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Career Overview
16 years customer support in software application usage and training
11 years biopharmaceutical support including GMPs, CFR 21 Part 11, SOPs
11 years Operational Excellence and Continuous Improvement experience 5 years Operational Excellence lead experience, including cross functional team lead
3 years business owner of an electronic laboratory notebook application Six Sigma Green Belt - Amgen, Inc.
Qualifications
Microsoft® Office Suite: Word, Excel, PowerPoint, Visio, Access, Project
Waters Vision Publisher (ELN) SME
Visual Basic for Applications
SQL
Minitab
Work Experience
2012 to CurrentSr. Associate Global Analytical SciencesAmgen | City, STATE,
Drug Substance and Analytical Sciences Operational Excellent Lead - Identified and translated traditional OE tools developed for routine work into tools for teams that are project, non-routine based work.
Translated and supported adoption of OE practices across the organization.
Waters Vision Publisher Electronic Laboratory Notebook Site Business Owner - Trained new staff on use and compliance requirements in using the system; supported technical troubleshooting, translated business needs into procedure; supported technical teams and communicated needs to users; implemented process improvements for documentation practices; assisted in identifying a defect affecting functionality of the application across multiple sites.
Work Center Team Lead - Led a cross-functional work center team for sample management to identify, address, and improve the transition of shipments from the QC, highly regulated environment into the less regulated Process Development environment.
Solutions implemented improved transition of shipments to less than two days 90% of the time.
Developed an extended forecasting tool using Excel and VBA, avoiding a $60,000 application purchase and ongoing yearly service contract fees.
Developed an Excel tool using VBA which allowed Utility Operators to quickly access contacts for controlled temperature units when they went into alarm and removed the need to maintain paper documents that were frequently found to be out of date.
This tool assisted the Operators with units in three buildings and two functional areas at the Longmont Campus.
2009 to 2012Sr. Associate P&PE Analytical SciencesAmgen | City, STATE,
Waters Vision Publisher Power User - Standardized templates used during analysis, reducing resources spent documenting and reviewing by up to 40%.
System Owner for Equipment - Restructured and consolidated the pipette maintenance system, resulting in a reduction of lost pipettes and improved turnaround times for periodic maintenance.
Reduced the number of pipettes maintained on paper by 50% by inactivating unused or lost pipettes.
Operational Excellence Analytical Sciences Representative - Championed Analytical Science needs on the Process & Product Engineering OE team as well as application of OE practices and tools in the AS organization.
Ensured that opportunities to recognize and share knowledge were pursued.
01/2007 to 01/2009Sr. Associate Laboratory AnalystAmgen | City, STATE,
Identified process improvements to improve daily functionality.
Implemented visual tools to identify equipment that was out of service.
01/2003 to 01/2007Sr. Associate Quality ControlAmgen | City, STATE,
Sample Management and Release Resource Scheduling and Planning Lead - Participated in the standardization of time accounting across multiple sites.
Monthly prepared and reviewed forecasting estimates needed to support analytical testing and project work.
Supported the interface between manufacturing and the analytical labs by receiving distributing, and shipping samples.
Improved processes for long term storage and inventory maintenance, including disposing of expired reserves.
Developed a process to electronically maintain contact information for controlled temperature units in the QC laboratories.
This system provided a single location for the Utility Operators to access contacts when units alarmed rather than the outdated, difficult to maintain paper system in place.
Developed a reserve inventory database in Access which provided a quick reference to the amount of material available for reserve requests and the location of the reserves.
Awarded a Gold Atlas in 2005 for the database.
Education and Training
Expected in 2012Bachelor of Science | Information TechnologyColorado State University Global Campus, Greenwood Village, COGPA:
Information Technology
Expected in 1995Associate of Applied Science Radiography | Northern New Mexico Community College, Espanola, NMGPA:
Skills
accounting, Business Owner, database, documentation, Excel and VBA, forecasting, functional, inventory, Team Lead, Access, Excel, Office Suite, PowerPoint, Publisher, Word, Minitab, Process Development, processes, quick, receiving, Scheduling, shipping, SQL, troubleshooting, VBA, Visio, Vision, Visual Basic for Applications
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