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Quality Manager

2 months ago

San Diego, United States US Specialty Labs Full time
Job DescriptionJob DescriptionOPEN TO PART TIME OR FULL TIME


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