teams. Founded in 1996, CAI is a professional services organization employing nearly 800 staff worldwide, delivering operational readiness and technical solutions to mission-critical and regulated industries. In this position, the administrator oversees the full lifecycle of GxP and Quality-governed platforms, including digital validation tools,…
Job Description
CAI seeks a GxP Systems and Support Administrator to join its integrated IT and Information Security team, with reporting responsibilities extending to the Digital and Quality teams. Founded in 1996, CAI is a professional services organization employing nearly 800 staff worldwide, delivering operational readiness and technical solutions to mission-critical and regulated industries. In this position, the administrator oversees the full lifecycle of GxP and Quality-governed platforms, including digital validation tools, computerized maintenance management systems, and electronic quality management systems.
The successful candidate will manage system configurations, handle user account access, maintain validated states, and participate in Computer Software Assurance activities. Responsibilities also encompass executing change controls, addressing system deviations, supporting audits, and resolving technical inquiries. This role suits professionals experienced in regulated environments who possess a background in information technology administration and quality compliance.
Employment is full-time on-site, offering a yearly salary between $130,000 and $150,000. CAI provides a benefits package that includes medical insurance, 24 days of paid time off, life insurance, and long-term disability coverage. The organization operates as an equal opportunity employer valuing workplace diversity.
Responsibilities
- Administer GxP applications including Dot Compliance eQMS, Master Control CMMS, Kneat, and Valkit Digital Validation Applications.
- Handle user account creation, role-based access control, and periodic access reviews.
- Oversee system configurations, upgrades, and patches following change control and validation protocols.
- Maintain the validated state of systems through accurate documentation and adherence to procedures.
- Deploy and manage project instances of Digital Validation applications for client services.
- Support Computer Software Assurance tasks such as vendor testing package reviews, ad hoc testing, and acceptance testing.
- Participate in drafting and approving validation documents, SOPs, training materials, and technical guides.
- Conduct risk assessments, validation impact assessments, and manage system change controls.
- Investigate, troubleshoot, and resolve software incidents, deviations, and user reported issues.
- Contribute to CAPA investigations by supplying technical analysis and corrective actions.
- Assist with internal, supplier, customer, and regulatory audits or inspections.
- Ensure audit trails, electronic records, and electronic signatures align with regulatory standards.
- Collaborate with software vendors to correct bugs and deploy approved updates.
- Provide Tier 1 and Tier 2 technical support for relevant systems.
- Contribute to cybersecurity efforts for regulated platforms, such as vulnerability remediation and security monitoring.
- Train end users on software functionality and compliance rules.
Requirements
- 3 to 5 plus years of experience administering IT systems and delivering technical support.
- 2 plus years of experience administering GxP-regulated systems within pharmaceutical, biotechnology, medical device, or similar regulated sectors.
- Experience maintaining validated computer systems across their lifecycle.
- Working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity or Good Documentation Practices.
- Experience collaborating with Information Security and Quality departments.
- Familiarity with change management, investigations, and quality procedures.
- Experience utilizing Entra identity management, access controls, SSO, and SCIM integrations.
- Knowledge of backup, recovery, and disaster recovery processes.
Qualifications
- Bachelor degree in Information Technology, Computer Science, Life Sciences, or a related field, or equivalent experience.
- Prior experience administering CMMS, DVT, or eQMS platforms in a GxP environment.
- Background in GxP or Quality systems administration within a professional services or consulting firm.
Core Skills
Benefits
- Comprehensive Health Insurance coverage
- 24 days of Paid Time Off
- Company paid Life Insurance
- Company paid Long Term Disability
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
What is the salary for this position?
The average base salary range is between USD 130,000 and 150,000 per year, not including benefits.
What is the employment type and remote status?
The position is full-time and on-site.
Where is the job located?
The specific job location is not stated in the posting.
What benefits are provided by the employer?
Benefits include comprehensive health insurance, 24 days of paid time off, company-paid life insurance, and company-paid long-term disability.
Sample Interview Questions
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