Pathology Lab QA Lead Compliance & Audits

University of Maryland Medical System; Baltimore (MD); On-site; USD 70,000 - 100,000; Full time

Job summary

University of Maryland Medical System seeks a Quality Assurance professional to oversee the Laboratories of Pathology QA program. The role ensures compliance with FDA, AABB, CLIA, CAP, TJC and related standards, developing and validating procedures and leading inspections.

You will manage training, auditing, and documentation, coordinating with risk management and other departments to sustain high-quality laboratory operations for patient care.

Qualifications

• Bachelor degree required in a relevant discipline.
• Four years of progressively responsible experience in a lab.
• Two years of QA experience; knowledge of AABB, FDA, FAHCT, TJC, CLIA, CAP, transfusion services preferred.

Responsibilities

• Oversee and coordinate quality assurance activities for Laboratories of Pathology.
• Manage quality assurance program to ensure regulatory compliance.
• Write, review, edit, and validate standard operating procedures.
• Represent the Labs of Pathology during inspections by FDA, AABB, CAP, TJC, FAHCT.
• Develop training, education, equipment, and safety programs with Laboratory leadership.
• Conduct internal audits and document trends; follow up on corrective actions.

Skills

Quality Assurance

Regulatory Compliance

Technical Writing

Laboratory Knowledge

Education

Baccalaureate degree

Medical Technologist certification preferred

Job description

University of Maryland Medical System seeks a Quality Assurance professional to oversee the Laboratories of Pathology QA program. The role ensures compliance with FDA, AABB, CLIA, CAP, TJC and related standards, developing and validating procedures and leading inspections.

You will manage training, auditing, and documentation, coordinating with risk management and other departments to sustain high-quality laboratory operations for patient care.