Lab Informatics UAT Lead & Validation Specialist

Pfm; 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 seeks an Clinical Lab Information Specialist to lead UAT for LIS and related lab tech, ensure validation, and maintain regulatory documentation. You will liaise with lab ops, IT, QA, and vendors to validate and sustain compliant laboratory systems in a controlled environment.

The role emphasizes regulatory compliance (GxP, FDA 21 CFR Part 11, CLIA, CAP), system implementation, and quality documentation with a strong focus on audit readiness and continuous improvement.

Qualifications

• Bachelor’s or Master in Clinical Laboratory Science or related field.
• 5–8 years in clinical lab operations, informatics, or business analysis.
• Experience with LIS/LIMS, middleware, and instrument interfaces.
• UAT coordination and execution experience.

Responsibilities

• Lead and coordinate UAT activities for LIS, middleware, and instrument interfaces.
• Develop UAT strategies, test plans, scripts, and acceptance criteria.
• Collaborate with stakeholders to reflect real-world workflows and use cases.
• Manage defect tracking, triage, and resolution with IT and vendors.
• Ensure traceability between requirements, tests, and outcomes.
• Plan and execute system validation activities per GxP, CLIA, CAP, FDA.
• Author/Review validation deliverables and risk assessments.
• Maintain audit-ready documentation and support regulatory inspections.
• Develop and maintain SOPs, work instructions, and QMS-aligned docs.
• Gather, analyze, and translate business requirements into system specs.
• Support system implementation, upgrades, and optimization.

Skills

UAT coordination

System validation

Regulatory compliance

Business analysis

System implementation

Education

Bachelor’s or Master in Clinical Laboratory Science or related field

Tools

LIS/LIMS systems

Middleware interfaces

Job description

Precision Medicine Group seeks an Clinical Lab Information Specialist to lead UAT for LIS and related lab tech, ensure validation, and maintain regulatory documentation. You will liaise with lab ops, IT, QA, and vendors to validate and sustain compliant laboratory systems in a controlled environment.

The role emphasizes regulatory compliance (GxP, FDA 21 CFR Part 11, CLIA, CAP), system implementation, and quality documentation with a strong focus on audit readiness and continuous improvement.