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Quality Assurance Specialist

2 months ago

Clarksville, Indiana, United States HealthTrackRx Full time
Job Summary

The Quality Assurance Analyst plays a vital role in ensuring the laboratory meets quality and productivity standards, adhering to regulatory and safety standards as defined by CAP, JCAHO, CLIA, and OSHA.

Key Responsibilities
  • Maintain regulatory preparedness by ensuring procedure manuals, training records, validation documents, personnel records, and quality documentation are up-to-date and compliant with CAP, CLIA, and OSHA standards.
  • Participate in laboratory audits and accreditation inspections, providing support to QA management as needed.
  • Act as a liaison between laboratory departments and the QA department, addressing quality-related questions, implementing policies and procedures, and enforcing quality objectives.
  • Ensure the Document Control System maintains the integrity and organizational standards set by QA management.
  • Verify laboratory documentation, including temperature and humidity monitoring, logs, and specimen collection procedures.
  • Conduct quality procedures to monitor core performance, notifying QA management and area supervisors of performance issues and collaborating on remediation plans.
  • Maintain licensures and participate in continuing education, ensuring staffing does the same.
Collaborative Duties
  • Coordinate pre-inspection evaluations, post-inspection responses, and interim self-inspections with laboratory management and staff.
  • Participate in the Quality/Safety Program, attending committee meetings to implement changes as needed.
  • Lead and/or assist in the development of ongoing continuous quality management for the laboratory.
  • Review monthly metrics and assist in corrective action/procedural changes to maintain 'green light' status.
Requirements
  • Bachelor's degree, preferred.
  • 2 years prior clinical laboratory experience, preferred.
  • Ability to create and present presentations to small and large groups.
  • Basic math skills: Ability to create and work with statistical data.
  • Ability to quickly learn proprietary software programs.