Clinical Laboratory QA/Compliance Specialist

MedMatch•Baton Rouge, LA

About The Position

Our client is seeking an experienced Clinical Laboratory QA/Compliance Specialist to lead and strengthen its laboratory quality management system. The role partners closely with laboratory leadership to ensure ongoing compliance with CLIA, CAP, CLSI, and applicable state and federal requirements while fostering a culture of quality and supporting the highest level of patient care. The position reports to the Laboratory Manager. The specialist maintains and improves the QMS; supports inspection, survey, proficiency testing, and audit readiness; manages laboratory documentation; monitors quality indicators; and leads investigations and corrective actions. The role also supports validation and verification activities, staff training and competency assessments, regulatory monitoring, patient safety, and operational improvement. This is a full-time, direct-hire W2 position located in Baton Rouge, Louisiana. The stated salary range is $65,000–$75,000, based on experience.

Requirements

Bachelor's degree in Medical Technology, Clinical Laboratory Science, Biology, Chemistry, or a related scientific discipline.
Current Louisiana Clinical Laboratory Personnel License, where applicable.
ASCP certification as a Medical Laboratory Scientist (MLS), Medical Technologist (MT), or equivalent certification.
3–5+ years of clinical laboratory experience, with hands-on responsibility for QA, QC, or regulatory compliance.
Working knowledge of CLIA regulations, CAP Accreditation Program requirements, CLSI guidelines, and applicable state laboratory regulations.
Experience preparing for laboratory inspections and regulatory audits.
Strong technical writing skills and experience developing SOPs, policies, validations, and regulatory documentation.
Demonstrated experience conducting root-cause analysis and implementing corrective and preventive actions (CAPA).
Excellent analytical, organizational, written, and verbal communication skills.

Nice To Haves

Experience with Orchard Laboratory Information System (LIS) or similar laboratory information systems.
Experience with quality management or document control platforms such as MediaLab.
Familiarity with IQCP development and risk-based quality planning.
Experience supporting reference laboratory or multi-site laboratory operations.
Lean, Six Sigma, or healthcare quality improvement experience.

Responsibilities

Maintain and continuously improve the laboratory Quality Management System (QMS).
Lead preparation for CAP inspections, CLIA surveys, proficiency testing programs, and internal and external audits.
Develop, review, update, and maintain laboratory SOPs, policies, and validation and verification documentation.
Monitor laboratory quality indicators, including quality control trends, turnaround times, proficiency testing performance, and quality metrics.
Lead corrective and preventive action (CAPA) investigations, root-cause analyses, and effectiveness monitoring.
Investigate quality events, nonconformances, patient complaints, and testing errors, ensuring timely documentation and resolution.
Support method validations, instrument verifications, and Individualized Quality Control Plan (IQCP) development.
Coordinate proficiency testing enrollment, submission, review, and corrective actions across laboratory departments.
Partner with laboratory leadership to support quality-related staff training, competency assessments, and ongoing education.
Maintain document control systems and keep the laboratory inspection-ready.
Monitor regulatory changes affecting laboratory operations and communicate recommendations to leadership.
Identify opportunities to improve laboratory quality, operational efficiency, patient safety, and regulatory compliance.