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Lab Quality Assurance Analyst I

2 months ago

Clarksville, United States HealthTrackRX Full time
Job DescriptionJob Description

Who is HealthTrackRx?

HealthTrackRx is the nation's leading PCR-based infectious disease laboratory By delivering next morning results to healthcare providers nationwide, HealthTrackRx is the premier option for patients and healthcare professionals and in an exciting phase of growth

Job Summary:

The QA Analyst is a supportive role within the QA department that assists with planning, implementing, and monitoring the Quality Management System (QMS). The QA Analyst is responsible for ensuring that the laboratory meets quality and productivity standards and complies with all regulatory and safety standards as defined by CAP, JCAHO, CLIA and OSHA.

Essential Responsibilities/Duties:

  • Ensures regulatory preparedness at all times by maintaining procedure manuals, training records, validation documents, personnel records, quality documentation, etc. while adhering to CAP, CLIA, and OSHA standards.
  • Maintain procedural manuals in applicable areas of the laboratory.
  • Participates in laboratory audits and accreditation inspections, at the capacity requested by QA management.
  • Acts as a liaison between all departments in the laboratory (including Pre-Analytic, Analytic, and Post-Analytic) and the QA department to answer quality-related questions, implement policies/procedures, and enforce quality objectives.
  • Ensures the Document Control System maintains the integrity and organizational standards set by QA management.
  • Ensures that all equipment, machines, or instruments are maintained, inspected, and calibrated.
  • Keeps records of applicable service and maintenance agreements as well as logs, as applicable.
  • Executes verification of laboratory documentation (e.g., temperature/humidity monitoring, various logs, etc.) on a routine basis established by the QA department.
  • Maintains knowledge of proper specimen collection procedures, including patient preparation, labeling, handling, preservation, processing, preparation, transportation, and storage of specimens.
  • Obtains QA documentation and data to assist in the creation of monthly/annual Quality Reports, as well as establish effective systems to monitor accuracy assessments and data quality throughout the laboratory.
  • Conducts QA procedures to monitor core performance and notifies QA management and area supervisor of performance issues as the issues develop and works with the area supervisor to establish a remediation plan.
  • Maintains licensures as applicable and participates in continuing education; ensure staffing does the same.
  • Acts as a member of the Safety and QA/PI Committee, attend meetings and implement changes, as needed:
  1. Participates as a member of other committees, as assigned.
  2. Pulls monthly QA data and follows through on issues report in a timely manner.
  3. Reviews and maintains records of maintenance.
  4. Participates with the QA department in overseeing all clinical laboratory departments in a manner conducive to optimal performance and high morale.
  5. Follows the laboratory’s procedures for specimen handling and processing, test analyses, reporting, and maintaining records of patient test results.
  6. Maintains records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens.

Collaborative Duties:

  • Inspection/Audits/Surveys:
  1. Coordinates pre-inspection evaluations, post-inspection responses, and interim self-inspections with laboratory management and staff. The expectation is the laboratory be prepared and operates on a day-to-day basis to result in no deficiencies on any scheduled, random, or unannounced inspection from any accrediting agency including but not limited to CLIA, CAP, OSHA, Department of Health, State, etc.

  • Quality/Safety Program:
  1. Acts as or works with the QA and Safety Supervisor; attends Committee meetings to implement changes as needed.
  2. Leads and/or assists in the development/ongoing continuous quality management for the laboratory.
  3. Reviews monthly metrics and assists in corrective action/procedural changes to maintain “green light” status per desired/required goal.
  4. Participates in the local and national quality/safety committee meetings, as requested.
  5. Assists in preparing the annual laboratory quality assessment plan that is evaluated for its effectiveness and assembles new initiatives planned by Laboratory Director, Partner Laboratory Quality and Compliance Director, Laboratory Management, and Quality Committee members.
  6. Works with IT to develop programs to automatically collect and collate data for the committee.

  • Process Improvement/Implementation:
  1. Evaluates and assists with lean projects in the laboratory that works to improve overall processes to help the company provide quality care in a cost effective and timely manner to its patients.

Qualifications:

Education:

  • Bachelor’s degree, required

Competencies/Skills:

  • Ability to create and present presentations to small and large groups
  • Basic math skills: Ability to create and work with statistical data
  • Ability to perform, create, and interpret statistical data for validations, correlations, etc.
  • Ability to quickly learn proprietary software programs (e.g. LIS, Media Lab, Asana, etc.).

Experience:

  • 2 years prior clinical laboratory experience, preferred