Rachel Bone Email and Phone Number

• Coordinate / manage complaint files on behalf of manufacturing sites in compliance with cGMP, FDA and GSK requirements • Interact with pharmacists, customers and other medical professionals • Issue acknowledgement letters, retrieve samples for complaints received by GSK Response Center • Receive, log, route, investigate and/or review and close product complaint files received by approved generic distributors for injectables and nasal sprays• Contribute to Annual Product Reporting

• Investigated and documented customer complaints for all markets on behalf of GSK Zebulon Site for Solid Dose (SD) and Metered Dose (Aerosol) Inhaler (MDI) products • Investigated and documented quality, shipping, and distribution (etc) issues reported by other GSK Sites and /or Distribution Centers for all markets on behalf of GSK Zebulon Site for SD and MDI products • Implemented CAPAs based on substantiated incident trending and holding Expanded Investigation Team meetings• Contributed to Annual Product Reporting for SD and MDI Product Complaints using SAP, Excel and Statistica. Evaluated CAPA effectiveness and product trends• Performed annual statistical evaluation and calculation of complaint Lot Alert Limits and Substantiated Complaint Limit for SOP using SAP and Excel. • As Site Primary User for the Complaint Management System (CMS), trained new users, approved changes, maintained system for SKU and user accuracy• Site recipient of error messages related to interface and/or middle-ware problems between the SAP and CMS systems. Resolved errors on daily basis while ensuring GMP documentation of changes to electronic files• Compiled, analyzed data for metrics on monthly, quarterly and annual basis (where applicable) for all site products, occasionally presented data to senior management• Interacted with FDA and other regulatory inspectors• Contributed to Change Control Requests and SOP revisions• Possess high level technical knowledge of manufacturing processes, primary and secondary packaging processes, shipping, distribution, registered details, packaging technology, analytical testing methods, stability studies and product specifications • Continued as SAP trainer for Plant Maintenance and Quality Management

• Supported Environmental Monitoring (EM) Program for the manufacturing and packaging of Solid Dose, Aerosol and Dry Powder Inhaler production facilities • Supported USP Purified Water Monitoring Program for the manufacturing and packaging of Solid Dose products • Supported Critical Utilities Monitoring Program (compressed air, nitrogen, SD3A alcohol, purified steam, Analytical Chemistry water systems, ISO testing)• Actively trained new members and cross trained team on EM, Water and Utility programs including technique, site recognition, data entry, data analysis and equipment troubleshooting • Responsible for data entry, evaluation of trends and writing Technical Reports for EM, Water and Critical Utilities Monitoring Programs • Performed identification of recovered microorganisms using gross morphology, selective media, chemical tests and VITEK system• Performed Microbial Limits Testing (MLT) of bulk and finished Dry Powder Inhalers• Peer reviewed logbooks, SAP and LIMS data.• Supported SAP start-up as Super-User for Plant Maintenance. Trained team, assumed planner role in SAP managing maintenance plans/work orders for the EM, Water and Critical Utility monitoring programs• Became SAP trainer for Plant Maintenance and Quality Management in addition to Associate QC Scientist role

• Performed Microbial Limits Testing (MLT) for raw materials, in-process bulk and finished products for Solid Dose and Sterile Nasal Sprays• Performed Stability Testing for Sterile Nasal Sprays and Perineal / Skin Cleansers• Performed Environmental Monitoring (EM) and USP Purified Water Monitoring sampling and testing • Compiled, trended data for EM, Water Monitoring and Stability Testing • Prepared media, including growth promotion, pH and sterility testing• Identified recovered microorganisms using gross morphology, selective media, chemical testing and VITEK system. • Managed laboratory inventory and ordering of supplies• Performed preventative maintenance and calibrations for laboratory equipment