Shelly Lapointe Email & Phone Number
Quality Systems Director
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Shelly Lapointe Location
- San Diego, CA, US
Shelly Lapointe Work
- 2026 -now Quality Systems Director @ Advanced AI (Stealth Startup)
- 2020 -2026 Director, IT Quality, Regulatory and Validation Technologies @
- 2018 -2020 Senior Manager, IT Quality – Computer System Validation @
- 2015 -2017 Senior Manager, Quality Systems @
- 2013 -2015 Quality Assurance Data Systems Manager @
- 2006 -2012 Lead Quality Systems Analyst @
- 2004 -2006 Quality Systems and Compliance Specialist @
- 2002 -2004 QC Analyst II and Sample Coordinator @ Abgenix Inc.(now Amgen)
- 1999 -2000 Extrusion Lab Administrator @
- 1995 -1998 Government Property Administrator and Document Control and QC and Payroll @
Shelly Lapointe Education
- Ashford University
MA (Educational/Instructional Technology)
2008-2010 - University of California, Santa Cruz
Certificate (Biotechnology)
2004-2005 - San Jose State University
BS (Biology & Chemistry)
2000-2002 - De Anza College
(Chemistry)
1993-1999 - University of California, Santa Cruz
(Biology)
1992-1993
Shelly Lapointe Skills
- Perseverance
- Determination
- Problem Solving
- Validation
- Livelink
- SAP
- SharePoint
- Documentum
- Six Sigma
- LIMS
- Bioassay
- Technical Training
- FDA
- Software Documentation
- Change Control
- Quality Assurance
- Pharmaceutical Industry
- Trackwise
- Biopharmaceuticals
- Medical Devices
- 21 CFR Part 11
- HPLC
- Quality Control
- CAPA
- Quality System
- GMP
- SOP
- Biotechnology
- GLP
- Life Sciences
- Technology Transfer
- Computer System Validation
- Laboratory
- Management
- GxP
- R&D
- V&V
- Standard Operating Procedure (SOP)
- Laboratory Information Management System (LIMS)
- Corrective and Preventive Action (CAPA)
- Good Laboratory Practice (GLP)
- U.S. Food and Drug Administration (FDA)
- Quality Auditing
- Cross-functional Team Leadership
- Regulatory Affairs
- Pharmaceutics
- Clinical Trials
- Testing
- U.S. Title 21 CFR Part 11 Regulation
- Standard Operating Procedure Sop
- Strategic Planning
- Process Improvement
- Microsoft Excel
- u.s. Food and Drug Administration Fda
- Cross Functional Team Leadership
- Good Laboratory Practice Glp
- Corrective and Preventive Action Capa
- Quality Systems
- Laboratory Information Management System Lims
- Standard Operating Procedure
- Laboratory Information Management System
- Corrective and Preventive Action
- u.s. Food and Drug Administration
- Good Laboratory Practice
Shelly Lapointe Summary
- Shelly Lapointe, based in San Diego, CA, US, is currently a Quality Systems Director at Advanced AI (Stealth Startup). Shelly Lapointe brings experience from previous roles at Thermo Fisher Scientific, Pacira Pharmaceuticals, Inc. and Arena Pharmaceuticals. Shelly Lapointe holds a 2008 - 2010 MA in Educational/Instructional Technology @ Ashford University. With a robust skill set that includes Perseverance, Determination, Problem Solving, Validation, Livelink and more. Shelly Lapointe has 1 mobile phone numbers on RocketReach.
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