Clinical Lab Information Specialist

Precision Medicine Group•Frederick, MD

11d•$83,200 - $124,800•Onsite

About The Position

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).

Requirements

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

Nice To Haves

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

Responsibilities

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
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
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
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
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