CryoLife

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HTQA Associate

at CryoLife

Posted: 6/8/2019
Job Reference #: 2183
Categories: Retail

Job Description

  • Posted Date1 month ago(5/15/2019 9:47 AM)
    Job ID
    2019-2183
    Job Location
    US-GA-Kennesaw
    # of Openings
    1
    Category
    Quality Control
  • 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

    • 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.
    • Responsibility and authority to approve nonconformances, determine training competencies, approve engineering change notices, approve document revisions.
    • Perform final/terminal release of tissue that flow through the HTQA department.
    • 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) or equivalent/relevant experience.
    • Strong communication skills, strong mathematical skills, and the ability to communicate and interface with people at all levels.

    Company Info

    Who We Are.

    CryoLife is one of the world’s leading contemporary medical device companies whose technology and products bring restoration and hope to people all around the world. With a variety of innovative products and technologies available, including preserved human cardiac and vascular tissues, surgical adhesives and sealants, and mechanical heart valves, our mission is to restore the health of patients by delivering innovative technologies of unsurpassed quality. Since our inception in 1984, it is estimated that our products and tissues have been implanted in over 1 million patients worldwide. Headquartered in Kennesaw, Georgia, CryoLife employs over one thousand people from various education and experiential backgrounds across the United States and internationally.

    CryoLife is an Equal Opportunity/Affirmative Action employer.

    CryoLife provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

    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.