QA Validation Engineer
Exactech
Technical Consultant, CLIA
Lighthouse Lab Services
part-time
Posted on:
Origin: • 🇺🇸 United States • North Carolina
Visit company websiteSalary
💰 $30 - $34 per hour
Job Level
JuniorMid-Level
About the role
- Manage technical and quality operations for up to twenty moderate-complexity client laboratories nationwide.
- Contribute to consulting efforts, identify systemic issues, design efficient workflows, and implement process improvements to support accessible quality laboratory testing.
- Serve as Technical Consultant and fulfill responsibilities provided by 42 C.F.R. § 493.1413, and applicable state, local, and accrediting organization requirements.
- Prepare client laboratories for surveys and inspections by regulatory or accrediting bodies.
- Prepare and/or update Client Standard Operating Procedures (SOPs).
- Execute proactive, independent, strategic project management, planning, and organization.
- Accept and complete quality assurance (QA) / quality control (QC) projects and task management.
- Complete documentation and record-keeping requirements and assignments.
- Promptly respond to communications from clients and help resolve issues and questions.
- Support a team-oriented approach with high-level communication; occasional travel to make in-person visits to client laboratories as assigned.
Requirements
- Associate’s degree in medical laboratory technology, medical laboratory science, or clinical laboratory science; and 4 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of Chemistry (routine, endocrinology) and adherence to clinical laboratory regulations.
- OR Bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; and 2 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of Chemistry (routine, endocrinology) and adherence to clinical laboratory regulations.
- Experience in preparation and lead of laboratory accreditation (i.e. CLIA, COLA, CAP, and/or TJC) and licensing surveys/inspections.
- Minimum of 1 year of project management or account management experience, or equivalent experience.
- Must be available weekdays within the 9 AM - 5 PM EST window.
- Candidates near Charlotte, NC or Dallas, TX are strongly preferred (some in-person work at headquarters may be required).
- Ability to travel occasionally for in-person client laboratory visits.
