2018 -2023 Manager, Manufacturing, Science and Technology @
2014 -2018 Regulatory Compliance Specialist @
2013 -2014 Quality Investigator @
2012 -2013 Quality System Engineer @
2011 -2012 Product Quality Engineer @
2008 -2009 Teaching Assistant of SAP class(ISE583) @
2008 -2008 Teaching Assistant of Quality Management class(ISE527) @
Annie Lu Education
University of Southern California
Master of Science (Industrial and System Engineering)
2007-2009
Beihang University
Bachelor (Industrial Engineering)
2003-2007
Annie Lu Skills
Quality System
Quality Assurance
CAPA
Six Sigma
Quality Management
GMP
FDA
SPC
Lean Manufacturing
Design of Experiments
Change Control
Quality Control
Manufacturing
Quality Auditing
Validation
Statistics
21 CFR Part 11
Process Engineering
Continuous Improvement
Kaizen
Root Cause Analysis
Value Stream Mapping
Sop
Pharmaceutical Industry
ISO 13485
Medical Devices
Regulatory Requirements
FMEA
Industrial Engineering
ERP
Design Control
DMAIC
Engineering
Iso 9000
Minitab
SAP
LIMS
GxP
ISO 14971
Aseptic Processing
Trackwise
FDA GMP
Deviations
21 CFR
Aseptic Technique
GDP
V
Certified Quality Engineer (CQE)
Regulatory Submissions
Project Management
Annie Lu Summary
Annie Lu, based in Irvine, CA, US, is currently a Associate Director at Amylyx Pharmaceuticals. Annie Lu brings experience from previous roles at Amylyx Pharmaceuticals and Teva Pharmaceuticals. Annie Lu holds a 2007 - 2009 Master of Science in Industrial and System Engineering @ University of Southern California. With a robust skill set that includes Quality System, Quality Assurance, CAPA, Six Sigma, Quality Management and more. Annie Lu has 2 emails and 2 mobile phone numbers on RocketReach.
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