Clinical Lab Information Specialist

<p><span style="text-decoration: underline;"><strong>Job Summary:</strong></span></p> <p>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. <strong>This position is fully onsite at our Frederick, MD location.&nbsp;</strong></p> <p>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).</p> <p><span style="text-decoration: underline;"><strong>Main Duties &amp; Responsibilities:&nbsp;</strong></span></p> <p>Essential duties include but are not limited to:</p> <p><strong>UAT Leadership &amp; Execution</strong></p> <ul> <li>Lead and coordinate User Acceptance Testing (UAT) activities for laboratory information systems (LIS), middleware, instrumentation interfaces, and other clinical lab technologies</li> <li>Develop UAT strategies, test plans, scripts, and acceptance criteria aligned with business and regulatory requirements</li> <li>Partner with laboratory stakeholders to ensure test scenarios reflect real-world workflows and operational use cases</li> <li>Facilitate defect tracking, triage, and resolution in collaboration with IT and vendors</li> <li>Ensure traceability between requirements, test cases, and outcomes</li> </ul> <p><strong>System Validation &amp; Compliance</strong></p> <ul> <li>Plan and execute system validation activities in accordance with regulatory standards (e.g., GxP, FDA 21 CFR Part 11, CLIA, CAP)</li> <li>Author and/or review validation deliverables, including:</li> <ul> <li>Validation Plans (VP)</li> <li>Requirements Specifications (URS/FRS)</li> <li>Risk Assessments</li> <li>IQ/OQ/PQ protocols and reports</li> <li>Traceability matrices</li> </ul> <li>Ensure systems are audit-ready and compliant with internal quality systems and external regulatory expectations</li> <li>Support audit and inspection activities, including responses and corrective actions</li> </ul> <p><strong>Regulatory Documentation &amp; Quality Support</strong></p> <ul> <li>Develop and maintain SOPs, work instructions, and supporting d