*ETHOS LABORATORIES* – Newport, KY
LOCATION: This position is located in Newport, KY, two blocks from Newport on the Levee.
HOURS: Monday – Friday, 8:00AM – 4:00PM
The Quality Coordinator supports and coordinates efforts that foster quality and ensure that all pre-analytical, analytical, and post-analytical processes are consistent with applicable state regulations, College of American Pathologist (CAP) standards, and the values and mission of Ethos Laboratories. This person is also responsible for collaborating with each department on quality initiatives, as well as document control, licensing, and accreditation activities.
EDUCATION AND EXPERIENCE REQUIREMENTS:
- Bachelor’s degree required (chemistry, physics, biology, clinical laboratory science, or medical technology)
- Minimum of three years of experience in a laboratory setting required
- Preferred experience:
- Quality Assurance
- Statistical quality control
- Clinical laboratory regulations
- CAP accreditation standards
- MediaLab software
- Coordinates and maintains all quality assurance program activities.
- Maintains systems and controls to ensure consistency and compliance with applicable regulatory requirements.
- Collaborates with each department on the creation and monitoring of quality indicators for focused process, quality, or performance improvement.
- Plans for improved quality through the use of continuous quality improvement plans (cQIPs), blind audits, and focus studies as needed.
- Works with Technical Supervisor and/or Laboratory Director to ensure enrollment and participation in proficiency testing (PT) for each analyte, including review/submission of PT results, record keeping, identifying trends, reporting on PT performance in meetings, and maintaining spreadsheets.
- Maintains and updates (as needed) the Quality Management System (QMS).
- Reviews, categorizes, interprets, and identifies trends with internal incident reports.
- Compiles and completes quarterly quality assessments and annual review of effectiveness.
- Holds quarterly Quality Committee meetings to discuss quality initiatives and performance.
- Participates in overall safety compliance initiatives and safety metrics per regulatory requirements; attends monthly Safety Committee meetings.
- Assumes other duties as assigned by the Laboratory Director.
- Supports the internal/external inspection process of the laboratory and associated sites to ensure compliance with applicable federal, state, and local regulations, College of American Pathologists (CAP) accreditation requirements, and Ethos standards.
- Serves as a resource regarding Clinical Laboratory Improvement Amendments (CLIA) regulations and CAP accreditation standards.
- Interprets regulations and standards for application in the laboratory and associated sites.
- Collaborates with department supervisors/managers in ensuring thorough understanding of and compliance with applicable regulations and standards.
- Coordinates pre-inspection meetings with CAP Team Leads as needed.
- Maintains current state and organizational licensing; coordinates submission of renewal documents as needed.
- Site Administrator for MediaLab software, including Document Control, Compass, InspectionProof, and IQE.
- Maintains all controlled documents within MediaLab, assigning new document numbers and creating new manuals as needed.
- Ensures appropriate workflows for document review/approval process within MediaLab.
- Creates and supports the creation of continuing education materials within MediaLab.
- Maintains InspectionProof within MediaLab to ensure the laboratory is inspection-ready at all times. Provides end-user training and/or troubleshooting as needed.
- Understanding of clinical laboratory operations.
- Knowledge of laboratory regulatory requirements, specifically CAP and CLIA. Past participation in internal or external laboratory inspection teams preferred.
- Analytical/critical thinking; able to analyze, interpret, and identify trends.
- Demonstrated success in collaborating and motivating team members to reach objectives.
- Ability to effect quality improvement through problem solving skills and knowledge of quality tools.
- Attitude focused on bringing solutions.
- Proficient with Microsoft Office Applications.
- Regular and prompt attendance.
- Effective verbal and written communication skills.
- Change management, project management, and planning skills.
- Organized and able to prioritize and multi-task effectively.
- Ability to work independently and cohesively as part of a team.