• RA Spec III

    Location US-CA-Irvine
    Requisition ID
    2018-6788
    # of Openings
    1
    Category
    RAQA
  • Overview

    What you’ll be doing:

     

    • Manage and maintain the electronic insert software program ( IGWeb). The responsibilities include functioning as the leading administrator of IGWeb, assuring  training of key users, populating  the system, request for translations, support electronic insert expansion-conduct validation testing of the system, provide user requirements for new software update, provide feedback to the Software Team on the items delivered,  understand the software validation requirements to ensure the appropriate documentation is generated for each software update and conduct validation testing of the system.
    • Prepare, coordinate and conduct the performance evaluation studies for IVD products. The study coordinator need to recruit and qualify test laboratories to conduct the studies and must have the ability to write a final evaluation report based on the study results in accordance with internal procedures.
    • Support in managing the Federal Drug Enforcement Administration’s (DEA) Controlled Substance program, including preparation and submission of ARCOs Reports, submissions of year-end inventory reports to DEA and assist in performing biennial inventory of controlled substances.
    • Implement, administrate and maintain the Medical Device Reporting, Adverse Event and Vigilance System.
    • Support product registration by preparing product components list.

    Responsibilities

    What you need for this role:

     

    • Require a Bachelor Degree in chemistry, medical technology or related field
    • Working knowledge of FDA, CE marking requirements and FDA 21 CFR part 11 requirements for electronic records is a plus
    • Professional certifications and credentials such as MLS(ASCP) and/or RAC-US are highly desired
    • Understand the software validation requirements
    • Five year or more experience in clinical laboratory testing environment or R&D/ manufacturing in the IVD industry
    • Strong critical thinking and problem solving skills
    • Excellent computer applications skills and able to perform basic statistical analysis
    • Able to work independently and with others
    • Strong customer orientation and focus
    • Effective communication skills, both written and oral
    • Strong documentation and organizational skillsStrong tact and negotiation skills

    Qualifications

    What’s in it for you:

     

    • Competitive pay and great benefits including medical, dental, vision, 401k and more
    • Opportunities for growth and training
    • Stability of a profitable 60+ year old company
    • Great work environment



    About Bio-Rad:

    Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 7,800  employees and a global network of operations serving our customers, we help people live longer, healthier lives.

    Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.

     

    EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age

     

    To all recruitment agencies: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

     

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Connect With Us!

    Not ready to apply? Connect with us for general consideration.