Onsite address: 1890 Rutherford Rd Ste 200, Carlsbad, CA
Ideal Candidate will have the following Lab Support Experience:
- Understand and follow GxP, GmP and GDP Practices.
- Ensure all quality standards are met to comply with FDA, EMA and CDC standards.
- End User Support Experience
Minimum Required Experience
- 1–2 years of experience supporting a GxP environment
- Hands-on Desktop Support experience with Manufacturing/Lab IT support experience
- Exposure to Computer System Validation (CSV) processes
- Strong documentation and compliance mindset
- Self-motivated with the ability to work independently onsite
Nice-to-Have / Additional Technical Skills
- Solid knowledge of Windows OS (Win10 preferred, Win7 supported)
- Proficiency in Microsoft Office Suite: Word, Excel, Outlook, SharePoint, Skype, Calendar
- Hands-on hardware troubleshooting experience
- Ability to read and understand technical manuals, procedural documentation, and OEM guides
- Familiarity with Active Directory for computer configuration and account management
- Understanding of network basics: LAN/WAN, DNS, proxy servers, firewalls, VPN
- Knowledge of software distribution, patching, and imaging technologies
- Knowledge of IMAC, SLA's, and ITIL practices
- Support for mobile devices, VPN, and remote collaboration tools
- Experience creating build records, backups, and account logs
- Ability to assist with vendor coordination and implementation of lab devices
- Understanding of IQ/OQ activities and lab automation support
- Use of tools like COMAP for patch management and lab device updates
Key Responsibilities
- Troubleshoot technical issues with hardware, software, or systems to ensure smooth operations.
- Support systems in a regulated/compliance-focused environment (GxP, SOPs, CSV, or equivalent).
- Maintain proper documentation and change control for systems and procedures.
- Collaborate with cross-functional teams, including IT, quality, operations, and engineering.
- Maintain and manage system inventories, assets, or equipment records.
- Contribute to operational efficiency and support continuous improvement initiatives.
- Implement and update standard operating procedures (SOPs) or internal documentation to comply with standards.