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
• 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
• Translate complex laboratory workflows into system requirements and technical specifications
• Serve as a liaison between laboratory operations, IT, vendors, and quality teams
• Facilitate workshops, meetings, and process mapping sessions

System Implementation & Optimization

• Support system implementation, upgrades, and enhancements across laboratory platforms
• Identify opportunities to improve efficiency, data integrity, and compliance through system optimization
• Provide subject matter expertise on laboratory processes, informatics, and regulatory expectations

Education & Experience:

Minimum Education & Experience:

• Bachelor’s Degree or Master Degree in Clinical Laboratory Science, Life Sciences, Health Informatics, or related field required
• 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

Preferred Education & Experience (optional):

• 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