Skills

Application of Lean and Six Sigma tools

oAssisted in DMAIC meetings as a Subject Matter Expert

oLead improvement projects

Application of Root Cause Analysis

Using statistical tools to provide trend analysis

Software

•Microsoft Office •SQL Laboratory Information Management System •SAP Crystal Reports

•TrackWise 8 Quality Tracking System •JD Edwards EnterpriseOne

Experience

Quality Control Analyst II Nov 2015 Present

Baxalta/Shire PLC, Thousand Oaks, CA

Investigated laboratory errors due to atypical assay results

Authored validation reports regarding environmental monitoring and bioburden testing

oUsed statistical process control tools to analyze and establish environmental monitoring alert levels

Worked with validation to execute validation studies and new assay development

Supported in team discussions for continuous improvement

Compiled environmental monitoring and bioburden testing trending reports and presented at the Quarterly Management Review

Representative for EHS department meetings

oPerformed internal laboratory audits and ensured laboratory meets safety requirements

Performed sterility testing on harvest samples and lyophilized product

Performed identification of bacterial isolates

Performed growth promotion and media qualification testing

Quality Control Analyst I March 2013 Nov 2015

Baxter Bioscience/Baxalta, Thousand Oaks, CA

Issued alert and nonconformance reports in response to result limits

Issued and tracked work orders through JD Edwards

Performed environmental monitoring of cleanroom areas (aseptic filling area and non-aseptic filling area)

Performed routine bioburden water testing and in process sample testing

Used computer systems to collect and record data (LIMS system)

Education/Certification

University of California, Irvine Sep 2005 Mar 2009

Irvine, California

Bachelor of Science Degree in Biomedical Engineering

Member of the American Society of Quality Oct 2017-Current

Certified Six Sigma Green Belt Dec. 12, 2017

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