Quality Assurance Technician/Assistant

Company: Genbody America
Location: Rancho Cucamonga
Posted on: August 2, 2022

Job Description:

Job Description Salary: Hiring: Quality Assurance Technician Location: Rancho Cucamonga, CA 1) Company Introduction GenBody America is the US affiliate of GenBody, Inc., a diversified manufacturer of in vitro diagnostic test for over 70 different human diseases. With over 20 years combined experience in the diagnostic industry and through its vast network between several key institutes, universities, and hospitals, our core strength is in R&D. GenBody specializes in developing monoclonal antibodies and recombinant antigens in-house at our facility in South Korea. The GenBody COVID-19 Ag test is manufactured in California and South Korea. The US Production facility has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health. We are located in Rancho Cucamonga and Jurupa Valley. 2) What we are looking for Provides information and data reflecting the status of the product. Supervises the quality and integrity of information of our product in the QA department. Assists with corrective action and process improvement activities and assists in appropriate re-training Assists with the monthly review of the Total Quality Management Report Executes equivalency and retrospective re-validation studies/reports Reviews and release of production run in MIS system Assists with other tasks assigned by Supervisor Conducts Housekeeping audits in accordance with written procedures Assists the QA Manager in scheduled quality audits and ---as needed--- customer product inspections Assists with audits to ensure FDA/ISO/GMP compliance and to provide the basis for continuous improvement Assists in all activities relevant for FDA, customer, and regulatory audits Supervises the quality and integrity of information of our product in the QA department. 3) What qualifications are needed BS/BA in Life Science Field Preferred (Biology, Chemistry, Microbiology, Biotechnology) High School Diploma or GED Required Or 1-3 years of GMP Quality experience (i.e. food/beverage production) Should be proficient using a computer and be able to analyze data in a database/spreadsheet Will be required to stand, walk, bend, stoop, and lift 10-20lbs repeatedly and 50lbs occasionally. 0-1 years of laboratory experience 4) What we offer Competitive salary with attractive benefits package Health Insurance Paid Time Off and Paid Holidays Discretionary Bonus Perks and benefits

Keywords: Genbody America, Rancho Cucamonga , Quality Assurance Technician/Assistant, Professions , Rancho Cucamonga, California