IT Specialist

IT Specialist

KORE1, a nationwide provider of staffing and recruiting solutions, has an immediate opening for an IT Specialist for the Costa Mesa location.

Position Summary

The IT Specialist is responsible for providing technical support, system administration, and infrastructure maintenance in a GMP-compliant pharmaceutical CDMO environment. This role ensures the secure, reliable, and compliant operation of all IT systems, networks, and applications that support manufacturing, laboratory, and business operations. The IT Specialist will collaborate closely with Quality Assurance, Production, and R&D to ensure all IT solutions meet both operational needs and regulatory requirements.

Key Responsibilities

1. Technical Support & Troubleshooting

• Provide timely end-user support for hardware, software, and network issues.
• Diagnose, troubleshoot, and resolve incidents via phone, email, remote tools, and in person.
• Escalate complex issues to senior IT staff or vendors as necessary.

2. System Administration

• Install, configure, and maintain workstations, servers, printers, and mobile devices.
• Administer Active Directory, email systems, user accounts, and permissions.
• Manage and maintain data backup, disaster recovery, and storage solutions.

3. GMP & Regulatory Compliance

• Ensure all IT systems and processes comply with GMP, FDA, and other applicable regulatory guidelines.
• Support Computer System Validation (CSV) activities, including documentation, change control, and periodic reviews.
• Maintain detailed records of system configurations, updates, and incidents in compliance with audit requirements.

4. Network & Security

• Monitor and maintain LAN/WAN, wireless networks, and internet connectivity.
• Apply security updates, patches, and antivirus protection.
• Assist in implementing cybersecurity best practices and incident response procedures.

5. Collaboration & Projects

• Partner with cross-functional teams to support IT requirements for manufacturing, laboratory, and administrative operations.
• Assist in planning and executing IT infrastructure upgrades, migrations, and implementations.
• Provide technical input during audits, inspections, and customer visits as needed.