Clinical Lab Information Specialist

Job Summary:

The Clinical Lab Information Specialist plays a critical role in supporting laboratory technology initiatives with a strong emphasis on User Acceptance Testing (UAT), system validations, and regulatory compliance documentation. This position serves as a key liaison between laboratory operations, IT, quality, and external vendors to ensure that laboratory systems are implemented, validated, and maintained in accordance with regulatory standards and business needs. This position is fully onsite at our Frederick, MD location. 

The ideal candidate combines deep clinical laboratory knowledge with expertise in system implementation, validation methodologies, and regulatory documentation within a highly controlled environment (e.g., CLIA, CAP, FDA, GxP).

Main Duties & Responsibilities: 

Essential duties include but are not limited to:

UAT Leadership & Execution

• Lead and coordinate User Acceptance Testing (UAT) activities for laboratory information systems (LIS), middleware, instrumentation interfaces, and other clinical lab technologies
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