Julie-Anne Burdick
Product Quality Assurance Manager @AbbVie
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WORK HISTORY
Product Quality Assurance Manager @AbbVie
Worcester, MA, US
Manage quality oversight of cGxP contract manufacturing organization (CMO) and contract laboratory organization (CLO) for third-party pharmaceutical company’s drug products and drug substances manufactured in the Worcester facility. Review unexecuted master batch records and executed batch records for GMP production. Lead investigations into good manufacturing practice (GMP) related issues identified during audits, batch records reviews using TrackWise. Manage and review deviations, change controls, corrective action and preventive actions (CAPAs), and effectiveness checks to ensure on-time closure.
EDUCATION
University of Maine
Bachelor of Science - BS, Chemical Engineering
Arizona State University
Doctor of Philosophy - PhD, Bioengineering and Biomedical Engineering
Clemson University
Master of Science - MS, Bioengineering and Biomedical Engineering
SKILLS
ABOUT JULIE-ANNE BURDICK
Highly skilled quality assurance professional in ISO 9001:2015 (comparable to AS9100), ISO 17025, ISO 13485 Quality Management System documentation, document preparation, audits, supplier management, and risk management. Experienced bioprocess engineer with an extensive technology background in biotech startup, academic, and life science organizations. Excellent communication, organization, and time-management skills; self-motivated, work well both independently and collaboratively on project teams with diverse disciplines. Demonstrated research, development and process engineering expertise in new products for injectable therapies, medical devices, and regenerative medicines for clinical applications. Recognized accomplishments in filtration product development and novel application test method design. Managed intellectual property documentation. Skills: Process development and optimization, Product development & characterization: hollow fiber filter, flat sheet membrane; biomaterial, cytotoxicity & biocompatibility evaluations; Cell culture: primary tissue & cell harvest (pericardium, kidney, cartilage), cell-lines, primary cells, stem cells, aseptic technique, bioreactors, microcarriers; characterization techniques: cell-based assays, monoclonal antibodies, vaccines, protein detection and DNA assays, Western blots, SDS-PAGE, ELISA, histology, microscopy, immunohistochemistry.
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