“Responsible for the preparation of information, records and instructions for review and approval of paper-based and electronic Manufacturing batch records and associated documents. Responsible for supporting any training of Master Batch Record templates."Functioned as the company’s only full-time batch record author, utilized MasterControl’s MES Batch Record system to build electronic batch records compliant with current GMP standards in multiple manufacturing facilities.Primary focus was to transition and migrate the company from an established paper-based batch record system to a digital electronic batch record system utilizing the cloud-based Production Record building environment.While performing job duties, successfully collaborated on an ongoing basis with multiple departments including Quality Assurance, Quality Control, Training/Human Development, IT/IS, Production, Logistics, and Process Technologies. Successfully transitioned eight paper production batch records to electronic batch records and built another six electronic batch records, including 40-85 page equivalency reports written and submitted for collaboration for each transferred process.Authored, revised, and collaborated regularly on master production records, SOPs, forms, protocols, and reports.

Moved with company from Chicago, Illinois, Mankato, Minnesota, Allentown, Pennsylvania