Results driven validation professional with a unique set of experience from both the laboratory and information systems side of the business. Hands-on experience implementing GMP systems with an emphasis on Chromatography Data Systems. Skilled at time management, execution, and customer service.
LabAnswer August 2014 - at PresentWorked with several Fortune 500 clients to provide solutions for global data systems including Waters Empower. Completed site implementations 2 months ahead of schedule using process improvements and code enhancements. Collaborated with client leadership to evaluate systems and processes and recommended improvements that saved over $25,000 per quarter. Managed projects for Empower Master Data configuration and validation and decreased overall project cycle time by 3 months for several sites across the globe. Created and validated over 100 custom calculations and reports using Waters Empower which saved clients 20% of man hours over manual spreadsheets. Created RFP's and SOW's with sales and management team which won new clients for the business. Trained and mentored junior consultants that support Agilent and Waters data systems.
Specialist IS Analyst
Amgen April 2013 - August 2014System analyst for CDS (Waters Empower and Agilent OpenLab), Electronic Notebook (Accelrys) applications. Implemented global chromatography system for sites in the United States, Puerto Rico, and Ireland that saved over 10% of man hours per month. Authored and executed validation protocols for clients, servers, and laboratory instruments including HPLC and GC. Created process for templating methods and analyzing data using custom code that saved over $10,000 per quarter and eliminated spreadsheets. Worked on a global team that developed a steamlined process for installing, testing and maintaining instruments.
Amgen May 2003 - April 2013Authored/executed validation documents including RD/IQ/OQ/PQ/VSR for various laboratory instruments including HPLC, GC and LCMS. Performed QA review of validation documents and worked with consultants to resolve deviations and errors. Responsible for systems throughout the SDLC including procurement, deployment, change control, training and maintenance activities. Worked with IS personnel to perform upgrades/downgrades and bug fixes for vendor software. Collaborated with various departmental teams to create/revise SOPs, job plans and training manuals. Used Visual Basic and Waters proprietary language to create over 200 custom templates for data gathering, calculations and reporting. Used Maximo and Trackwise for work order and non-conformance management.
Waters System Administration
Waters (On Site)
2012 - 2012
(1 year) Massachusetts
B.S. - Chemistry
University of Wisconsin-Madison
1993 - 1998
(5 years) Wisconsin