Resumes
Resumes
Senior Regulatory Affairs Specialist At One Lambda, Inc
View pageLocation:
933 Fawnglen Pl, Newbury Park, CA 91320
Industry:
Medical Devices
Work:
One Lambda, Inc. | A Thermo Fisher Scientific Brand
Senior Regulatory Affairs Specialist at One Lambda, Inc
One Lambda, Inc. Jan 2015 - Apr 2017
Engineer and Scientist Ii, Qc
One Lambda, Inc. | A Thermo Fisher Scientific Brand Jan 2015 - Apr 2017
Engineer and Scientist Iii, Qc
One Lambda, Inc. Jan 2013 - Aug 2013
Qc Associate
One Lambda, Inc. | A Thermo Fisher Scientific Brand Sep 2010 - Jan 2013
Laboratory Associate Iii
Senior Regulatory Affairs Specialist at One Lambda, Inc
One Lambda, Inc. Jan 2015 - Apr 2017
Engineer and Scientist Ii, Qc
One Lambda, Inc. | A Thermo Fisher Scientific Brand Jan 2015 - Apr 2017
Engineer and Scientist Iii, Qc
One Lambda, Inc. Jan 2013 - Aug 2013
Qc Associate
One Lambda, Inc. | A Thermo Fisher Scientific Brand Sep 2010 - Jan 2013
Laboratory Associate Iii
Education:
California State University Channel Islands 2019 - 2022
Master of Science, Master of Business Administration, Masters, Business Administration, Biomedical Engineering, Biotechnology University of California, Los Angeles 2007 - 2010
Bachelors, Bioengineering Moorpark College Business Administration 2004 - 2007
Master of Science, Master of Business Administration, Masters, Business Administration, Biomedical Engineering, Biotechnology University of California, Los Angeles 2007 - 2010
Bachelors, Bioengineering Moorpark College Business Administration 2004 - 2007
Skills:
Gmp
Validation
Biotechnology
Medical Devices
Gel Electrophoresis
Quality System
Pcr
Molecular Biology
Capa
Quality Control
Fda
Laboratory
Assay Development
Dna
Lifesciences
V&V
Cell Culture
Life Sciences
Standard Operating Procedure
Microsoft Excel
Sds Page
Protein Chemistry
Polymerase Chain Reaction
Microsoft Office
Fda Gmp
Engineering
Design Control
Qpcr
Elisa
Data Analysis
Quality Assurance
Product Development
Iso Standards
Biochemistry
Sap
Minitab
Leadership
In Vitro Diagnostics
Ngs
Advertising
Small Business Marketing
Brand Management
Content Marketing
Digital Marketing
Enterprise Marketing
Product Management
Public Relations
Business Strategy
Cell Based Assays
Excel
Microsoft Office 2007
Erp
Software Documentation
Agarose Gel Electrophoresis
Glp
Sop
Hplc
Lims
Validation
Biotechnology
Medical Devices
Gel Electrophoresis
Quality System
Pcr
Molecular Biology
Capa
Quality Control
Fda
Laboratory
Assay Development
Dna
Lifesciences
V&V
Cell Culture
Life Sciences
Standard Operating Procedure
Microsoft Excel
Sds Page
Protein Chemistry
Polymerase Chain Reaction
Microsoft Office
Fda Gmp
Engineering
Design Control
Qpcr
Elisa
Data Analysis
Quality Assurance
Product Development
Iso Standards
Biochemistry
Sap
Minitab
Leadership
In Vitro Diagnostics
Ngs
Advertising
Small Business Marketing
Brand Management
Content Marketing
Digital Marketing
Enterprise Marketing
Product Management
Public Relations
Business Strategy
Cell Based Assays
Excel
Microsoft Office 2007
Erp
Software Documentation
Agarose Gel Electrophoresis
Glp
Sop
Hplc
Lims
Interests:
Process Validation
Continual Process Improvement
Chemical and Biological Engineering
Spc
Education
Environment
Lean and Quality Systems
Science and Technology
Quality Records
Health
Software Validation
Gmp
Arts and Culture
Erp Software
Continual Process Improvement
Chemical and Biological Engineering
Spc
Education
Environment
Lean and Quality Systems
Science and Technology
Quality Records
Health
Software Validation
Gmp
Arts and Culture
Erp Software
Languages:
English
Certifications:
Management Foundations (2013)
Strategic Planning Foundations
Leading Change
Decision-Making Strategies
Balanced Scorecard and Key Performance Indicators
Marketing Foundations
Marketing Foundations: Market Research
Marketing Foundations: Understanding Consumer Behavior
Marketing Foundations: Competitive Market Analysis
Marketing Foundations: International Marketing
Strategic Planning Foundations
Leading Change
Decision-Making Strategies
Balanced Scorecard and Key Performance Indicators
Marketing Foundations
Marketing Foundations: Market Research
Marketing Foundations: Understanding Consumer Behavior
Marketing Foundations: Competitive Market Analysis
Marketing Foundations: International Marketing
Nicholas Noli Thousand Oaks, CA
View pageWork:
Thermo-Fisher Scientific
Jan 2013 to 2000
Quality Control Associate
Thermo-Fisher Scientific
Canoga Park, CA
Sep 2010 to Jan 2013
Laboratory Associate III
Department of Biological Chemistry - University of California
Los Angeles, CA
Jun 2009 to May 2010
Volunteer Research Assistant
Jan 2013 to 2000
Quality Control Associate
Thermo-Fisher Scientific
Canoga Park, CA
Sep 2010 to Jan 2013
Laboratory Associate III
Department of Biological Chemistry - University of California
Los Angeles, CA
Jun 2009 to May 2010
Volunteer Research Assistant
Education:
University of California
Los Angeles, CA
Jun 2010
Bachelors of Science in Bioengineering
Los Angeles, CA
Jun 2010
Bachelors of Science in Bioengineering
Skills:
Lean Manufacturing (5S, Lean Sigma, Kaizen), cGMP, Supply Chain Management Basics, GDP, Technical Writing (SOPs and quality documentation), Software validation, spreadsheet validation, Method Validation, Product Surveillance, QA Inspections, Microsoft Office, Advanced Microsoft Excel (VBA), Microsoft Dynamics AX, MAS200 ERP Solutions, Visual Studio, MATLAB with Simulink, LabView, COSMOL, Bioreactor Design, Diffusional Analysis, SDS-PAGE, agarose gel electrophoresis, PCR, Western blots, immunoprecipitation, mammalian & bacterial cell culture.