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
• 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:

• Bachelors 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

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