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 SummaryThe 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 Responsibilities1. Technical Support & TroubleshootingProvide 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 AdministrationInstall, 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 ComplianceEnsure 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 & SecurityMonitor 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 & ProjectsPartner 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.QualificationsEducation & Experience:Associate's or Bachelor's degree in Information Technology, Computer Science, or related field preferred.2 years of experience in IT support or system administration, preferably in a pharmaceutical, biotech, or GMP-regulated environment.Skills & Competencies:Significant GMP experienceStrong knowledge of Windows operating systems, Microsoft 365, and networking fundamentals.Experience with Active Directory, file permissions, and group policies.Familiarity with ERP, LIMS, MES, or other laboratory/manufacturing systems (preferred).Understanding of GMP, 21 CFR Part 11, and data integrity requirements (preferred).Excellent troubleshooting, communication, and customer service skills.Ability to handle multiple priorities in a fast-paced, regulated environment.Preferred Certifications:CompTIA A (IT support fundamentals)CompTIA Network (networking basics)HDI Support Center Analyst (HDI-SCA) or HDI Desktop Support Technician (HDI-DST)Microsoft Certified: Modern Desktop Administrator AssociateITIL® Foundation (IT service management best practices)Physical RequirementsAbility to lift up to 25 lbs. for equipment installation.Ability to sit or stand for extended periods.Occasional after-hours or weekend work to support system maintenance or project deadlines.Work EnvironmentOffice and manufacturing/laboratory settings with exposure to cleanroom environments.Strict adherence to company safety, security, and GMP policies is required.Compensation depends on experience but is typically 75,000-90,000ABOUT KORE1Specializing in professional and technical recruiting, KORE1 is committed to supporting top IT, Engineering, Creative, Scientific, Accounting and Finance professionals in their career paths. We build deep relationships with leading companies, connecting them to exceptional talent every day. With extensive industry expertise and unmatched opportunities, our goal is to provide a unique experience for our contractors and consultants as they prepare for their next role. We are passionate about matching the right people with the right companies.Kore1 provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Kore1 complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Kore1 expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Kore1's employees to perform their job duties may result in discipline up to and including discharge.