• Quality Systems Specialist II

    Location US-CA-Richmond
    Requisition ID
    2018-7460
    # of Openings
    1
    Category
    Quality & Regulatory
  • Overview

    Bio-Rad is looking for a Quality Systems Specialist II.

    Responsibilities

    • Under the direction of the QA Manager or senior QA personnel the candidate will perform a variety of quality assurance and administrative duties to include the following:
    • Identify, sort and classify hard-copy customer agreements related to quality, change notification and audits.
    • Assist in the development of an organized filing and tracking system for customer-facing QA records, this may also involve assisting with revision and clean-up of an existing Access Database
    • Respond to and/or coordinate customer requests initiated in SFDC QMS survey requests.
    • Document current state processes where needed.
    • Evaluate change requests for significance and notification requirements.
    • Help prepare and ensure distribution of customer notifications according to established customer agreements.
    • Negotiate and finalize Customer Quality Agreements and Change Notifications.
    • Create and maintain metrics/dash boards relative to customer requests.
    • Back up / support other Quality Systems Specialists in the areas of batch record review, product release, internal audits, Customer Audits, and data analysis and Quality Notification (QN) task management.

    Qualifications

    • Associates degree or equivalent in Biology, Chemistry, or related field.
    • 2+ years’ experience in a regulated manufacturing industry or equivalent combination of education and experience.
    • Some experience within the Biotech/Pharmaceutical GMP industry preferred.
    • Good time management skills, detail-oriented, well organized and able to multi-task.
    • Excellent communication skills.
    • Exposure to ISO 13485 Quality Management Systems.
    • Proficient in Microsoft Office (Excel especially), Livelink, Visio.
    • Familiarity with Access database would be an asset.

     

    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

     

    Agency Non-Solicitation:

     

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

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