Job Application for Clinical Lab Information Specialist at Precision Medicine Group

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
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

Precision 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 USD

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Clinical Lab Information Specialist

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