Genevieve Stever
Manager, Manufacturing Engineer @LOTTE Biologics
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WORK HISTORY
Manager, Manufacturing Engineer @LOTTE Biologics
Author and lead cross-functional teams through execution of change controls in Quality Management System (QMS) to enhance robustness of manufacturing processes. • Core team member for implementation of new Document Management System (DMS) and QMS. • Prepare and review new product documents, such as technology transfer reports, bill of materials, standard operating procedures (SOPs) and manufacturing batch records (MBRs).• Provide on-call support and floor support during process start-ups to troubleshoot manufacturing issues and provide compliant solutions.• Provide backroom support for client audits and regulatory health authority inspections by fulfilling and balancing multiple requests. • Serve as site self-inspection audit team member to identify observations, recommendations and necessary corrections to uphold compliance and product quality. • Completed a 3-month rotation with QA Compliance (July-September 2023). Responsibilities included: review of electronic change controls (eCC) for accuracy and compliance, participation in DMS / QMS pressure testing and configuration builds and approval of eCC extension requests and multi-phased records in QMS.
EDUCATION
University at Buffalo Pharmacy and Pharmaceutical Sciences
Bachelor of Science - BS, Pharmaceutical Sciences
ABOUT GENEVIEVE STEVER
Dedicated manufacturing engineer professional who is motivated to contribute, learn and grow in the biopharmaceutical industry. Passionate about adding to my teams overall success, demonstrated through excellent communication, organizational skills and attention to detail. Experienced in change control process and authoring procedures to drive continuous improvements.
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