• Quality Assurance Associate

    Advatix, Inc. (Breinigsville, PA)


    Quality Assurance and Regulatory Compliance Associate

    Role Summary

    The QARC Associate oversees all Quality Assurance activities for their assigned Distribution Center. This position serves as an interface for the Food and Drug Administration (FDA) and ISO and other state, and local regulatory inspections and communications related to client needs. The scope of the position includes ensuring that Quality Programs, systems for clients, and software meet all applicable regulatory requirements and are consistent with internal QA goals and initiatives. This role is

    Key Results Area

    + Manage and maintain the Quality Management System at the distribution center

    + Ensure the Quality Management System is maintained in support of the ISO Program for the client, including but not limited to an effective and compliant Corrective Action/Preventative Action Program (CAPA). Verifies that appropriate follow-up and corrective action is taken because of audit observations and investigations

    + Responsible for adhering to and maintaining a standardized format and process for documenting the Company's Standard Operating Procedures (SOPs) and Work Instructions (WI) and ensuring that the associated document approval and control measures are being followed per the regulatory standards

    + Communicate with Senior Management regarding the status of the Quality Management System, such as corrective actions, process updates, risk analysis, improvement initiatives, licensing, and other relevant information

    + For the client's needs, lead internal and external preparations for ISO and other regulatory inspections; serve as the company interface on compliance matters and respond to inspectional observations; serve as lead Quality representative during client and health agency inspections

    + All other duties as assigned

    Skills & Qualifications

    + A bachelor's degree preferred or relevant experience

    + 5+ years of QA or compliance experience with ISO

    + Experience with maintaining Quality Management Systems, Document Control Systems, and other good quality practices in handling finished goods.

    + Experience with quality policies and metrics

    + SSAE/SOC and ISO knowledge preferred

     

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