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 & ExecutionLead and coordinate User Acceptance Testing (UAT) activities for laboratory information systems (LIS), middleware, instrumentation interfaces, and other clinical lab technologiesDevelop UAT strategies, test plans, scripts, and acceptance criteria aligned with business and regulatory requirementsPartner with laboratory stakeholders to ensure test scenarios reflect real-world workflows and operational use casesFacilitate defect tracking, triage, and resolution in collaboration with IT and vendorsEnsure traceability between requirements, test cases, and outcomesSystem Validation & CompliancePlan 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 AssessmentsIQ/OQ/PQ protocols and reportsTraceability matricesEnsure systems are audit-ready and compliant with internal quality systems and external regulatory expectationsSupport audit and inspection activities, including responses and corrective actionsRegulatory Documentation & Quality SupportDevelop and maintain SOPs, work instructions, and supporting documentation related to laboratory systems and processesEnsure documentation aligns with quality management system (QMS) requirementsCollaborate with Quality Assurance to maintain compliance and support continuous improvement initiativesMaintain document control and versioning in accordance with regulatory standardsBusiness Analysis & Stakeholder EngagementGather, analyze, and document business and functional requirements from laboratory stakeholdersTranslate complex laboratory workflows into system requirements and technical specificationsServe as a liaison between laboratory operations, IT, vendors, and quality teamsFacilitate workshops, meetings, and process mapping sessionsSystem Implementation & OptimizationSupport system implementation, upgrades, and enhancements across laboratory platformsIdentify opportunities to improve efficiency, data integrity, and compliance through system optimizationProvide subject matter expertise on laboratory processes, informatics, and regulatory expectationsEducation & Experience:Minimum Education & Experience: Bachelor’s Degree or Master Degree in Clinical Laboratory Science, Life Sciences, Health Informatics, or related field required5-8 years of related experience in clinical laboratory operations, laboratory informatics, or business analysisStrong experience with laboratory systems (LIS, LIMS, middleware, instrument interfaces)Demonstrated expertise in UAT coordination and executionHands-on experience with system validation in regulated environments (GxP, CLIA, CAP, FDA)Experience authoring validation and regulatory documentationPreferred 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 submissionsKnowledge of electronic document management systems (eDMS) and change control processesPrecision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$83,200—$124,800 USDAny data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at View email address on us.fitly.work Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. 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