Onsite Lab Informatics & UAT Validation Specialist

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

Benefits offered by this job

Discretionary bonus

Health insurance

Retirement benefits

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group is seeking a Clinical Lab Information Specialist to lead UAT for laboratory systems and ensure validated, compliant deployments onsite at our Frederick, MD facility. This role requires strong collaboration across Laboratory Operations, IT, Quality, and external vendors to maintain audit-ready systems under CLIA, CAP, FDA frameworks.

The ideal candidate combines deep clinical lab knowledge with experience in validation methodologies and regulatory documentation within

Qualifications

• Bachelor’s or Master’s 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.

Responsibilities

• Lead and coordinate UAT activities for LIS, middleware, interfaces, and other clinical lab technologies.
• Develop UAT strategies, test plans, scripts, and acceptance criteria aligned with regulatory requirements.
• Partner with laboratory stakeholders to reflect real-world workflows in test scenarios.
• Facilitate defect tracking, triage, and resolution with IT and vendors.
• Ensure traceability between requirements, test cases, and outcomes.
• Plan and execute system validation activities per regulatory standards (GxP, FDA 21 CFR Part 11, CLIA, CAP).
• Author/review validation deliverables (URS/FRS, IQ/OQ/PQ, reports).
• Maintain SOPs and quality documentation aligned with QMS.

Skills

UAT coordination

Regulatory documentation

LIS/LIMS knowledge

GxP compliance

Stakeholder engagement

Regulatory audits

Validation expertise

Documentation control

Education

Clinical Laboratory Science

Life Sciences

Health Informatics

Tools

Epic Beaker

SCC Soft

Sunquest

Cerner Millennium

Job description

Precision Medicine Group is seeking a Clinical Lab Information Specialist to lead UAT for laboratory systems and ensure validated, compliant deployments onsite at our Frederick, MD facility. This role requires strong collaboration across Laboratory Operations, IT, Quality, and external vendors to maintain audit-ready systems under CLIA, CAP, FDA frameworks.

The ideal candidate combines deep clinical lab knowledge with experience in validation methodologies and regulatory documentation within