Quality Assurance Specialist
4 weeks ago
Title: Quality Specialist III
Location: Fishers, IN
Duration: 12 Months
Pay Rate: $30/hr.
Key Responsibilities:
- Implementing and maintaining patient test quality management, Pre-analytical, Analytic and Post analytic processes.
- Conducts periodic audits of the laboratory to ensure compliance of all areas with the policies of the laboratory and reports non-compliance.
- Coordinates inspections by regulatory agencies, such as CLIA/CAP.
- Responsible for maintaining licenses and registrations; facilitating applications and renewals or any other inspection-related activities.
- Coordinates the proficiency testing activities by facilitating the subscription of required proficiency testing materials, ensuring the testing are performed and results are submitted in a timely manner. Ensures that appropriate follow up on corrective action is implemented when test result/s is found unsatisfactory.
- Drafts policies, procedures and forms for laboratory Quality Management System.
- Develops and maintains document workflows for editing, review and approval.
- Monitors QA indicators and establishes criteria for monitoring service.
- Maintains up-to-date knowledge and understanding of requirements and regulations set forth by CLIA and such agencies.
Minimum Requirements:
- Bachelor's degree in a work-related discipline/field from an accredited college or university.
- Master’s degree in a work- related discipline/field preferred.
- Five (5) years of progressively responsible and directly related clinical laboratory work experience.
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