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QM/Clinical Research Assistant

2 months ago

Rancho Cucamonga, United States Kwell Laboratories LLC Full time
Job DescriptionJob DescriptionSalary:

Job Position: QM/Clinical Research Assistant

Location: Rancho Cucamonga, CA


Company Introduction

Kwell Laboratories is the US affiliate of GenBody, Inc., a diversified manufacturer of in vitro diagnostic test for over 70 different human diseases. GenBody’s core strength is in R&D with over 20 years combined experience in the diagnostic industry and through its vast network between several key institutes, universities, and hospitals. GenBody specializes in developing monoclonal antibodies and recombinant antigens in-house at its facility in South Korea.


Kwell Laboratories has an established US manufacturing plant of rapid in-vitro diagnostic kits as a recipient of federal funds through the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative. We are looking to expand our product catalogue in the upcoming years and provide the best rapid diagnostic instruments.


Responsibilities

  • Assist QM Manager in QMS management & Clinical Study duties
  • Assist in the research of upcoming product’s FDA regulations & pre-submission stages
  • Assist in handling customer complaints
  • Travel to manage clinical study sites, up to one month

 

Qualifications

  • 0-1 year experience in Junior QA or Clinical Research Assistant
  • Proficiency in English and Korean preferred -- both orally and written
  • Proficiency with Microsoft Office
  • Interest in the in-vitro diagnostics field
  • Willingness to learn and provide assistance in clinical studies and QMS

 

Offer

  • Competitive salary
  • Health Insurance
  • Paid Time Off and Paid Holidays
  • Discretionary Bonus
  • Perks and benefits