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QA Associate

Eurofins USA PSS Insourcing Solutions

QA Associate

Sanford, NC
Full Time
Paid
  • Responsibilities

    Job Description

    Sanford site is a complex multi-product, multi-host biotech manufacturing site that manufactures clinical and commercial Vaccine and Gene Therapy products.  The position will support the Sanford, NC Quality Operations department by performing Quality Assurance material enrollment and supplier qualification activities associated with clinical and/or commercial products.  

    The individual should be able to demonstrate the following:

    • Act safely, know, and follow all EH&S safety requirements for site
    • Display knowledge in cGXP, materials, components, and supplier management.
    • Excellent written and verbal communication and interpersonal skills
    • Ability to organize self and track status of assigned actions across multiple products
    • Organizes and provides written and/or oral presentations of work with minimal input.
    • Provides support for QA material enrollment and supplier qualification activities
    • Can identify and implement new processes and programs for quality improvement.
    • Contributes to the interpretation of cGXPs for the commercial and clinical environment.
    • Independently reviews working instructions/global procedures for technical content across multiple subject areas.
    • Interfaces with other parts of the organization such as research and development groups. Able to work outside immediate subject area, supporting a wider range of customers of differing subject areas and locations.
    • Develops ability to train other team members on tasks
    • Able to resolve complex issues with minimal assistance from management. Represents Quality Assurance in cross-departmental/cross-site/cross-network meetings.
  • Qualifications

    Qualifications

    • 3-5 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field
    • 1-3 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field
    • Preferred experience with: Global Quality Tracking System (Trackwise TM application); Systems, Applications, and Products (SAP), Microsoft Office™ applications, specifically Word, Excel, and PowerPoint; Lean/Six Sigma/DMAIC concepts; and Quality Risk Management Authorization to work in the United States indefinitely without restriction or sponsorship

    Additional Information

    Position is full-time, Monday - Friday 8:00am - 5:00pm.  Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply.

    • Excellent full time benefits including comprehensive medical coverage, dental, and vision options
    • Life and disability insurance
    • 401(k) with company match
    • Paid vacation and holidays

    EUROFINS IS A M/F, DISABLED, AND VETERAN EQUAL EMPLOYMENT OPPORTUNITY AND AFFIRMATIVE ACTION EMPLOYER.