Joanna (JB) Hipolito, MHA, CLS - Clinical Laboratory Scientist

Manager of Regulatory Affairs at HORIBA Medical
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Contact Information
us****@****om
(386) 825-5501
Location
Irvine, California, United States, US
Languages
  • English -
  • Tagalog -

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Credentials

  • Clinical Laboratory Scientist
    Dept. of Public Health

Experience

    • Research Services
    • 700 & Above Employee
    • Manager of Regulatory Affairs
      • Jan 2021 - Present

      Responsible for leading the activities for the development, coordination, and execution of the clinical trial activities and the US clinical site studies in support of 510k submission(s), as well as the evaluation of the safety and effectiveness of new products, processes and methods, interface with the FDA and achievement of the departmental and corporate goals. Responsible for leading the activities for the development, coordination, and execution of the clinical trial activities and the US clinical site studies in support of 510k submission(s), as well as the evaluation of the safety and effectiveness of new products, processes and methods, interface with the FDA and achievement of the departmental and corporate goals.

    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Point of Care Coordinator
      • Mar 2018 - Dec 2020

      Responsible for the management, coordination and oversight of a system-wide Point of Care Testing Program including both nursing and laboratory duties needed to support Point of Care Testing.

    • Core Lab Supervisor
      • Feb 2016 - Mar 2018

      Supervises personnel and oversees the daily operation and provides technical expertise in the Core Lab. Ensures compliance with all regulatory standards in these sections and maintains on-going quality assurance and performance improvement.

    • Point of Care Coordinator
      • Nov 2014 - Jan 2016

      Responsible for the management, coordination and oversight of a system-wide Point of Care Testing Program including both nursing and laboratory duties needed to support Point of Care Testing.

    • Hospitals and Health Care
    • 700 & Above Employee
    • Clinical Laboratory Scientist II
      • Aug 2012 - Oct 2014

      Rotates in the Automation Department: Hematology, Chemistry, Urinalysis & Coagulation, Serology, CSF and Body Fluids. Assist Leads/Supervisor with special projects and training of new staff. Served as the LABORATORY AMBASSADOR – currently working with Medical Director, Administrative Director, and Nursing Directors to build a better relationship between the Clinical Laboratory and other Health Care Professionals. Rotates in the Automation Department: Hematology, Chemistry, Urinalysis & Coagulation, Serology, CSF and Body Fluids. Assist Leads/Supervisor with special projects and training of new staff. Served as the LABORATORY AMBASSADOR – currently working with Medical Director, Administrative Director, and Nursing Directors to build a better relationship between the Clinical Laboratory and other Health Care Professionals.

    • Clinical Laboratory Scientist II
      • May 2010 - Jul 2012

      Worked as a GENERALIST in a highly demanding county hospital. Worked as a GENERALIST in a highly demanding county hospital.

    • United States
    • Higher Education
    • 700 & Above Employee
    • Clinical Laboratory Scientist/Microbiologist
      • Jan 2008 - Apr 2010

      Department of Microbiology – MICROBIOLOGIST: Bacteriology, Parasitology (including Malaria prep and identification), and Serology. Performs routine isolation, interpretation, identification, susceptibility for any specimens for microbiology. Also performs testing in serology using rapid testing. Trained in Parasitology and reads Malaria stains. Uses laboratory machines and the computer for input of results. Routinely teaches rotating Medical Lab Residents. Department of Microbiology – MICROBIOLOGIST: Bacteriology, Parasitology (including Malaria prep and identification), and Serology. Performs routine isolation, interpretation, identification, susceptibility for any specimens for microbiology. Also performs testing in serology using rapid testing. Trained in Parasitology and reads Malaria stains. Uses laboratory machines and the computer for input of results. Routinely teaches rotating Medical Lab Residents.

    • Medical Technologist Intern
      • Mar 2006 - Apr 2007

      Rotated in various aspects of the clinical laboratory as well as did phlebotomy duties. Also includes the Pathology Department. Rotated in various aspects of the clinical laboratory as well as did phlebotomy duties. Also includes the Pathology Department.

Education

  • University of Phoenix
    Master's in Health Administration, Health/Health Care Administration/Management
    2010 - 2012
  • Far Eastern University - Dr. Nicanor Reyes Medical Foundation
    Bachelor's in Medical Technology, Clinical Laboratory Science/Medical Technology/Technologist
    2003 - 2007
  • West High School - Torrance, CA
    High School
    1999 - 2001
  • Far Eastern University
    Bachelor of Applied Science - BASc, Clinical Laboratory Science/Medical Technology/Technologist
  • Far Eastern University
    Clinical Laboratory Science/Medical Technology/Technologist

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