Lab Informatics UAT Lead & System Validation

Precisionmedicinegroup; Frederick (MD); On-site; USD 83,200 - 124,800; Full time

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement savings

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group in Frederick, MD is seeking a Clinical Lab Information Specialist to lead UAT, run system validations, and maintain regulatory documentation for our laboratory information systems. This on-site role requires collaboration with Laboratory Operations, IT, Quality, and external vendors to ensure compliant, validated LIS/LIMS implementations.

The ideal candidate has deep clinical lab knowledge, hands-on validation experience in regulated environments, and a track record of

Qualifications

• Bachelor’s or Master degree in Clinical Laboratory Science, Life Sciences, Health Informatics, or related field.
• 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 LIS, middleware, interfaces, and other clinical lab technologies.
• Develop UAT strategies, test plans, scripts, and acceptance criteria.
• Partner with laboratory stakeholders to reflect real-world workflows and use cases.
• Facilitate defect tracking and traceability between requirements, tests, and outcomes.
• Plan and execute system validation activities per regulatory standards.
• Author and review validation deliverables and regulatory documentation.
• Maintain audit-ready documentation and support audits/inspections.

Skills

UAT coordination

LIS/LIMS experience

Regulatory documentation

Stakeholder engagement

Regulatory compliance

System implementation

Education

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

Tools

LIS/LIMS

Middleware

Instrument interfaces

Job description

Precision Medicine Group in Frederick, MD is seeking a Clinical Lab Information Specialist to lead UAT, run system validations, and maintain regulatory documentation for our laboratory information systems. This on-site role requires collaboration with Laboratory Operations, IT, Quality, and external vendors to ensure compliant, validated LIS/LIMS implementations.

The ideal candidate has deep clinical lab knowledge, hands-on validation experience in regulated environments, and a track record of