Lab Informatics UAT & Validation Lead

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

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement savings plan

Life insurance

Disability coverage

Parental leave

Paid time off

Job summary

Precision Medicine Group in Frederick, MD is seeking a Clinical Lab Information Specialist who leads UAT for LIS/LIMS, manages validation activities, and drafts regulatory documentation to ensure compliant laboratory systems.

The role collaborates with Laboratory operations, IT, Quality and vendors; requires 5–8 years in clinical lab informatics, experience with GxP and FDA 21 CFR Part 11, and hands-on validation; onsite work with competitive benefits and bonus eligibility.

Qualifications

• Bachelor’s or Master in Clinical Laboratory Science, Life Sciences, Health Informatics, or related field.
• 5–8 years in clinical lab ops, informatics, or business analysis.
• Experience with LIS/LIMS, middleware, and instrument interfaces.
• Proven UAT coordination and execution experience.
• Experience with validation in regulated environments (GxP, CLIA, CAP, FDA).
• Experience authoring validation and regulatory documentation.

Responsibilities

• Lead and coordinate UAT activities for LIS, middleware, interfaces.
• Develop UAT strategies, test plans, scripts, and acceptance criteria.
• Partner with laboratory stakeholders to reflect real-world workflows in tests.
• Plan and execute system validation activities per regulatory standards.
• Author and review validation deliverables (VP, URS/FRS, IQ/OQ/PQ, risk assessments).
• Develop and maintain SOPs and quality documentation related to lab systems.

Skills

UAT coordination

Laboratory informatics

Regulatory documentation

System implementation

Education

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

Tools

Epic Beaker

SCC Soft

Sunquest

Cerner Millennium

Job description

Precision Medicine Group in Frederick, MD is seeking a Clinical Lab Information Specialist who leads UAT for LIS/LIMS, manages validation activities, and drafts regulatory documentation to ensure compliant laboratory systems.

The role collaborates with Laboratory operations, IT, Quality and vendors; requires 5–8 years in clinical lab informatics, experience with GxP and FDA 21 CFR Part 11, and hands-on validation; onsite work with competitive benefits and bonus eligibility.