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 will be 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 Develop UAT strategies, test plans, scripts, and acceptance criteria aligned with business and regulatory requirements Partner with laboratory stakeholders to ensure test scenarios reflect real-world workflows and operational use cases Facilitate defect tracking, triage, and resolution in collaboration with IT and vendors Ensure traceability between requirements, test cases, and outcomes System Validation & Compliance Plan and execute system validation activities in accordance with regulatory standards (e.g., GxP, FDA 21 CFR Part 11, CLIA, CAP) Author and/or review validation deliverables, including: Validation Plans (VP) Requirements Specifications (URS/FRS) Risk Assessments IQ/OQ/PQ protocols and reports Traceability matrices Ensure systems are audit-ready and compliant with internal quality systems and external regulatory expectations Support audit and inspection activities, including responses and corrective actions Regulatory Documentation & Quality Support Develop and maintain SOPs, work instructions, and supporting documentation related to laboratory systems and processes Ensure documentation aligns with quality management system (QMS) requirements Collaborate with Quality Assurance to maintain compliance and support continuous improvement initiatives Maintain document control and versioning in accordance with regulatory standards Business Analysis & Stakeholder Engagement Gather, analyze, and document business and functional requirements from laboratory stakeholders