QA Specialist – Laboratory Compliance & Audits

QUEST DIAGNOSTICS INC; Memphis (TN); On-site; USD 90,000 - 130,000; Full time

Job summary

Quest Diagnostics Inc in Memphis, TN, seeks an experienced QA professional to lead licensure, accreditation, and inspection activities across CAP, CLIA, GLS, ISO frameworks. The role coordinates internal and external QA efforts and ensures QMS compliance for all pre- through post-analytical processes.

The position focuses on proficiency testing, document control, internal audits, CAPA, and collaboration with Lab Managers and Quality Coordinators to sustain high quality standards in the local lab.

Qualifications

• Minimum of 2 years laboratory experience.
• Knowledge of CAP, CLIA, GLS, ISO standards and regulations.

Responsibilities

• Manage Proficiency Testing Programs (CAP and NYS); maintain data base and monthly summaries.
• Manage the Document Control System; support document control policies for procedures.
• Conduct Internal Audits to ensure inspection readiness and prepare reports.
• Facilitate preparation, distribution, and review of the QA Manual.
• Assist with external audits.
• Review protocols and recommend QA improvements.
• Coordinate compliance with regulations through documentation, audits and CAPA actions.
• Review quality records and investigate nonconformances with management.
• Audit training and competency programs.
• Review and approve non-conformances; ensure CAPA is implemented.
• Reportable Quality Issues and Revised Reports per SOP.
• Communicate with Lab Managers and QA staff to promote quality.
• Resource for CAP, CLIA, GLS, ISO regulatory inquiries.
• Monitor licensure and delegation per regulations.
• Ensure enrollment in external PT programs.
• Ensure APA program for tests not covered by PT.
• Compile data for QA indicators (RQI, PT outcomes, etc.).
• Review/write QA SOPs for department/lab services.
• Support compliance with company policies.
• Promote continuous quality improvement via standardization and process improvement.
• Perform special projects and other duties as assigned.

Skills

Leadership

Interpersonal skills

Communication

Detail orientation

Organization

Problem solving

Microsoft Office

Education

Bachelor’s Degree in Life Science

ASCP Certification (Preferred)

ASQ Certified Quality Auditor (Preferred)

Tools

Laboratory Information Systems

SOPs

Job description

Quest Diagnostics Inc in Memphis, TN, seeks an experienced QA professional to lead licensure, accreditation, and inspection activities across CAP, CLIA, GLS, ISO frameworks. The role coordinates internal and external QA efforts and ensures QMS compliance for all pre- through post-analytical processes.

The position focuses on proficiency testing, document control, internal audits, CAPA, and collaboration with Lab Managers and Quality Coordinators to sustain high quality standards in the local lab.