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    Validation Support Specialist - Durham, United States - Novacares

    Novacares
    Novacares Durham, United States

    3 weeks ago

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    Description

    Nova Biomedical is an Equal Opportunity Employer in compliance with Affirmative Action in hiring and promoting women, minorities, veterans and individuals with disabilities.

    **Validation Support Specialist - Raleigh/Durham**

    **Department:** Field Service-Southeast **Location:** Raleigh, NC

    Nova Biomedical is looking for a Validation Support Specialist to provide field support in the Raleigh/Durham, North Carolina area to some of the industrys leading pharmaceutical and biotechnology companies. This is a terrific opportunity to grow with a market leading medical device company. Here is a link to the video to learn more about our latest product that this role will support:

    In addition to comprehensive benefits, this role offers dedicated use of a company car to travel. At times, this role will require national travel.

    ***Primary Responsibilities:***

    Provide Installation, Installation Qualification and Operational Qualification (IQOQ) and training support on BioProfile company product lines to customers.

    Manage field support requirements associated with BioProfile system installations and validations.

    Drives key performance indicators (KPIs) locally to ensure a high level of customer satisfaction.

    Performs on-site support for applications and sales activities for new product installations and demonstrations.

    Responsible for properly reviewing, completing and returning/submitting service documentation and regulatory paperwork (electronic and hard copy) to satisfy U.S. FDA requirements.

    Involved with cross-functional teams in resolving issues related to critical products and high profile customers.

    Conducts in-house and field-based validation training for Nova personnel as needed.

    ***Qualifications:***

    BS in Biology, Chemistry, Bioengineering or related field.

    2+ years of exerience working with cGMP equipment validation in the biotech / pharma field.

    Strong understanding of U.S. FDA regulatory requirements for the development of Biotech/Biopharmaceutical drug therapies.

    Strong understanding of U.S. FDA 21CFR Part11 Guidelines as they apply to Biotech/ Biopharmaceutical manufacturing.

    Strong understanding of current Good Documentation Practices and exceptional documentation skills.

    Nova Biomedical, international and privately held company, is a world leader and innovator in biosensor technology. We are the largest privately owned in vitro diagnostics (IVD) company in the U.S., and the third in the world, with over 1,200 employees.

    Highlights of benefits offered to Nova Biomedical employees include Blue Cross Blue Shield medical plan, tuition reimbursement, matching 401K, delicious and company subsidized cafeteria and an innovative scholarship program for children of employees.

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