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OBJECTIVE: QC systems lead with 5 years of experience implementing, validating and maintaining QC computer systems and associated laboratory

equipment is looking to relocate for a computer validation or implementation position. EDUCATION: Bachelor of Science, Microbiology, 1995-2007 University of New Hampshire, Durham, NH EMPLOYMENT: 9/01-present: QC Lead, Lonza Biologics Inc, 101 International Drive,Portsmouth, NH 03801 * Writes and reviews validation life cycle documents for QC laboratory computer systems. This includes configuration specifications, administration guides, validation protocols, validation master plans, summary reports and trace matrices. * Executes Installation and Operational Qualifications, disaster recovery and change management testing protocols for QC computers and servers. * Maintains system configurations within validated state and performs changes per applicable change management polices including writing of change controls and performing the associated testing. * Primary administrator for all computer systems within the QC laboratory. * Creates and maintains user accounts on all laboratory computer systems according to relevant standard operating procedures. * Manages data generated by laboratory computer systems using different backup and archival applications. * Works with laboratory analysts to resolve technical problems related to QC specific application and instrumentation. This includes application specific errors, instrument connectivity and general performance issues. * Interacts with IT department to ensure laboratory requirements and systems receive the required level of support. * Planned, implemented and qualified the QC Local Area Network (LAN). Maintains the qualified state of the QC LAN by adhering to applicable polices, completing required change forms and performing the periodic review. * Plans documentation and resources necessary for system implementations. * Acted as liaison between Manufacturing, Validation, Engineering, Compliance and the Quality Control labs during start up and validation of new biopharmaceutical plants' utility systems. o Responsibilities included: development and implementation of environmental monitoring program within new facility (revision and development of SOP's and test methods), reviewed OQ and PQ documents for production related plant

utilities, developed and executed project plan for PQ testing of utility systems. o Familiar with ISO 14644, USP, EP, Annex 1 (EMEA cGMP's) and Q7A. * Currently supports the following QC laboratory systems: Softmax Pro (versions 4.6 and GXP 5.3),Data Pro 800 and 900, Data Guard, Statlia, KC3, Unicorn, 32 Karat, Quantity One, SOLAAR, Endoscan V, WinKQCL, Microseq, Sampler Sight Pharma, Varian Cary WinUV, Thermo LIMS, Chromeleon, Cerity CDS, Park & Elmer Winlab UV. Works with the following IT and Enterprise applications: