• Collaborated with internal study directors to index, archive and destroy records according to the established retention schedule and corporate SOPs• Managed the issuance, location, custody and archival of laboratory notebooks utilized within the organization• Reviewed RTI project contracts for specifications related to electronic and physical document retention• Contributed to the establishment and alignment of procedures for the Versatile Enterprise record management system• Partnered with external vendors for destruction and long-term storage of records within external vendor databases

• Reconciled paper Trial Master File (TMF) files against DIA TMF Reference Model inventory trackers maintained in Excel for seven trials• Scanning of missing clinical documents, to ensure all documents are captured in the eTMF system• Ensured TMF adherence to established SOPs and all applicable regulations and guidelines, such as FDA regulations and/or ICH GCP guidelines, across the management of TMFs• Supported the Clinical Records Management team in the completion of required tasks for paper TMF closure• Maintained client and site confidentiality in a regulated environment

• Served as division system owner for two Learning Management Systems (LMS), which included uploading documents, maintaining user profiles and pulling reports for document and user training history• Authored Standard Operating Procedures (SOPs) and other controlled documents for internal business functions and use of Learning Management Systems• Executed aseptic gloving training and monitoring activities onsite at client locations• Collaborated with clients on the scheduling, creation, delivery, and implementation of customized training materials• Developed industry standard training material for cGMP, cGDocP, Data Integrity, Contamination Control, Aseptic Behavior and Technique, Environmental/Personnel Monitoring and Technical • Logistics Coordination (Technical and Non-Technical)o Planning/collaboration with sales and marketing teams for networking events, conference attendance and service sell sheetso Maintained office and aseptic gowning and cleaning supply levelso Coordinated with vendors for services required (maintenance, calibration, installations, etc.)

• Processed customer complaints relating to Albuterol inhalers• Analyzed complaint case reports from manufacturer to identify a course of action• Utilized TrackWise to monitor complaint type and individual batch trends• Communicated with manufacturer to ensure sample availability for testing• Batch Record Review

• Identified reference standards for product quotes by name/chemical structure• Managed database of highly characterized primary reference standards • Generated product quotes and Certificate of Analysis documentation as required• Worked with domestic and international suppliers including United States Pharmacopeia (USP), TLC Pharmaceutical Standards Ltd. and European Directorate for the Quality of Medicines (EDQM)• Tracked open orders for primary reference standards based on individual chemical synthesis lead time and the amount of characterization required• Received sales orders for suppliers separated by the license type to be exported under and prepared items from combined sales orders on a purchase order for the supplier once pricing and competitor pricing was confirmed for each item