My next move will be to a biotech or medical device start-up with a high tech feel -- innovation, camaraderie, vision, optimism. I adapt to high-energy and inclusive corporate cultures. Is your company young-at-heart, hard-working, ambitious, and visionary? Do you want someone dedicated to cooperation, communication, accuracy, and efficiency? I can participate in Quality Assurance, Regulatory, and Engineering roles. Let's talk.
Since June 2013
Ensure Engineering Change Orders are compliant with QA, RA, R&D and EH&S regulations and coordinate efforts between Manufacturing, Planning, and Materials to meet manufacturing deadlines and market demand. Gather data, write justifications, model cost changes, and ensure that implementation plans work with production processes and timing. Provides engineering support on GTIN labeling compliance team. Investigate and write DRs, perform root cause analysis of CAPAs, write implementation plans of corrective actions and reworks. Supported manufacturing transfer of Quantase, a line of newborn screening tests for enzyme deficiencies, from Perth to Seattle. This project required the addition of 221 new parts, from enzymes to bottle caps, into the ERP system to create BOMs, cost analysis, and work orders to manufacture 12 catalog products. Managed writing and approval of GMP documents including purchase specs, MBRs and QC Test Methods. Coordinated efforts between QA, Manufacturing, and Planning for pilot run and supported senior engineers on final validations and financial report.
March 2013 --- May 2013
Rewrote training instructions and SOPs for Materials, Planning, Document Control, QA, and RA during transition from an outdated ERP system to SAP for finished goods inventory and distribution management. Three-month contract position via Kelly IT Resources.
Science & Math Presentation Designer
May 2012 --- March 2013
Contract assignment via Kelly IT Resources, supporting McGraw-Hill's CINCH project: • Edited, fact-checked and redesigned over 1000 middle and high school science and math presentations in Keynote. • Wrote digital presenter notes to accompany 150 algebra presentations. • Assisted in updating and maintaining online collection of presentations and notes.
Graduate Research Assistant, Storm Lab
June 2009 --- March 2012
• Developed protocol for immunofluorescent staining of neuronal melanocortin-4 receptors in mice • Independent design of experiments, analysis, and presentation of data • Led discussion and critiques of methods and conclusions in current literature • Trained and supervised undergraduate researcher • Pharmacology teaching assistant for pharmacy school; designed presentations and wrote quizzes • Designed and presented poster "Adenylyl Cyclase 3 and Obesity: Possible roles for AC3 in Leptin and MC4R Signaling" • Completed master's thesis entitled The obese, leptin-resistant, adenylyl cyclase 3 deficient mouse is responsive to melanocortin agonists.
Technical, Medical, and Instructional Writer
September 2005 --- December 2008
Wrote storyboard for multimedia, interactive tutorial for Treo 750. (Knowledge Anywhere) One year contract at Microsoft, interviewing MS Exchange Server subject matter experts to update, write, edit, and maintain troubleshooting guides for internal Exchange support. (Volt) Performed scientific literature research of clinical research data on GLP-1 analogues, vaccines, and anticonvulsant pharmaceuticals. (MedLitera) Wrote white paper for tight glucose control in the ICU and the mechanism of post-trauma hyperglycemia. (Publicis Dialog)
QA Technical Word Processor
April 2004 --- June 2005
Completed document change requests in FDA-regulated environment Edited standard operating procedures and manufacturing documents to meet cGMP standards Coordinated interdepartmental projects to remove obsolete documentation and increase accessibility to revisions
Quality Assurance Engineer
May 2000 --- December 2000
Performed functional and usability validation of web-based tools Created test strategies, wrote test procedures, and wrote system design document for test case database and bug tracking software Edited customer email alerts and web content
Instructional UI Developer | Server Software QA Analyst | Customer Care Specialist
January 1996 --- January 2000
Redesigned TV-Net instructional software and revised interactive help pages Wrote and executed test cases to validate client/server reliability and to improve user experience Wrote templates for email support, automated phone support, and FAQs Trained first-tier level customer service team Served as Quality Assurance contact for Customer Service issues Composed and edited customer newsletter articles
AdaptabilityFlexibilityIndependenceIndividualityInnovative thinkingInterest in knowledgeResiliencySelf-confidenceService orientedEfficiencyCuriosityCritical thinkingAnalytical thinkingApproachabilityAssertivenessAttention to detailAuthenticityCollaborationCoordinationCreative thinkingStrategic thinking
Confocal MicroscopyDiabetesIVDDiagnosticsNeuroscienceEndocrinology and metabolismMedical oncology ManfacturingMedical writingScientific WritingWriting Study Procedures and SOPsNew Drug Application (NDA)PMDImmunofluorescence Animal models Biochemistry Cell biology Diabetes Labtechnician Medical devices R&D Scientific writingAntibodiesBiological Drug DevelopmentBiotechnologyCancerCAPACell biologyCell CultureClinical pharmacologyClinical Study Design
Skills and Expertise
Write papers Create SOPsChange Control
Certificate in Biomedical Regulatory Affairs from University of Washington in 2015
Master of Science (M.S.) in Molecular Pharmacology from University of Washington in 2012
Certificate in Technical Writing & Communication from Bellevue College in 2011
Bachelor's Degree in Biology from University of Washington in 2008
BA in English from San Francisco State University in 1996