Clinical Laboratory Quality Analyst
- Wichita, KS
- Permanent
- Full-time
- Provide data for quality teams and support all Quality Improvement efforts
- Schedule and conduct regular QA audits and inspections of assigned departments and facilities and perform audit reports
- Ensure complete and accurate readiness for all inspections and maintain all necessary documents
- Participate in regulatory and accrediting agency inspections when needed
- Draft responses to regulatory complaints and inspection
- Stay current with all regulatory agency and proficiency test requirements
- Participate in monthly Quality meetings and compose minutes
- Serve as a resource on regulatory issues and compliance
- Perform administrative and clerical duties as needed
- Provides guidance and support to assigned staff performing point of care. Creates and/or assists with training, and ensures appropriate stock of reagents, quality control materials, etc.
- Monitors competencies and is available for follow up when lock out occurs.
- Monitors middleware for inappropriate barcode scanning, testing and resulting errors, and reports as appropriate.
- Oversees and audits analyzer/cartridge failures and arranges for service or replacements.
- Develops new POC test setups which may include project management, vendor and Laboratory Information Services representation, and validation of new tests. Authors policies.
- Provides administrative, technical and educational guidance for all testing performed. Ensures compliance with all regulatory agencies and accreditation standards with regards to safety and POC testing for all system laboratory sites.
- Provides guidance and leadership to others responsible for POC functions across the system or multiple departments.
- Reviews, analyzes and reports on POC testing quality control and compliance data. Compiles monthly and annual compliance and incidence report summaries.
- Acts a resource for the evaluation, implementation and monitoring of all new POC testing.
- Bachelor’s degree in a Chemical or Biological science, Clinical Laboratory Science, or Medical Technology
- 2 years experience as a Medical Technologist in core lab setting required
- Prior experience in a quality related position preferred
- Familiarity with an electronic data management system is a plus (i.e. MasterControl)
- General knowledge of laboratory regulations (TJC/CLIA/FDA/FACT) and licensing requirements
- ASCP certification is preferred
- Strong understanding of audit related requirements and procedures
- Working knowledge of quality assurance/quality management best practices
- Excellent analytical, critical thinking and problem solving skills
- Strong communication skills; both written and verbal
- High level of attention to detail with strong organizational skills
- Ability to work independently and within a team environment
- Strong computer skills with proficiency with MS Office programs