cGMP Validation
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cGMP Validation Employees
Finger Lakes Institute at Hobart and William Smith Colleges March 2014 - Present
The College at Brockport August 2004 - Present
SUNY Brockport July 2004 - May 2014
The College at Brockport January 2005 - March 2014
RochesterCares Inc. January 2007 - December 2012
La Hesperia Biological Research Station 2007 - 2012
SUNY Brockport July 2004 - July 2006
The College at Brockport, SUNY January 2000 - January 2002
cGMP Validation May 2000 - August 2001
Skills
PowerPoint, Excel, Dreamweaver, Gas Chromatography, Mass Spectrometry, Higher Education, Public Speaking, Research, Seining, Grant Writing, Community Outreach, Teaching, Program Development, Environmental Awareness, Data Analysis, Water Quality, SPSS, Statistics, Microsoft Excel, Program Evaluation, Program Management, Community Development, Nonprofits, Environmental Science, Policy, Event Planning, Grants, Technical Writing, Curriculum Development, Training, Social Media, Public Relations, Curriculum Design, Student Development, Student Affairs, Ecology, Volunteer Management, Policy Analysis, Qualitative Research, Editing, Proposal Writing, Fundraising, Sustainability, Project Management, Adult Education, Critical Thinking, Staff Development
Education
Ithaca College 2011 — 2013
Professional Certificate
State University of New York College at Brockport 2007 — 2009
MPA
State University of New York College at Brockport 2002 — 2004
MSc
State University of New York College at Plattsburgh 1998 — 2000
BSc
The Founders Fund June 2011 - Present
Soshi.com May 2010 - June 2011
Bain & Company September 2007 - May 2010
Space Exploration Technologies June 2003 - September 2007
Boeing, Airborne Laser Project August 2002 - December 2002
cGMP Validation June 2001 - August 2001
Skills
Entrepreneurship, Start-ups, Venture Capital, Product Management, Financial Modeling, Strategy, Product Development, Business Strategy, Systems Engineering, Valuation, Aerospace, Management Consulting, Corporate Development, Due Diligence, Private Equity, Program Management
Education
Stanford University Graduate School of Business 2010 — 2012
MBA
Cornell University 2003 — 2004
Master of Engineering, Aerospace Engineering
Cornell University 2000 — 2003
Bachelor of Science, Mechanical Engineer
Catalent Pharma Solutions February 2012 - Present
Aptuit October 2005 - February 2012
Quintiles June 2000 - September 2005
cGMP Validation January 2000 - June 2000
Oread Inc August 1998 - January 2000
Hoechst Marion Roussel November 1981 - August 1998
Skills
CAPA, Calibration, Sop, Validation, FDA, Quality System, GMP, Program Management, Change Control, 21 CFR Part 11, Computer System..., Metrology, GLP, V&V, Software Documentation, FDA GMP, HPLC, Automation, Quality Control, Cross-functional Team..., Biopharmaceuticals, Biotechnology, Regulatory Requirements, Chemistry, Pharmaceutical Industry, GAMP, LIMS, Cleaning Validation, Chromatography, GxP, R&D, Medical Devices, Quality Assurance, Process Simulation, Regulatory Submissions, Pharmaceutics, Clinical Development, Aseptic Processing, Technology Transfer, ISO 13485, Lifesciences, Analytical Chemistry, Continuous Improvement, Manufacturing, Root Cause Analysis, Six Sigma, Quality Auditing, Lean Manufacturing, Quality Management
Education
Longview Community College 1989 — 1991
Associate of Applied Science, Electronics
Compliance Team Inc. May 2012 - May 2014
Independent Contractor March 2011 - March 2012
cGMP Validation January 2008 - November 2010
Independent Contractor December 2006 - December 2007
Performance Validation May 2003 - November 2005
L'Oreal USA May 1997 - January 2003
Skills
Validation, GMP, Quality System, V&V, Quality Assurance, CAPA, Computer System..., Engineering, FDA, ISO 13485, Inspection, Lean Manufacturing, Medical Devices, Quality Auditing, Quality Control, Root Cause Analysis, SOP, Sop, V
Education
Clemson University
Bachelor of Science (BS), Mechanical Engineering
Bodek and Rhodes March 2015 - Present
Jenzabar March 2013 - March 2015
Engility Corporation October 2007 - March 2013
PRICE Systems July 2006 - August 2007
JVN Communications 2003 - July 2006
EVS holdings February 2003 - April 2003
CGMP Validation July 2002 - February 2003
DIGINEXUS April 2001 - April 2002
Lockheed Martin October 1997 - April 2001
ITT Aerospace Communications January 1997 - September 1997
Skills
C++, Java, Linux, Perl, .NET, PL/SQL, Agile, Visual Studio, ClearCase, JavaScript, HTML, SQL Server, C, Software Development, XML, C#, ASP.NET, Windows, Unix, Requirements Analysis, SQL, AJAX, Visual Basic, CSS, PHP, SOA, MySQL, Eclipse, Solaris, Web Services, JSP, Databases, Shell Scripting, OOP, Embedded Systems, Architecture, Python, Apache, Program Management, Operating Systems, Agile Methodologies
Education
Saint Joseph's University 1992 — 2001
MS, Computer Science
Saint Joseph's University 1992 — 1996
BS, Physics
Ocean City High School 1988 — 1992
High School Diploma, College Prep
ERT October 2012 - Present
PHT Corporation February 2009 - October 2012
PHT Corporation September 2007 - February 2009
PHT Corporation March 2007 - September 2007
CSSC 2005 - 2007
Mitochondrial Disease Action Committee 2004 - 2007
cGMP Validation 2002 - 2005
Waters Corporation 1986 - 1999
Skills
Quality Management, Computer System..., ISO, Continuous Improvement, auditing, Supplier Quality, Risk Management, Compliance, Quality Assurance, Software Quality..., SDLC, Agile Methodologies, GMP, GCP, GLP, ePRO, eClinical, EDC, EHR, Process Improvement, Cross-functional Team..., Auditing, Pharmaceutical Industry, Software Documentation, e-PRO, CRO, Quality System, 21 CFR Part 11, Change Control, Clinical Trials, Program Management, Testing, Regulatory Affairs, Validation, FDA, CAPA, Sop, Clinical Data Management, Medical Devices, Clinical Research, ISO 13485, CTMS, Data Management, Clinical Development, Biotechnology, Quality Control, Lifesciences, Process Simulation, SOP
Education
Bridgewater State University 1990 — 1995
Baxalta September 2015 - Present
Nolen Orthopaedics 2010 - Present
Immucor, Inc. April 2012 - September 2015
Black Diamond Networks January 2012 - April 2012
CryoLife, Inc. June 2009 - October 2011
Altus Pharmaceuticals July 2008 - March 2009
Alkermes February 2007 - July 2008
cGMP Validation March 1997 - January 2007
CRB 1995 - 1997
Skills
Quality Control, Validation, GMP, Medical Devices, FDA, CAPA, Biotechnology, Sop, V&V, Pharmaceutical Industry, Quality Assurance, Quality System, ISO 13485, Leadership, GxP, 21 CFR Part 11, Change Control
Education
The University of Kansas 1989 — 1994
Bachelors, Mechanical Engineering
cGMP Validation Project ManagerActavis2005 - Present
Schering Plough 2003 - 2005
Cenogenics December 1996 - January 2001
Skills
Computer System..., Process Validation, Building Management..., cGMP, Validation, 21 CFR Part 11, Testing, Quality Assurance, SOP, GMP, GAMP, Technical Writing, Risk Assessment, Commissioning, Pharmaceuticals, Quality Systems, Change Control, ISO 13485, GxP, Regulatory Affairs, V&V, Quality Auditing, ISO, Aseptic Processing, Sop, Root Cause Analysis, Quality Control, Software Documentation, Pharmaceutical Industry, FDA, CAPA, LIMS, Quality System
Education
The College of New Jersey 1988 — 1992
BS, Biology
AGM Quality GMP Audits 2011 - Present
Pfizer PGM, SCBU/BioTherapeutics 2007 - 2010
Wyeth Biotech 2001 - 2007
Wyeth 1998 - 2001
cGMP Validation 1997 - 1998
Solvay Pharmaceuticals 1992 - 1997
Burroughs Wellcome 1986 - 1992
Education
Fairleigh Dickinson University
MBA, Pharnaceuticals
Marietta College
BS, Chemistry
cGMP Validation Quality Systems AnalystSchering-Plough Pharmaceuticals2003 - 2005
Education
The College of New Jersey 1988 — 1992
cGMP Validation January 2008 - Present
Pfizer 2002 - 2009
Stelex December 2006 - January 2008
Technisource June 2003 - November 2005
MetLife October 2000 - September 2001
Education
Western Michigan University - Haworth College of Business 2003 — 2005
MBA, Marketing
University of Connecticut 1997 — 2000
BS, Management Information Systems
TEKsystems July 2012 - September 2015
Ascendum Solutions April 2012 - July 2012
Paragon Consulting Services December 2009 - June 2011
TEKsystems February 2009 - September 2009
cGMP Validation December 2006 - August 2008
StaffMe.net, LLC November 2002 - April 2004
Fluor Fernald, Inc. September 1994 - April 2002
Skills
Technical Writing, Document Management, Document Imaging, Records Management, Training &..., Process Improvement, Process Development, Organizing, Soft Skills, Manual Testing, System Testing, Presentation Development, Customer Relations, SharePoint
Education
Miami University 1998 — 2006
High School, Business Management, 4.0
Greenhills High School, Greenhills, Ohio 1971 — 1975
High School, College/University Preparatory and Advanced High School/Secondary Diploma Program, 3.2
cGMP Validation Validation Team LeaderJacobs ConsultancyJune 2003 - December 2006
Education
Nazarene Seminary 1989 — 1992
Adult Education
MidAmerica Nazarene University 1988 — 1989
BA, Business Administration
cGMP Validation July 1997 - April 2006
sanofi-aventis (Marion Labs) December 1987 - 1995
Jen-Sal / Welcome / Coopers Animal Health 1971 - 1987
Skills
Validation, Commissioning, GMP, Technology Transfer, Pharmaceutical Industry, Manufacturing, Computer System..., GLP, Sop, Quality System, Biopharmaceuticals, FDA, 21 CFR Part 11, CAPA, Change Control, V&V, Biotechnology, GxP, Regulatory Affairs, LIMS, Pharmaceutics, Vaccines, Regulatory Requirements, Cleaning Validation
Education
Rockhurst University 1977 — 1981
MBA, Management
Emporia State University 1962 — 1969
BA, Biology - Microbiology and Chemistry
Kiowa High School 1958 — 1962
High School, High School
Imaging Endpoints March 2015 - Present
Octapharma Plasma, Inc. February 2014 - February 2015
PharmEng Technology August 2012 - February 2014
Pfizer (King Pharmaceuticals, Inc.) May 2004 - August 2012
cGMP Validation May 1997 - May 2004
CRB Consulting Engineers May 1993 - May 1997
Integrated Health Services May 1990 - May 1994
Peters-Eichler 1986 - 1990
Haberberger Design, Inc. (Consulting Engineers/Construction Managers) May 1984 - May 1986
Harley Gordon and Associates, Inc. May 1981 - May 1984
Skills
Demonstrated Leadership..., Project Management..., Expert FDA Regulated..., Validation, 21 CFR Part 11, GMP, FDA, LIMS, GLP, SCADA, Documentum, PLC, Quality Center, Wonderware, Building Automation, cGMP, CAPA, SOP, Computer System..., Pharmaceuticals, Change Control, Quality Assurance, Quality Systems, Process Validation, GxP, GAMP, Manufacturing, Six Sigma, Automation, Documentation, Document Management, ISO, Continuous Improvement, Compliance, Testing, Cleaning Validation, Life Sciences, Technical Writing, Quality Management, Software Validation, Commissioning, Root Cause Analysis, Quality Auditing, Project Management, Software Documentation, Quality System, V&V, GCP, Pharmaceutical Industry, Aseptic Processing
Education
University of Kansas 1976 — 1981
Bachelor of Science
Kansas State University 1979 — 1981
BS, Geography
University of Phoenix 2007 — 2009
MBA, Business