Laboratory QA/QC Lead: Compliance & Validation Expert

Methodist Hospital for Surgery; Addison (TX); On-site; USD 60,000 - 85,000; Full time

Job summary

Methodist Hospital for Surgery in Addison, TX seeks a Laboratory QA & QC Coordinator to oversee the laboratory’s quality assurance, proficiency testing, and documentation programs. The role ensures compliance with CLIA, FDA, DNV, and AABB standards and requires strong experience in quality systems and laboratory operations.

Responsibilities include maintaining QA/QC records, coordinating method validation, analyzing client complaints, training staff, and preparing regulatory reports to support

Qualifications

• Minimum of 5-10 years previous lab experience required.
• Laboratory Technologist Certification required.
• Working knowledge of MS Office required.
• Thorough knowledge of lab PT, QC, and QA program requirements and CLIA & FDA regulations and DNV & AABB standards.
• Skills to initiate, expand and maintain MS Word documents.
• Skills to perform laboratory testing per services provided.
• Ability to organize information, files and reports (paper and electronic).
• Ability to work effectively with others in a collaborative environment.
• Ability to initiate, expand, and maintain MS Excel spreadsheets.

Responsibilities

• Maintains QA, QC, and proficiency testing documentation.
• Resolves test system issues and ensures remedial actions are taken.
• Prepares quality reports for QPC meetings.
• Oversees and performs method validation and calibration verification studies.
• Analyzes client complaints and risk management inquiries.
• Assists with policy review and regulatory requirements.
• Trains testing personnel and monitors competency.
• Verifies procedures and performance characteristics of tests.

Skills

Confidentiality

Collaborative work

Organization & documentation

Fast-paced environment

MS Office proficiency

Education

Laboratory Technologist Certification

Tools

MS Office

Excel

Laboratory instrumentation knowledge

Documentation management

Job description

Methodist Hospital for Surgery in Addison, TX seeks a Laboratory QA & QC Coordinator to oversee the laboratory’s quality assurance, proficiency testing, and documentation programs. The role ensures compliance with CLIA, FDA, DNV, and AABB standards and requires strong experience in quality systems and laboratory operations.

Responsibilities include maintaining QA/QC records, coordinating method validation, analyzing client complaints, training staff, and preparing regulatory reports to support