Clinical Laboratory QA/Compliance Specialist
Summary
A Clinical Laboratory QA/Compliance Specialist at Orion Laboratories, a CLIA-certified, CAP-accredited clinical reference lab in Baton Rouge, LA. Day to day: maintaining the quality management system, prepping for CAP/CLIA inspections and audits, writing SOPs, running CAPA/root-cause investigations, and coordinating proficiency testing. Onsite, Mon–Fri, Central hours.
Clinical Laboratory QA/Compliance Specialist
Orion Laboratories | Baton Rouge, LA
Full-time | Monday-Friday, 8:30 AM-5:30 PM Central
Company Overview
Orion Laboratories is a CLIA-certified, CAP-accredited clinical reference laboratory headquartered in Baton Rouge, Louisiana. As the largest independent laboratory in the region, we provide clinical and diagnostic testing services to physicians, hospitals, employers, and government agencies across the Gulf South. Through our new partnership with FMOL Health, we're growing fast, and our quality program has to grow with us.
We are seeking an experienced Clinical Laboratory QA/Compliance Specialist to lead and strengthen our laboratory quality management system. This position is ideal for a laboratory professional with extensive knowledge of laboratory quality assurance, regulatory compliance, and accreditation standards who is passionate about continuous improvement and ensuring the highest level of patient care.
Reporting to the Laboratory Manager, this role partners closely with laboratory leadership to ensure ongoing compliance with CLIA, CAP, CLSI, state, and federal regulatory requirements while fostering a culture of quality throughout the organization.
What You Will Own
- Maintain and continuously improve Orion Laboratories' 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 Standard Operating Procedures (SOPs), policies, 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 while 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 all laboratory departments.
- Partner with laboratory leadership to support quality-related staff training, competency assessments, and ongoing education.
- Maintain document control systems and ensure the laboratory remains inspection-ready at all times.
- Monitor regulatory changes affecting laboratory operations and communicate recommendations to leadership.
- Identify opportunities to improve laboratory quality, operational efficiency, patient safety, and regulatory compliance.
What You Bring
- 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 with 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.
Preferred
- 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.
Base salary: $65,000-$75,000, based on experience. Benefits include medical, dental, life insurance, paid time off (PTO), a 401(k) with a 5% employer match, and other standard Orion Laboratories employee benefits.