cGMP Validation

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cGMP Validation Employees

Employee
Years
Job
Industry
Hilary R. Mosher Hilary R. Mosher Geneva, New York Details
Hilary R. Mosher's cGMP Validation Experience May 2000 - August 2001
Job Coordinator, Finger Lakes Partnerships for Regional Invasive Species Management (PRISM)
Industry Higher Education
Experience
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

Scott Nolan Scott Nolan San Francisco Bay Area Details
Scott Nolan's cGMP Validation Experience June 2001 - August 2001
Job Partner at Founders Fund // Entrepreneur
Industry Venture Capital & Private Equity
Experience
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

Gus Cannon Gus Cannon Kansas City, Missouri Area Details
Gus Cannon's cGMP Validation Experience January 2000 - June 2000
Job Senior Manager, Metrology at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
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

Jon Harrison Jon Harrison Indianapolis, Indiana Area Details
Jon Harrison's cGMP Validation Experience January 2008 - November 2010
Job Senior Validation Engineering Contractor at Terumo Cardiovascular Systems
Industry Internet
Experience
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

Matt Zeits Matt Zeits Philadelphia, Pennsylvania Details
Matt Zeits's cGMP Validation Experience July 2002 - February 2003
Job Software Development Manager at Bodek and Rhodes
Industry Apparel & Fashion
Experience
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

Rod Thorell Rod Thorell Greater Boston Area Details
Rod Thorell's cGMP Validation Experience 2002 - 2005
Job Sr. Product Manager at ERT Corporation
Industry Pharmaceuticals
Experience
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

Darren Nolen, P.E. Darren Nolen, P.E. Greater Atlanta Area Details
Darren Nolen, P.E.'s cGMP Validation Experience March 1997 - January 2007
Job Buzzword Title
Industry Pharmaceuticals
Experience
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

Glen Hronich Glen Hronich Greater New York City Area Details
Glen Hronich's cGMP Validation Experience Project ManagerActavis2005 - Present
Job Project Manager at cGMP Validation
Industry Pharmaceuticals
Experience
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

Al Mason Al Mason Raleigh-Durham, North Carolina Area Details
Al Mason's cGMP Validation Experience 1997 - 1998
Job Owner at AGM Quality GMP Audits
Industry Biotechnology
Experience
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

Glen Hronich Glen Hronich Greater New York City Area Details
Glen Hronich's cGMP Validation Experience Quality Systems AnalystSchering-Plough Pharmaceuticals2003 - 2005
Job Project Manager at cGMP Validation
Industry Pharmaceuticals
Experience
cGMP Validation   Quality Systems AnalystSchering-Plough Pharmaceuticals2003 - 2005

Education
The College of New Jersey   1988 — 1992

Heather Krieg Heather Krieg Kalamazoo, Michigan Area Details
Heather Krieg's cGMP Validation Experience January 2008 - Present
Job Validation Engineer at cGMP Validation
Industry Pharmaceuticals
Experience
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

Anne Hawley Anne Hawley Cincinnati Area Details
Anne Hawley's cGMP Validation Experience December 2006 - August 2008
Job Contract Technical Writer at TEKsystems
Industry Computer Software
Experience
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

Tim Melton Tim Melton Dalton, Nebraska Details
Tim Melton's cGMP Validation Experience Validation Team LeaderJacobs ConsultancyJune 2003 - December 2006
Job Team Leader / Validation Specialist at cGMP Validation
Industry Pharmaceuticals
Experience
cGMP Validation   Validation Team LeaderJacobs ConsultancyJune 2003 - December 2006

Education
Nazarene Seminary   1989 — 1992
Adult Education

MidAmerica Nazarene University   1988 — 1989
BA, Business Administration

Bob Stranathan Bob Stranathan Kansas City, Missouri Area Details
Bob Stranathan's cGMP Validation Experience July 1997 - April 2006
Job Independent Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
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

Craig C Bryant, MBA Craig C Bryant, MBA Scottsdale, Arizona Details
Craig C Bryant, MBA's cGMP Validation Experience May 1997 - May 2004
Job Senior Validation Consultant at Imaging Endpoints
Industry Pharmaceuticals
Experience
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