Lab Informatics & UAT Lead for Regulated Systems

Precision Medicine Group; Frederick (MD); On-site; USD 83,000 - 125,000; Full time

Benefits offered by this job

Discretionary bonus

Health insurance

Retirement savings

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

The Clinical Lab Information Specialist at Precision Medicine Group plays a pivotal role in supporting laboratory technology initiatives with a strong emphasis on UAT, system validations, and regulatory documentation. This onsite role in Frederick, MD fosters collaboration between laboratory operations, IT, quality, and external vendors to ensure compliant implementations.

The ideal candidate combines deep clinical laboratory knowledge with expertise in validation methodologies and regulatory

Qualifications

• Bachelor’s or Master in Clinical Laboratory Science / Life Sciences / Health Informatics
• 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)

Responsibilities

• Lead and coordinate 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 (GxP, FDA 21 CFR Part 11, CLIA, CAP)
• Author and/or review validation deliverables, including VP, URS/FRS, Risk Assessments, IQ/OQ/PQ, and reports
• 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
• Collaborate with Quality Assurance to maintain compliance and support continuous improvement initiatives

Job description

The Clinical Lab Information Specialist at Precision Medicine Group plays a pivotal role in supporting laboratory technology initiatives with a strong emphasis on UAT, system validations, and regulatory documentation. This onsite role in Frederick, MD fosters collaboration between laboratory operations, IT, quality, and external vendors to ensure compliant implementations.

The ideal candidate combines deep clinical laboratory knowledge with expertise in validation methodologies and regulatory