Laboratory Quality Assurance Manager
This position leads Quality Assurance programs in a CLIA laboratory and supervises the Quality team. Performs a broad range of administrative, analytical, and executive duties related to assessing, planning, implementing, and monitoring laboratory quality, regulatory compliance, and performance improvement. In collaboration with lab leadership, this position is responsible to identify, plan, and execute strategies and methods to monitor and promote laboratory quality and regulatory compliance.
Primary Duties & Responsibilities
• Responsible for maintaining and assessing the Laboratory's quality assurance (QA), quality improvement (QI) indicators, safety programs and education and laboratory testing.
• Responsible for assessing patient test management in the pre-analytic, analytic and post-analytic processes, review and compilation of complaints and incident reports, and
• Develops action plans and metrics needed to monitor progress toward meeting quality improvement objectives.
• Monitors standards enacted by regulatory and accrediting agencies.
• Works with the Laboratory Director, Lab Management, Chief Laboratory Officer, Operations Manager, Lab supervisors and other staff in coordinating QA activities of the labs.
• Maintains up-to-date knowledge and understanding of requirements and regulations set forth by CLIA and other regulatory agencies, FDA, Occupational Safety and Health Administration and Center for Disease Control.
• Maintains inspection readiness and assist with internal and external audits by regulatory and accrediting agencies.
• Responsible for facilitating any required documentations for new or renewal of laboratory licenses and certificates for CDPH, CMS, etc.
• Coordinates the proficiency testing activities, 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.
• In collaboration with Laboratory Directors, Chief Laboratory Officer, Operations Manager, chooses ongoing QA indicators and criteria for monitoring service.
• Generates reports to track performance and quality improvement.
• Collects and collates data and implements changes to resolve problems.
• Provides support for the creation of QA reports for regulatory agencies.
• Prepares and conducts quarterly QA and Safety meeting
• Maintains familiarity with local, state and federal regulations regarding the handling and storage and disposal of chemicals and biohazardous material with the laboratory.
• Serves as a source of reference for regulations pertaining to laboratory safety, chemical hygiene and safe disposal of chemical and biohazardous materials.
• Creates safety training programs that promotes safe practices within the laboratory and employee knowledge of the hazards and possible exposures inherent to the work in the clinical and anatomic pathology laboratory.
• Monitors laboratory staff regarding issues related to health and safety and notifies supervisory staff of any problems to ensure compliance with safety policies and procedures.
• Responsible for the planning, development and standardization of the Safety Manuals, Chemical Hygiene Plan, Exposure Control Plan and Infection Control Plan consistent with legal requirements and company policies and procedures.
• Maintain document control system for the creation, review, and revision of laboratory administrative and safety policies and procedures.
• Reviews revisions of policies and procedures for compliance with regulatory standards and enhancement of process quality.
• Oversees and coordinates laboratory training programs.
Education and Experience
• Bachelor's degree in a science in a related discipline/field.
• Five (5) years of progressively responsible and directly-related Quality Assurance work experience in a CLIA laboratory environment.
• License/Certification: Clinical Lab Scientist (CLS) preferred