GxP Lab Instrument Applications Support Specialist

USDM Life Sciences; Holly Springs (NC); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401k plan

Job summary

USDM Life Sciences is seeking a Lab Instrument Applications Support professional in Holly Springs, NC to uphold Windows-based instrument software in a regulated setting.

You will manage instrument control apps, maintain validated systems, and provide user support with robust documentation, training materials, and audit-ready records. This role requires collaboration with QA, IT, and vendors to ensure compliance and reliability.

Qualifications

• Bachelor’s degree in Computer Science or Information Systems or related field required.
• 2 years administering lab instrument applications in GxP settings.
• Hands-on with ALCOA+, Part 11/Annex 11, audit trails and e-signatures.

Responsibilities

• Provide hands-on support for instrument software and instrument PCs in a regulated environment.
• Maintain validated state, documentation, and data integrity across systems.
• Triage tickets, perform root-cause analysis, and escalate to vendors as needed.
• Coordinate firmware updates and software patches under change control.
• Support IQ/OQ/PQ activities with vendors and QA teams.
• Develop admin SOPs, configuration specs, and data flow diagrams.
• Ensure audit trails, access controls, and electronic signatures are properly configured.

Skills

Windows Administration

GxP Compliance

ALCOA+ & Audit Trails

On-call Support

Vendor Coordination

Education

Bachelor’s degree in Computer Science or Information Systems

Master’s Degree preferred

Tools

PowerShell

ServiceNow

Jira

SDMS

Job description

USDM Life Sciences is seeking a Lab Instrument Applications Support professional in Holly Springs, NC to uphold Windows-based instrument software in a regulated setting.

You will manage instrument control apps, maintain validated systems, and provide user support with robust documentation, training materials, and audit-ready records. This role requires collaboration with QA, IT, and vendors to ensure compliance and reliability.