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@aliciasonne1
I am an experienced quality assurance leader in pharmaceutical and 3PL compliance.
I manage all aspects of quality management for large 3PL warehouses, overseeing operations that include cold chain, controlled substances, biologics, medical devices and animal health products for multiple active accounts.
I lead multidisciplinary investigations from root cause analysis through corrective/preventative action implementation and effectiveness verification, and I regularly host audits for clients, regulatory agencies and corporate auditors.
I am proficient with SmartSolve and Microsoft Office and well versed in ISO 9001, ISO 13485, 21 CFR compliance and 3PL licensing requirements; I also assisted with QMS implementation in a new million-square-foot warehouse.
I drive KPI trending and presentations, document control, training programs and inspection/release activities, and I build and develop quality teams focused on compliance, continuous improvement and operational excellence.
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Work history, roles, and key accomplishments
Arvato Bertelsmann
Mar 2018 - Nov 2018 (8 months)
Managed the Quality Management System for a 3PL warehouse with 5 active accounts distributing electronics, gaming systems, and cell phones. Updated SOPs, hosted management reviews and led the ISO 9001 recertification audit resulting in only 2 minor findings and implemented effective corrective actions.
Degrees, certifications, and relevant coursework
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