2000 -
2006 Project Manager and Site Validation Manager @ GXP Biopharm
1998 -
2000 Validation Engineer @ Raytheon Engineers and Constructors
1996 -
1998 QC Chemist @
Charles Lu Education
Loyola Marymount University
Bachelors of Science (Biochemistry)
1991
-
1996
Charles Lu Skills
ITIL Certified
Good Laboratory Practice Glp
Computer System Validation
GMP
GAMP
GxP
Biotechnology
ICH guidelines
Change Control
Astm E2500
Validation
Trackwise
Process Improvement
Engineering
Quality Assurance
Q10
Corrective And Preventive Action Capa
Quality System
Microsoft Office
Iso 13485 And 14971
V&V
Biopharmaceuticals
Annex 11
Fda Guidelines 21 Cfr Part 11
Customer Service
U.S. Food And Drug Administration Fda
Project Planning
Regulatory Submissions
Standard Operating Procedure Sop
Quality Control
Technology Transfer
Aseptic Processing
GLP
EMA
LIMS
Ich Guidelines Q7A
CAPA
Architecture
Quality Systems
FDA
Sop
21 CFR Part 11
ISO 13485
Cleaning Validation
u.s. Food and Drug Administration
Corrective and Preventive Action
Standard Operating Procedure
Good Laboratory Practice
Charles Lu Summary
Charles Lu, based in San Gabriel, CA, US, is currently a Director Of Quality Assurance at BioAtla, Inc.. Charles Lu brings experience from previous roles at Carlsbad Tech, Bayer, QMS Compliance Consulting, Inc. and Integrity Bio. Charles Lu holds a 1991 - 1996 Bachelors of Science in Biochemistry @ Loyola Marymount University. With a robust skill set that includes ITIL Certified, Good Laboratory Practice Glp, Computer System Validation, GMP, GAMP and more. Charles Lu has 3 emails and 2 mobile phone numbers on RocketReach.
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