Quality Assurance - Biotech Resume Search
Quality Assurance - Biotech Resume Search
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Quality Assurance Resume


Desired Industry: Biotech SpiderID: 50440
Desired Job Location: Los Angeles, California Date Posted: 4/27/2011
Type of Position: Full-Time Permanent Availability Date: immediately
Desired Wage:
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel: Yes, More Than 75%
Highest Degree Attained: Doctoral Willing to Relocate: Yes


Objective:
Applied Statistics Manager. Make decisions based careful/accurate analysis of data. Can help on a momentís notice. Process control, process optimization, sampling, surveys, product quality confirmed in support of marketing, improve measurement systems and reduce production waste.


Experience:
14 years Biotech, Pharma, Devices (including private consulting business).
Knowledge of US FDA regulations and guidances on validation and verification as well as Quality by Design.
Hands on experience with product stability-expiry, product complaints analysis and managing the Annual Product Review process


Education:
BA Biology, UCSD, La Jolla, California
MA, PHD, Biology, Harvard, Cambridge, Massachusetts


Affiliations:
American Society for Quality


Skills:
Quality Engineering, Process Optimization (Statistically Designed/Analyzed Experiments), Process/product capability (meeting specifications), Statistical Process Control (SPC), Measurement System Improvement/ Calibration, Research, Study Design, Quality Assurance, Quality Control, Sampling for Quality Analysis and Product Disposition, Survey Development/ Analysis, Six Sigma, Design for Six Sigma, Risk Analysis and Mitigation -HAACP, -FME(C)A, -FTA, Corrective Action Preventive Action (CAPA) Systems, Root Cause Analysis, Analytical Method Qualification/ Validation/ Verification, Process Transfer (Equivalency Methods), CMC review, Outlier Analysis, Out-of-Trend, (OOT), Out-of-Spec (OOS) and nonconformance investigations, Technical Writing, Data Migration, Bioburden, Shipping (cold-chain) Validation, Formulation Development (mixture analysis) and Project Management.


Reference:
Available upon request.


Candidate Contact Information:
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