Clinical Lab Information Specialist
$83,200–$124,800 year
On-siteFrederick, Maryland, United States
Job Summary
Lead User Acceptance Testing (UAT) for laboratory information systems, middleware, and instrumentation interfaces by developing test strategies, scripts, and acceptance criteria aligned with regulatory requirements. Plan and execute system validation activities in accordance with GxP, FDA 21 CFR Part 11, CLIA, and CAP standards, authoring validation plans, risk assessments, and IQ/OQ/PQ protocols to ensure audit readiness. Gather and document business requirements from laboratory stakeholders, translating complex workflows into technical specifications while serving as a liaison between operations, IT, and vendors. Develop and maintain standard operating procedures, work instructions, and document control systems to support continuous quality improvement. Fully onsite at the Frederick, MD location.
Required Qualifications
- Bachelor's Degree or Master Degree in Clinical Laboratory Science, Life Sciences, Health Informatics, or related field
- 5-8 years of related experience in clinical laboratory operations, laboratory informatics, or business analysis
- Strong experience with laboratory systems (LIS, LIMS, middleware, instrument interfaces)
- Demonstrated expertise in UAT coordination and execution
- Hands-on experience with system validation in regulated environments (GxP, CLIA, CAP, FDA)
- Experience authoring validation and regulatory documentation
- This position will be fully onsite at our Frederick, MD location
Desired Qualifications
- Experience with specific LIS platforms (e.g., Epic Beaker, SCC Soft, Sunquest, Cerner Millennium)
- Familiarity with data standards (HL7, interfaces, instrument connectivity)
- Experience in audit/inspection readiness and regulatory submissions
- Knowledge of electronic document management systems (eDMS) and change control processes
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