• Associate, Human Tissue Quality Assurance (HTQA)

    Posted Date 3 weeks ago(6/29/2018 12:38 PM)
    Job ID
    2018-2008
    Job Location
    US-GA-Kennesaw
    # of Openings
    1
    Category
    Quality Assurance
  • Introduction

    Is This The Role For You?

     

    We hire smart people with big hearts.  People who have a passion for their work and who strive every day to help others. Our work requires bold and innovative leaders; people who bring strong values and ethics to their role.

     

    If you’re ready for a career that allows you to grow and develop into the professional you want to be – today and in the future….CryoLife is the place for you.

    Position Overview

    Review all records associated with the processing of human tissues/products to ensure human tissue/products meet all required quality specifications and regulatory standards prior to release for distribution. Will ensure that all areas outlined under “Principal Responsibilities” are accomplished in an efficient, professional manner.

    Responsibilities

    Essential functions include, but are not limited to:

     

    • Perform quality control functions, such as autoclave inspections, sample submissions, label verifications, dry shipper inspection and testing, etc.
    • Perform quality assurance review of batch and material records, equipment and environmental monitoring records, cleaning records, cryopreservation and tissue transfer records.
    • Perform quality assurance review of tissue processing records, including repackaging records, for all tissue types.
    • Perform quality assurance review of distribution records.
    • Perform quality assurance review and disposition of returned tissue/product.
    • Perform quality reject disposition and assessment for enrollment into various tissue requests.
    • Interface with Tissue Processing Laboratory, Donor Quality Assurance, Shipping, and other applicable personnel to clarify and/or correct the information provided, and to solicit required information.
    • Understand ISO requirements, GTPs, and the Quality System Regulations as they pertain to the entire operation, i.e., nonconformities, Good Documentation Practices, calibration, equipment maintenance, tissue/product storage and identification, etc.
    • Develop systematic methods for completing work assignments to ensure deadlines are met and personal job commitments are accomplished.
    • Keep self, superiors, and associates informed of significant information, company policies and procedures, and will provide such information in a manner that others give support and willing cooperation.
    • Perform final quality review and generation of allograft Certificate of Assurance.
    • Will have the ability and interest in being on the job every day as required by current attendance policies.
    • Will effectively complete “other” functions that may be assigned.

    Qualifications

    • Bachelor’s Degree, preferably in the Life Sciences or an equivalent field of study.
    • Strong communication skills, strong mathematical skills, and the ability to communicate and interface with people at all levels.
    • Personal computer skills, i.e. word processing, spreadsheets, and general data analysis.
    • Ability to lift up to 60 pounds.

    Company Info

    Who We Are.

     

    CryoLife is one of the world’s contemporary medical device companies providing preserved human cardiac and vascular tissues, surgical adhesives and sealants, cardiac lasers and implantable end-stage renal disease access grafts for the repair of complex cardiac and vascular reconstruction surgeries. Since the Company’s inception in 1984, it is estimated that its products and tissues have been implanted in about 900,000 patients worldwide.

     

    CryoLife technology and products bring restoration and hope to people all around the world. CryoLife headquarters are located in Kennesaw, Georgia, a suburb of Atlanta.

     

    CryoLife is an Equal Opportunity/Affirmative Action employer.

    CryoLife is committed to the philosophy of equal opportunity employment. We do not discriminate against any employee or applicant.  All qualified candidates will receive consideration for employment without regard to race, ethnicity, age, religion, sex, sexual orientation, national origin, citizenship, disability, veterans or other legally protected status.

     

    Reasonable Accommodations
    CryoLife is committed to providing reasonable accommodations both in the application and interview process, consistent with legal requirements. If you need a reasonable accommodation while seeking employment, please email ADA_Accommodation@CryoLife.com or call 770-429-5215. A Human Resources representative will return your call. Messages or emails for any reason other than accommodation requests will not be returned.

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