Sara Benson
Quality Assurance Associate @Keystone Industries
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WORK HISTORY
Quality Assurance Associate @Keystone Industries
Gibbstown, NJ, US
Ensure quality compliance for chemical and medical device processes involving polymer products, dental products, cosmetics, and water purification systems- Oversee internal audit systems, customer complaint handling, deviations, nonconformances, and CAPA systems- Manage supplier quality management system- Prepare and maintain product technical documents, validation documents, and other SOPs- Involvement in project planning, design control, and risk assessments- Ensure compliance with FDA 21 CFR 210 and 211, FDA 21 CFR 820, FDA 21 CFR 700 and 701, ISO 13485:2016, and ISO 22716.
EDUCATION
Penn State University
Bachelor's degree, Bioengineering and Biomedical Engineering
Moon Senior High School
High School Diploma
Penn State University
Master of Science - MS, Bioengineering and Biomedical Engineering
ABOUT SARA BENSON
My name is Sara Benson, and I am an experienced professional in the pharmaceutical and medical device field located in Philadelphia, PA. I hold expertise in cellular and gene-mediated pharmaceutical manufacturing, viral vector manufacturing, medical devices, FDA regulations and compliance, and quality event investigation. I thrive in a fast-paced environment with complex problems to solve. I hold a Master of Science in Biomedical Engineering from Penn State University, where I conducted research on the development and implementation of a machine learning algorithm designed to predict antimicrobial peptides targeting penicillin-resistant tuberculosis. I am deeply passionate about advancing life-saving treatments and am committed to making a meaningful impact in the field.
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