Senior Laboratory Application Support Specialist
On-siteDurham, North Carolina, United States or Burlington, North Carolina, United States
Job Summary
Maintain up-time, user access, and overall stability for LIS/LIMS platforms and middleware while troubleshooting complex application bugs, system errors, and data transmission failures. Manage the application support ticket queue, prioritizing business-critical issues, and act as the primary liaison between laboratory operations, corporate IT, and third-party software vendors. Configure analytical test profiles, workflow rules, and reporting formats, and build HL7 data exchange interfaces between laboratory applications and Electronic Health Records. Lead Computer System Validation efforts, including writing and executing IQ/OQ/PQ protocols, and ensure strict compliance with regulatory standards such as FDA 21 CFR Part 11, GxP, HIPAA, and CAP. Drive application life cycle projects, conduct end-to-end regression testing for software updates, and deliver training materials for laboratory clinicians and technicians.
Required Qualifications
- Bachelor's Degree
- Five or more years of hands-on experience supporting clinical LIS or scientific LIMS applications
Desired Qualifications
- Five or more years of experience working in a heavily regulated environment in either healthcare, pharmaceuticals, or biotech
- Five or more years of experience with HL7 standards, interface messaging protocols, and TCP/IP data routing
- Five or more years of experience administering laboratory middleware architecture
- Three or more years of experience writing database queries (SQL) for custom data extraction and reporting
- Three or more years of experience with computer systems validation frameworks
- Exceptional analytical and problem-solving skills under high-pressure clinical deadlines
- Strong verbal and written communication skills to bridge technical IT concepts with clinical personnel
- Project management capabilities to balance daily production tickets alongside long-term strategic projects
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