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Advatix LATAM · 1 month ago

Quality Assurance Associate

Zanesville, OH

Full-time

Onsite

Senior Level

5+ years exp

Advatix LATAM is seeking a Quality Assurance and Regulatory Compliance Associate who will oversee all Quality Assurance activities for their assigned Distribution Center. This role involves managing the Quality Management System, ensuring compliance with regulatory standards, and leading preparations for regulatory inspections.

Transportation/Trucking/Railroad

Responsibilities

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