Onsite Lab QA Program Lead - Compliance & Audits

Quest Diagnostics Incorporated; Memphis (TN); On-site; USD 70,000 - 100,000; Full time

Job summary

Quest Diagnostics Incorporated in Memphis seeks a QA Program Specialist to drive quality assurance across pre-analytical, analytical, and post-analytical processes. The role ensures CAP, CLIA, GLS, and ISO compliance and coordinates internal and external QA activities.

The position is 5 days a week onsite with no relocation assistance. Candidates should have strong leadership and collaboration skills to support ongoing quality improvement efforts within the laboratory.

Qualifications

• Requires minimum 2 years of laboratory experience.
• Knowledge of CAP, CLIA, GLP, ISO standards and regulations.
• Bachelor's degree in Life Science or equivalent field is required.

Responsibilities

• Manage Proficiency Testing Program (CAP and NYS); maintain database and monthly summaries.
• Manage Document Control System and ensure compliance with procedures.
• Conduct Internal Audits and prepare inspection readiness reports.
• Facilitate preparation, distribution, and review of QA Manual; assist with external audits.
• Review protocols and recommend QA program enhancements.
• Coordinate compliance through documentation, audits, and CAPA actions.
• Review quality records and investigate nonconformances with management.
• Audit training and competency programs; ensure corrective actions are sustained.
• Reportable Quality Issues and Revised Reports reporting per SOP.

Skills

Leadership

Communication skills

Detail-oriented

Project coordination

Teamwork

Problem-solving

MS Office proficiency

Laboratory operations knowledge

Education

Bachelor's Degree in Life Science

Tools

Laboratory Information Systems

Microsoft Office

Job description

Quest Diagnostics Incorporated in Memphis seeks a QA Program Specialist to drive quality assurance across pre-analytical, analytical, and post-analytical processes. The role ensures CAP, CLIA, GLS, and ISO compliance and coordinates internal and external QA activities.

The position is 5 days a week onsite with no relocation assistance. Candidates should have strong leadership and collaboration skills to support ongoing quality improvement efforts within the laboratory.