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Andrea D. De Lisle Fairfield, CA 94534 H: 707.428.0356 * Cell: 707.344.1452 Email: ad11799fa@westpost.

net ________________________________________ OBJECTIVE To obtain a position that will utilize my Manufacturing and QA experience to mee t objectives and support commitments to quality, compliance and continuous impro vement. WORK EXPERIENCE Began as a Quality Assurance Technical Reviewer in 2000 and worked over the next 10 years reaching management level with an outstanding track record of promotio ns and awards. EDUCATION Master of Arts in Organizational Management, University of Phoenix, December 200 3. Bachelor of Science in Biotechnology with emphasis in Microbiology and Fermentat ion, University of California, Davis, June 2000. Associates of Arts in General Science and Liberal Arts, Solano Community College , Fairfield, CA, May 1997. EMPLOYMENT HISTORY Title: Sr. Manager, Manufacturing Filling Operations Location: Bayer HealthCare, Emeryville, CA Duration: 06/2007-Present Job Duties: * Manages a 10 million dollar budget for Aseptic processing operations * Responsible for Aseptic processing operations which includes, filling, lyophil ization and oversealing * Knowledgeable regarding Filling equipment such as, lyophilizer, oversealer, vi al washer and CIP skid * Plan, manage and ensure that production schedule meet market demands * Work with the Production Planning, Formulation and Finishing departments to ac complish on-time production * Oversees the Filling department's shutdown activities * Write Annual Product Reviews for regulatory agencies * Initiate/ approve change control requests and document revisions * Give guided tours of Manufacturing departments * Performs Lean A3 and or Kepner-Tregoe Root Cause Analysis for critical discrep ant events and process improvements * Gather all pertinent information to create reports for presentation on departm ent objectives to senior management at quarterly measurement meetings * Communicates with engineering groups, finance department and senior management on departmental operations * Responsible for identifying and problem solving system issues, with recommenda tions to management * Conducts readiness for compliance and safety audits * Actively participates in regulatory and safety audits * Trains regular and new employees * Performance Award, Quality Assurance Award and Special Recognition Award * Supervise a staff of 42 * Knowledgeable regarding FDA and ICH Guidelines

Title: Sr. Validation Scientist, QA Location: Bayer HealthCare, Berkeley, CA Duration: 10/2006-06/2007 Job Duties: * Assisted Manufacturing in writing validation protocols * Approved validation protocols for Filling and Labeling/Packaging departments * Edited and approved regulatory reports for submission pertaining to the new Fi lling production plant * Approved change control requests * QA Person in the Filling/Finishing production plants * Co-wrote risk assessment SOPs for Filling and Labeling/Packaging departments Title: Associate Manager, Manufacturing Filling Operations Location: Chiron/Novartis, Emeryville, CA Duration: 4/2005-10/2006 Job Duties: * Responsible for Filling operations (including scheduling Filling activities) * Investigated and wrote discrepancy reports * Wrote new and revised procedures * Trained employees on new and revised procedures * Responsible for 10 employees * Initiated change control requests Title: Specialist II, QA/QC (QA Inspection Supervisor) Location: Chiron, Emeryville, CA Duration: 4/2004 - 04/2005 Job Duties: * Assisted in the development, revision, application, maintenance and review of quality standards * Documented and applied methods to visual inspection of incoming materials, bul k intermediates and final dosage products * Created, implemented and supported quality and manufacturing systems that were related to Inspection, Clinical and Labeling/Packaging activities * Provided support to Manufacturing and Clinical departments for Line Clearances and QA Sampling Inspections (AQLs) * Wrote discrepancy reports Title: Quality Assurance Manager Location: BioMarin Pharmaceutical, Novato CA Duration: 08/2003 - 4/2004 Job Duties: * Responsible for overseeing Batch Record review, release of Raw Materials maintained Reserve/Retain Sample inventory * Responsible for label templates and issuance of in-house labels * Wrote new and revised procedures * Audited raw material vendors * Wrote discrepancy reports Title: Quality Assurance Supervisor, Location: BioMarin Pharmaceutical, Novato, CA Duration: 08/2001 - 08/2003 Job Duties: * Approved and released raw materials and maintained Reserve/Retain Samples * Responsible for label templates and issuance of in-house labels


* Maintained inventory of rejected and expired raw materials for either R & D or disposal * Scribed during audits by regulatory agencies * Audited raw material vendors Title: Quality Assurance Technical Reviewer Location: BioMarin Pharmaceutical, Novato, CA Duration: 10/2000 - 08/2001 Job Duties: * Reviewed batch records and QC results pertaining to fermentation, purification and formulation processes SKILLS Computer: Word, Excel, Microsoft Project, Laboratory Information Management Syst ems (LIMS), Electronic Document Management Systems (Trackwise and SCORE), Visio and PowerPoint. References available upon request