University of Southern California
Laboratory Services Manager - Clinical Laboratory - Full Time 8 Hour Days (Exemp
University of Southern California, Glendale, California, us, 91222
Overview
Laboratory Services Manager - Clinical Laboratory - Full Time 8 Hour Days (Exempt) (Non-Union) – Keck Medicine of USC, Hospital, Los Angeles, California. The QA, Regulatory and Compliance Manager manages the Quality Plans for the Clinical Laboratory and Pathology. Coordinates quality assessment and performance improvement activities for the Department of Pathology/USC Laboratories. Serves as Laboratory Compliance Officer and manages the Compliance Program to ensure compliance with all Federal, State and accreditation requirements for all laboratory operations and testing performed at all USC Laboratory locations. Researches, monitors, updates and communicates laboratory regulatory issues. Essential Duties
Prepares annual Laboratory Compliance Plan and Key Program Objectives. Coordinates operational aspects (agendas, meeting dates, and minutes) of the Laboratory Compliance Committee (LCC). Manages laboratory compliance variance reporting process and ensures issues are tracked and resolved in a timely manner. Administers and manages activities in the laboratory that support the University's Compliance Program. Monitors and evaluates regulatory requirements and changes affecting USC Clinical Laboratory operations. Assesses impact to processes requiring revisions or additions to applicable policies and procedures. Works with Patient Business Services to ensure a comprehensive plan to monitor and audit laboratory claims. Provides compliance training, education, and awareness activities including HIPAA Privacy and Security requirements. Assures that laboratory employees are properly trained in general compliance and, where appropriate, in areas specific to their laboratory responsibilities. Coordinates all Quality Assessment and Performance Improvement activities and communicates findings to appropriate staff and committees. Responsible for development and maintenance of QA programs for testing. Conducts in-service programs as needed and ensures collection of QA data by consulting with LIS and downloading applicable data from Cerner LIS. Acts as QA officer for Blood Bank Quality Unit as defined by AABB. Writes and reviews the annual Blood Bank Quality Plan. Responsible for writing and reviewing all policies and procedures related to QA&I, including the Annual Lab Quality Plan. Maintains current knowledge of CLIA, California, JCAHO, CAP, FDA, and Bureau of Biologics regulation and requirements. Ensures regulatory compliance of the SCML/Department of Pathology and all testing sites. Communicates with regulatory and accreditation agencies as needed to clarify current state of laws/regulations. Coordinates preparation for inspections/surveys by CAP, JCAHO, AABB, FDA, and follow-up inspection response activities. Prepares applications or other correspondence with regulatory agencies and ensures timely completion and mailing. Maintains complete, organized files of regulatory documents relating to laboratory licensure/accreditations/certifications for all testing sites. Coordinates annual purchase order of proficiency testing surveys for all sections of the laboratory, pathology and POCT at USC and other clinic testing sites. Serves as key contact with PT providers. Researches regulatory issues upon request and serves as a regulatory resource for lab management. Coordinates and maintains Laboratory General Administration Policy Manual as directed by the Administrative Director and Medical Director. Performs other duties as assigned. Required Qualifications
Bachelor's degree from an accredited university (U.S.). For degrees obtained outside the U.S., a certificate of equivalency with U.S. degree programs. Specialized/technical training: 12 CEU per year, required and approved by the State of California for continued CLS licensure. Two years of clinical laboratory supervisory/management experience. Comprehensive understanding of State and Federal laws pertaining to clinical laboratory testing and operations, and accreditation standards (JCAHO, CAP, AABB). Strong analytical problem-solving skills and excellent communication skills, including interpersonal aptitude to interact with a diverse group in a diplomatic manner. Participation in accreditation inspections (JCAHO, CAP, etc.). Understanding of quality assurance requirements of JCAHO, CAP, AABB, FDA, CLIA, and California. Understanding of clinical laboratory quality control and CQI philosophy. Familiarity with State and federal regulations governing laboratory practice, including physicians' office testing, hospital bedside testing, scope of practice, Quality Control, Quality Assurance. Understanding of OIG compliance guidance for laboratories. Proficiency with desktop tools including Internet, Outlook, Excel, PowerPoint, and Word. Ability to write and implement policies and procedures. Preferred Qualifications
Clinical Laboratory Specialist in Chemistry (ASCP) certification or ASCP certification in Chemistry or Microbiology as an MT. Required Licenses/Certifications
Clinical Laboratory Scientist (CLS) license. Fire Life Safety Training (Los Angeles City). If no card upon hire, one must be obtained within 30 days and renewed before expiration (required within LA City). The annual base salary range for this position is $145,600.00 - $240,240.00. When extending an offer of employment, the University of Southern California considers factors such as the scope and responsibilities of the position, work experience, education/training, key skills, internal peer equity, and applicable laws and contractual considerations. REQ20168051 Posted Date: 10/06/2025
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Laboratory Services Manager - Clinical Laboratory - Full Time 8 Hour Days (Exempt) (Non-Union) – Keck Medicine of USC, Hospital, Los Angeles, California. The QA, Regulatory and Compliance Manager manages the Quality Plans for the Clinical Laboratory and Pathology. Coordinates quality assessment and performance improvement activities for the Department of Pathology/USC Laboratories. Serves as Laboratory Compliance Officer and manages the Compliance Program to ensure compliance with all Federal, State and accreditation requirements for all laboratory operations and testing performed at all USC Laboratory locations. Researches, monitors, updates and communicates laboratory regulatory issues. Essential Duties
Prepares annual Laboratory Compliance Plan and Key Program Objectives. Coordinates operational aspects (agendas, meeting dates, and minutes) of the Laboratory Compliance Committee (LCC). Manages laboratory compliance variance reporting process and ensures issues are tracked and resolved in a timely manner. Administers and manages activities in the laboratory that support the University's Compliance Program. Monitors and evaluates regulatory requirements and changes affecting USC Clinical Laboratory operations. Assesses impact to processes requiring revisions or additions to applicable policies and procedures. Works with Patient Business Services to ensure a comprehensive plan to monitor and audit laboratory claims. Provides compliance training, education, and awareness activities including HIPAA Privacy and Security requirements. Assures that laboratory employees are properly trained in general compliance and, where appropriate, in areas specific to their laboratory responsibilities. Coordinates all Quality Assessment and Performance Improvement activities and communicates findings to appropriate staff and committees. Responsible for development and maintenance of QA programs for testing. Conducts in-service programs as needed and ensures collection of QA data by consulting with LIS and downloading applicable data from Cerner LIS. Acts as QA officer for Blood Bank Quality Unit as defined by AABB. Writes and reviews the annual Blood Bank Quality Plan. Responsible for writing and reviewing all policies and procedures related to QA&I, including the Annual Lab Quality Plan. Maintains current knowledge of CLIA, California, JCAHO, CAP, FDA, and Bureau of Biologics regulation and requirements. Ensures regulatory compliance of the SCML/Department of Pathology and all testing sites. Communicates with regulatory and accreditation agencies as needed to clarify current state of laws/regulations. Coordinates preparation for inspections/surveys by CAP, JCAHO, AABB, FDA, and follow-up inspection response activities. Prepares applications or other correspondence with regulatory agencies and ensures timely completion and mailing. Maintains complete, organized files of regulatory documents relating to laboratory licensure/accreditations/certifications for all testing sites. Coordinates annual purchase order of proficiency testing surveys for all sections of the laboratory, pathology and POCT at USC and other clinic testing sites. Serves as key contact with PT providers. Researches regulatory issues upon request and serves as a regulatory resource for lab management. Coordinates and maintains Laboratory General Administration Policy Manual as directed by the Administrative Director and Medical Director. Performs other duties as assigned. Required Qualifications
Bachelor's degree from an accredited university (U.S.). For degrees obtained outside the U.S., a certificate of equivalency with U.S. degree programs. Specialized/technical training: 12 CEU per year, required and approved by the State of California for continued CLS licensure. Two years of clinical laboratory supervisory/management experience. Comprehensive understanding of State and Federal laws pertaining to clinical laboratory testing and operations, and accreditation standards (JCAHO, CAP, AABB). Strong analytical problem-solving skills and excellent communication skills, including interpersonal aptitude to interact with a diverse group in a diplomatic manner. Participation in accreditation inspections (JCAHO, CAP, etc.). Understanding of quality assurance requirements of JCAHO, CAP, AABB, FDA, CLIA, and California. Understanding of clinical laboratory quality control and CQI philosophy. Familiarity with State and federal regulations governing laboratory practice, including physicians' office testing, hospital bedside testing, scope of practice, Quality Control, Quality Assurance. Understanding of OIG compliance guidance for laboratories. Proficiency with desktop tools including Internet, Outlook, Excel, PowerPoint, and Word. Ability to write and implement policies and procedures. Preferred Qualifications
Clinical Laboratory Specialist in Chemistry (ASCP) certification or ASCP certification in Chemistry or Microbiology as an MT. Required Licenses/Certifications
Clinical Laboratory Scientist (CLS) license. Fire Life Safety Training (Los Angeles City). If no card upon hire, one must be obtained within 30 days and renewed before expiration (required within LA City). The annual base salary range for this position is $145,600.00 - $240,240.00. When extending an offer of employment, the University of Southern California considers factors such as the scope and responsibilities of the position, work experience, education/training, key skills, internal peer equity, and applicable laws and contractual considerations. REQ20168051 Posted Date: 10/06/2025
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