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Quality Manager
2 months ago
POSITION SUMMARY
The Quality Assurance Manager is responsible for monitoring the pre-analytical, analytical and post analytical process of the clinical laboratory services and ensuring compliance with regulatory, state and accreditation requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Oversees, plans, coordinates, and manages quality assessment programs designed to ensure compliance with established standards of laboratory practice, CLIA, State regulations, CAP, and other laboratory accrediting agencies.
- Works with the Medical Director to oversee, plan, coordinate, and manage quality assessment programs.
- Includes the responsibility of directing all quality activities of all pre-examination, examination and post-examination phases in the laboratory.
- Performs training and competency assessments for the laboratory staff including Clinical Lab Scientists.
- Responsible for managing all phases of Proficiency Testing activities at USSL.
- Implement and oversee CAPA (Corrective and Preventative Actions), validations, inspections, document control, regulatory affairs, and problem resolution.
- Producing and/or overseeing the creation of documentation as it applies to quality assurance and regulatory affairs and manage document retention and control.
- Implements and maintains the web-based Document Control System at USSL.
- Act as the primary interface with external Quality Auditors and Regulatory Agencies during on-site audits, license and permit renewals, and follow-ups
- Coordinate and provide relevant documentation to Regulatory Agencies to enable timely product/ service registrations
- Responsible for the application and re-validation of Medicare licenses.
- Implementation of meaningful QA metrics for pre-analytical, analytical and post-analytical phases of laboratory testing.
- Responsible for presenting quarterly QMS metrics to management and staff.
- Responsible for ensuring adherence to environmental and safety protocols in compliance with State and Federal regulations.
QUALIFICATIONS
A minimum of 6 years of experience in quality positions.
EDUCATION and/or EXPERIENCE
Bachelor Degree in Science required. MBA a plus. CA State License required. CLS required