US Data Management
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US Data Management Employees
Employee
Years
Job
Industry
Cris Cazor Cris Cazor's US Data Management Experience 2011 - 2011
Job Filmmaker | Editor
Industry Motion Pictures and Film
Experience
CFSSB August 2012 - April 2013
Conception Media Group 2012 - 2013
Rebecca Brand Productions May 2011 - August 2012
US Data Management 2011 - 2011
adidas 2011 - 2011
Atomica S.A. May 2007 - April 2010
Altiro Comunicaciones 2010 - 2010
DPIP Capacitación en Desarrollo Profesional e Imagen Personal Ltda. 2002 - 2010
Skills
Videography, Film Editing, Film Production, Feature Films, Film, Short Films, Action Sports, Camera Operating, HD Video, Music Videos, Corporate Communications, Web Video, Social Media, Teaching, Camera Operation, Editing, Photography, Video
Education
Universidad de Artes, Ciencias y Comunicación 1997 — 2002
Bachelor of Arts (B.A.), Cinematography and Film/Video Production
CFSSB August 2012 - April 2013
Conception Media Group 2012 - 2013
Rebecca Brand Productions May 2011 - August 2012
US Data Management 2011 - 2011
adidas 2011 - 2011
Atomica S.A. May 2007 - April 2010
Altiro Comunicaciones 2010 - 2010
DPIP Capacitación en Desarrollo Profesional e Imagen Personal Ltda. 2002 - 2010
Skills
Videography, Film Editing, Film Production, Feature Films, Film, Short Films, Action Sports, Camera Operating, HD Video, Music Videos, Corporate Communications, Web Video, Social Media, Teaching, Camera Operation, Editing, Photography, Video
Education
Universidad de Artes, Ciencias y Comunicación 1997 — 2002
Bachelor of Arts (B.A.), Cinematography and Film/Video Production
David Hawes David Hawes's US Data Management Experience April 2012 - May 2014
Job Validation Engineer CSV at Ajinomoto Althea, Inc.
Industry Computer Software
Experience
Ajinomoto Althea, Inc. May 2014 - Present
US Data Management April 2012 - May 2014
Teva Pharmaceuticals January 2002 - December 2011
Sicor September 2000 - January 2002
Mitsubishi Digital Electronics November 1996 - February 2000
Skills
Computer System..., 21 CFR Part 11, Change Control, GMP, Oracle Applications, Validation, BPCS, Sop, Oracle Discoverer, Pharmaceutical Industry, Software Documentation, GAMP, GxP, Quality Assurance, ERP, OS/400, Business Analysis, CAPA, LIMS, Regulatory Requirements, Oracle E-Business Suite, Software Quality..., Change Management, FDA, Oracle, Business Intelligence, SAP, V&V, Compliance, FDA GMP, Requirements Analysis, RPG III, IBM iSeries, Manufacturing, SDLC, Quality Auditing, HP ALM, User Acceptance Testing, Test Planning, System Testing, Requirement..., Enterprise Software, Microsoft Office, Functional..., Test Scripts, MRP, Software Verification, Test Validation, Quality Center, ERP Oracle
Education
Coventry University 1979 — 1981
HND, Computer Studies
Broadoak Comprehensive 1973 — 1979
Weston-super-Mare, England
Ajinomoto Althea, Inc. May 2014 - Present
US Data Management April 2012 - May 2014
Teva Pharmaceuticals January 2002 - December 2011
Sicor September 2000 - January 2002
Mitsubishi Digital Electronics November 1996 - February 2000
Skills
Computer System..., 21 CFR Part 11, Change Control, GMP, Oracle Applications, Validation, BPCS, Sop, Oracle Discoverer, Pharmaceutical Industry, Software Documentation, GAMP, GxP, Quality Assurance, ERP, OS/400, Business Analysis, CAPA, LIMS, Regulatory Requirements, Oracle E-Business Suite, Software Quality..., Change Management, FDA, Oracle, Business Intelligence, SAP, V&V, Compliance, FDA GMP, Requirements Analysis, RPG III, IBM iSeries, Manufacturing, SDLC, Quality Auditing, HP ALM, User Acceptance Testing, Test Planning, System Testing, Requirement..., Enterprise Software, Microsoft Office, Functional..., Test Scripts, MRP, Software Verification, Test Validation, Quality Center, ERP Oracle
Education
Coventry University 1979 — 1981
HND, Computer Studies
Broadoak Comprehensive 1973 — 1979
Weston-super-Mare, England
Susan Justice Susan Justice's US Data Management Experience January 2009 - November 2010
Job Quality Engineer at Ethicon via Alku International
Industry Pharmaceuticals
Experience
ETHICON Johnson & Johnson June 2015 - Present
Thermofisher Scientific November 2014 - March 2015
Baxter Healthcare via USDM October 2011 - December 2013
Leica Microsystems January 2011 - June 2011
Regulatory Compliance Associates, Inc. August 2010 - January 2011
US Data Management January 2009 - November 2010
US Data Management November 2009 - May 2010
2009 - 2009 Validant Consulting November 2009 - May 2010
Validant July 2009 - October 2009
Cardinal Health May 2006 - August 2008
Skills
CAPA, FDA, V&V, Quality System, Software Documentation, Root Cause Analysis, 21 CFR Part 11, Validation, GMP, Change Control, Sop, Pharmaceutical Industry, Biotechnology, Calibration, Computer System..., Cross-functional Team..., Design Control, FMEA, GLP, GxP, Hardware Diagnostics, ISO, ISO 13485, LIMS, Lifesciences, Manufacturing, Medical Devices, Pharmaceutics, Process Improvement, Quality Assurance, Quality Auditing, Quality Control, Regulatory Affairs, Regulatory Requirements, Six Sigma, Technical Writing, Testing, Trackwise, Documentation, Training, Continuous Improvement, Document Management
Education
Illinois State University 1993 — 1995
Bachelor, Biology
in Medical Laboratory Technology @ CLC 1993 — 1995
Bachelor of ScienceAssociate of Applied Science, Biology @ ISU
ETHICON Johnson & Johnson June 2015 - Present
Thermofisher Scientific November 2014 - March 2015
Baxter Healthcare via USDM October 2011 - December 2013
Leica Microsystems January 2011 - June 2011
Regulatory Compliance Associates, Inc. August 2010 - January 2011
US Data Management January 2009 - November 2010
US Data Management November 2009 - May 2010
2009 - 2009 Validant Consulting November 2009 - May 2010
Validant July 2009 - October 2009
Cardinal Health May 2006 - August 2008
Skills
CAPA, FDA, V&V, Quality System, Software Documentation, Root Cause Analysis, 21 CFR Part 11, Validation, GMP, Change Control, Sop, Pharmaceutical Industry, Biotechnology, Calibration, Computer System..., Cross-functional Team..., Design Control, FMEA, GLP, GxP, Hardware Diagnostics, ISO, ISO 13485, LIMS, Lifesciences, Manufacturing, Medical Devices, Pharmaceutics, Process Improvement, Quality Assurance, Quality Auditing, Quality Control, Regulatory Affairs, Regulatory Requirements, Six Sigma, Technical Writing, Testing, Trackwise, Documentation, Training, Continuous Improvement, Document Management
Education
Illinois State University 1993 — 1995
Bachelor, Biology
in Medical Laboratory Technology @ CLC 1993 — 1995
Bachelor of ScienceAssociate of Applied Science, Biology @ ISU
Jennifer Cook Jennifer Cook's US Data Management Experience February 2012 - October 2012
Job Talent Acquistion/Sourcing Specialist at Valeant Pharmaceuticals
Industry Pharmaceuticals
Experience
Valeant Pharmaceuticals November 2014 - Present
Valeant Pharmaceuticals 2014 - 2015
Valeant Pharmaceuticals 2014 - 2015
Valeant Pharmaceuticals 2014 - 2015
Kelly Services October 2012 - September 2014
Valeant Pharmaceuticals 2014 - 2014
US Data Management February 2012 - October 2012
Kelly Services June 2011 - February 2012
Pharmaceutical Clinical Associates, LLC (acquired by Mindlance 1/2010) April 2004 - September 2010
Lab Support, a division of On Assignment September 2001 - April 2004
Skills
Recruitment, Business Development, Personnel Management, Pharmaceuticals, Strategic Sourcing, Boolean Searching, Social Networking, Full life cycle..., Strategic Negotiations, Clinical Research, Scientific, Engineering, Regulatory Affairs, R&D, post market, Drug Safety, GxP, Pharmaceutical Industry, Compliance, Recruiting, Consulting, Quality Assurance, Interviews, Validation, GCP, Staffing Services, Temporary Staffing, Project Management, CRO, Biotechnology, Technical Recruiting, 21 CFR Part 11, Leadership, Clinical Trials, Temporary Placement, FDA, Sop, SOP
Education
University of Medicine and Dentistry of New Jersey 2001 — 2002
MS, Biomedical Informatics
City University of New York-College of Staten Island 1995 — 2001
BS, Biology/Bioinformatics
Montclair State University 1988 — 1991
Montclair State University 1988 — 1990
Montclair State University
Valeant Pharmaceuticals November 2014 - Present
Valeant Pharmaceuticals 2014 - 2015
Valeant Pharmaceuticals 2014 - 2015
Valeant Pharmaceuticals 2014 - 2015
Kelly Services October 2012 - September 2014
Valeant Pharmaceuticals 2014 - 2014
US Data Management February 2012 - October 2012
Kelly Services June 2011 - February 2012
Pharmaceutical Clinical Associates, LLC (acquired by Mindlance 1/2010) April 2004 - September 2010
Lab Support, a division of On Assignment September 2001 - April 2004
Skills
Recruitment, Business Development, Personnel Management, Pharmaceuticals, Strategic Sourcing, Boolean Searching, Social Networking, Full life cycle..., Strategic Negotiations, Clinical Research, Scientific, Engineering, Regulatory Affairs, R&D, post market, Drug Safety, GxP, Pharmaceutical Industry, Compliance, Recruiting, Consulting, Quality Assurance, Interviews, Validation, GCP, Staffing Services, Temporary Staffing, Project Management, CRO, Biotechnology, Technical Recruiting, 21 CFR Part 11, Leadership, Clinical Trials, Temporary Placement, FDA, Sop, SOP
Education
University of Medicine and Dentistry of New Jersey 2001 — 2002
MS, Biomedical Informatics
City University of New York-College of Staten Island 1995 — 2001
BS, Biology/Bioinformatics
Montclair State University 1988 — 1991
Montclair State University 1988 — 1990
Montclair State University
Charles Collier Charles Collier's US Data Management Experience 2009 - April 2012
Job IT PM, CSV, and QA Professional
Industry Information Technology and Services
Experience
Gilead Sciences March 2014 - Present
Onyx Pharmaceuticals May 2013 - March 2014
Abbott Diabetes Care August 2012 - December 2012
US Data Management 2009 - April 2012
IT&E International September 2007 - November 2008
Washington Group International 2005 - 2006
PAREXEL Consulting 2001 - 2005
Skills
GxP, Computer System..., 21 CFR Part 11, Quality Auditing, Validation, Regulatory Affairs, FDA, Medical Devices, V&V, Sop, Quality Assurance, Project Management, Change Control, SDLC, Quality System, Requirements Analysis, CAPA, GMP, Information Technology, R&D, Pharmaceutical Industry, Project Planning, GAMP, Biotechnology, Lifesciences, ISO 13485, GLP, Technology Transfer, SOP, Life Sciences
Education
United States Naval Academy 1967 — 1971
B.S, Physics
US Naval Nuclear Power Schools
Gilead Sciences March 2014 - Present
Onyx Pharmaceuticals May 2013 - March 2014
Abbott Diabetes Care August 2012 - December 2012
US Data Management 2009 - April 2012
IT&E International September 2007 - November 2008
Washington Group International 2005 - 2006
PAREXEL Consulting 2001 - 2005
Skills
GxP, Computer System..., 21 CFR Part 11, Quality Auditing, Validation, Regulatory Affairs, FDA, Medical Devices, V&V, Sop, Quality Assurance, Project Management, Change Control, SDLC, Quality System, Requirements Analysis, CAPA, GMP, Information Technology, R&D, Pharmaceutical Industry, Project Planning, GAMP, Biotechnology, Lifesciences, ISO 13485, GLP, Technology Transfer, SOP, Life Sciences
Education
United States Naval Academy 1967 — 1971
B.S, Physics
US Naval Nuclear Power Schools
Jim Kerr's US Data Management Experience January 2011 - April 2012
Job Sr. Supply Chain and Manufacturing Systems Architect and Program Manager
Industry Information Technology and Services
Experience
Siemens Healthcare Diagnostics and Instruments via ALKU Technologies July 2015 - Present
ARRIS Inc via TEKsystems July 2013 - July 2015
USDM November 2010 - May 2013
US Data Management January 2011 - April 2012
Teva Pharmaceuticals USA July 2008 - November 2010
Business & Decision 2005 - 2008
Mi-Services Group 2001 - 2005
Hesta Corporation July 1998 - February 2001
Skills
Supply Chain, Operations Management, Oracle Applications, Procurement, Inventory Management, ERP, Lifesciences, Oracle HR, Quality Assurance, Microsoft Dynamics AX, SAP ECC 6.0, SAP ME, Manufacturing Execution..., JDEdwards Enterprise One, Oracle E-Business Suite, Large Scale Deployments, Electronic Production..., Product Serialization, Medical Devices, Pharmaceutical Industry, Biotechnology, MES, Oracle Agile PLM, Computer System..., 21 CFR Part 11, 21 CFR Part 820, 21 CFR Part 210 & 211, HP Quality Center v11.0, HP Quick Test Pro, Genilogix eApprove, Oracle Learning..., Discrete Manufacturing, Process Manufacturing, Pharmaceutical Packaging, Unique Device..., Oracle UPK, Oracle Tutor, GAMP5, Oracle AIM, SAP ASAP, Oracle Unified Method, PMBOK, Salesforce.com, LabWare, Trackwise, Siemens Teamcenter, Oracle E-Records, Oracle OPSM, Organizational..., ISO 13485
Education
University of Notre Dame - Mendoza College of Business 1996 — 1997
MBA, Manufacturing Management
Georgetown University 1988 — 1992
BSBA, Finance
Holy Cross High School, Flushing, NY 1984 — 1998
Siemens Healthcare Diagnostics and Instruments via ALKU Technologies July 2015 - Present
ARRIS Inc via TEKsystems July 2013 - July 2015
USDM November 2010 - May 2013
US Data Management January 2011 - April 2012
Teva Pharmaceuticals USA July 2008 - November 2010
Business & Decision 2005 - 2008
Mi-Services Group 2001 - 2005
Hesta Corporation July 1998 - February 2001
Skills
Supply Chain, Operations Management, Oracle Applications, Procurement, Inventory Management, ERP, Lifesciences, Oracle HR, Quality Assurance, Microsoft Dynamics AX, SAP ECC 6.0, SAP ME, Manufacturing Execution..., JDEdwards Enterprise One, Oracle E-Business Suite, Large Scale Deployments, Electronic Production..., Product Serialization, Medical Devices, Pharmaceutical Industry, Biotechnology, MES, Oracle Agile PLM, Computer System..., 21 CFR Part 11, 21 CFR Part 820, 21 CFR Part 210 & 211, HP Quality Center v11.0, HP Quick Test Pro, Genilogix eApprove, Oracle Learning..., Discrete Manufacturing, Process Manufacturing, Pharmaceutical Packaging, Unique Device..., Oracle UPK, Oracle Tutor, GAMP5, Oracle AIM, SAP ASAP, Oracle Unified Method, PMBOK, Salesforce.com, LabWare, Trackwise, Siemens Teamcenter, Oracle E-Records, Oracle OPSM, Organizational..., ISO 13485
Education
University of Notre Dame - Mendoza College of Business 1996 — 1997
MBA, Manufacturing Management
Georgetown University 1988 — 1992
BSBA, Finance
Holy Cross High School, Flushing, NY 1984 — 1998
Peter Lodenquai Peter Lodenquai's US Data Management Experience March 2015 - Present
Job Consultant/Training Support Specialist with US Data Management Life Sciences
Industry Pharmaceuticals
Experience
US Data Management March 2015 - Present
Instructional Design Analytics January 2015 - Present
Pacific Biosciences October 2012 - June 2014
AB SCIEX September 2007 - September 2012
Applied Biosystems July 2005 - August 2007
Millenium Pharmaceuticals September 2001 - June 2005
Genentech, Inc. July 1993 - August 2001
Hybritech Incorporated November 1989 - July 1993
Skills
Mass Spectrometry, Life Sciences, Laboratory, HPLC, Technical Training, Biotechnology, LIMS, Pharmaceutical Industry, Technology Transfer, Lifesciences, E-Learning, eLearning Development, FDA, Product Launch, Biopharmaceuticals, LC-MS, Validation, Drug Discovery, Chromatography, GLP, Technical Writing, Laboratory Research, Instructional Design, Diagnostics, Analytical Method..., GLP - Good Laboratory..., cGMP- current Good..., emodule development-..., Analytical Method..., Bioanalytical, Global Customer Service, Instructor Led Training..., Storyboarding, Digital Photography, Curriculum Development, Articulate Storyline 2, Analytical Chemistry, Chemistry, Biochemistry, GMP, R&D
Education
University of California, San Diego 1987 — 1993
Bachelor of Science, Biology
US Data Management March 2015 - Present
Instructional Design Analytics January 2015 - Present
Pacific Biosciences October 2012 - June 2014
AB SCIEX September 2007 - September 2012
Applied Biosystems July 2005 - August 2007
Millenium Pharmaceuticals September 2001 - June 2005
Genentech, Inc. July 1993 - August 2001
Hybritech Incorporated November 1989 - July 1993
Skills
Mass Spectrometry, Life Sciences, Laboratory, HPLC, Technical Training, Biotechnology, LIMS, Pharmaceutical Industry, Technology Transfer, Lifesciences, E-Learning, eLearning Development, FDA, Product Launch, Biopharmaceuticals, LC-MS, Validation, Drug Discovery, Chromatography, GLP, Technical Writing, Laboratory Research, Instructional Design, Diagnostics, Analytical Method..., GLP - Good Laboratory..., cGMP- current Good..., emodule development-..., Analytical Method..., Bioanalytical, Global Customer Service, Instructor Led Training..., Storyboarding, Digital Photography, Curriculum Development, Articulate Storyline 2, Analytical Chemistry, Chemistry, Biochemistry, GMP, R&D
Education
University of California, San Diego 1987 — 1993
Bachelor of Science, Biology
Mary Fetherolf's US Data Management Experience May 2011 - July 2011
Job IT Program Management/PPM/Big Data
Industry Information Technology and Services
Experience
Genentech June 2014 - June 2015
Abbott January 2013 - March 2014
Kaiser Permanente IT January 2012 - November 2012
US Data Management May 2011 - July 2011
Oak Street Associates, Inc. February 2007 - April 2011
Kaiser Permanente IT December 2010 - March 2011
Thoratec September 2009 - December 2010
Port of Oakland March 2008 - July 2009
Novartis Vaccines and Diagnostics September 2006 - July 2008
Kaiser Permanente IT/SOX December 2005 - September 2006
Skills
Project Management, Program Management, IT Strategy, Pharmaceutical Industry, IT Management, Quality Assurance, GxP, Validation, Software Documentation, Vendor Management, Contract Negotiation, Vendor Contracts, Third Party Vendor..., SDLC, Strategy, Governance, Strategic Planning, SaaS, Change Management, Integration, Clarity, MS Project, Leadership, Consulting, ITIL, ITIL Certified, PMP, PMO, Performance Dashboards, Project Governance, PCI DSS, SOX Compliancy, Enterprise Software, Medical Devices, Business Process..., Life Science Industry, Healthcare Industry, FDA, Standard for Exchange..., Business Analysis, Management, Cross-functional Team..., Business Intelligence, Business Process, Process Improvement, Requirements Analysis, Information Technology, Project Portfolio...
Education
University of San Francisco
BS, Information Systems Management, Information Systems Management
Genentech June 2014 - June 2015
Abbott January 2013 - March 2014
Kaiser Permanente IT January 2012 - November 2012
US Data Management May 2011 - July 2011
Oak Street Associates, Inc. February 2007 - April 2011
Kaiser Permanente IT December 2010 - March 2011
Thoratec September 2009 - December 2010
Port of Oakland March 2008 - July 2009
Novartis Vaccines and Diagnostics September 2006 - July 2008
Kaiser Permanente IT/SOX December 2005 - September 2006
Skills
Project Management, Program Management, IT Strategy, Pharmaceutical Industry, IT Management, Quality Assurance, GxP, Validation, Software Documentation, Vendor Management, Contract Negotiation, Vendor Contracts, Third Party Vendor..., SDLC, Strategy, Governance, Strategic Planning, SaaS, Change Management, Integration, Clarity, MS Project, Leadership, Consulting, ITIL, ITIL Certified, PMP, PMO, Performance Dashboards, Project Governance, PCI DSS, SOX Compliancy, Enterprise Software, Medical Devices, Business Process..., Life Science Industry, Healthcare Industry, FDA, Standard for Exchange..., Business Analysis, Management, Cross-functional Team..., Business Intelligence, Business Process, Process Improvement, Requirements Analysis, Information Technology, Project Portfolio...
Education
University of San Francisco
BS, Information Systems Management, Information Systems Management
Larry Isacson Larry Isacson's US Data Management Experience August 2011 - Present
Job Practice Leader at US Data Management
Industry Pharmaceuticals
Experience
US Data Management August 2011 - Present
Arbour Group LLC January 2010 - July 2011
Intertek Pharmaceutical Services January 2009 - July 2009
Artes Medical January 2008 - December 2008
Gilead Sciences April 2001 - April 2007
MDS Pharma Services 1998 - 2001
Wawa Inc 1991 - 1998
ICI Pharmaceuticals 1984 - 1991
Skills
Computer System..., Risk Assessment, Validation, Lifesciences, ERP, GxP, IT Management, SDLC, Program Management, Pharmaceutical Industry, CAPA, Integration, Strategy, Sop, Biotechnology, Regulatory Requirements, 21 CFR Part 11, Cross-functional Team..., Management, CRM, CTMS, GCP, Medical Devices, FDA, Pharmaceutics, LIMS, Quality Assurance
Education
University of Arizona 1975 — 1977
M. S., Pharmacology and Toxicology
US Data Management August 2011 - Present
Arbour Group LLC January 2010 - July 2011
Intertek Pharmaceutical Services January 2009 - July 2009
Artes Medical January 2008 - December 2008
Gilead Sciences April 2001 - April 2007
MDS Pharma Services 1998 - 2001
Wawa Inc 1991 - 1998
ICI Pharmaceuticals 1984 - 1991
Skills
Computer System..., Risk Assessment, Validation, Lifesciences, ERP, GxP, IT Management, SDLC, Program Management, Pharmaceutical Industry, CAPA, Integration, Strategy, Sop, Biotechnology, Regulatory Requirements, 21 CFR Part 11, Cross-functional Team..., Management, CRM, CTMS, GCP, Medical Devices, FDA, Pharmaceutics, LIMS, Quality Assurance
Education
University of Arizona 1975 — 1977
M. S., Pharmacology and Toxicology
Michael Zesiger Michael Zesiger's US Data Management Experience August 2009 - December 2011
Job Senior Validation Engineer at Genentech
Industry Biotechnology
Experience
Genentech December 2011 - Present
Gilead Sciences September 2010 - December 2011
US Data Management August 2009 - December 2011
Arbour Group 2004 - 2007
Paramount's Great America 2001 - 2004
Calico Commerce 1998 - 2001
LifeScan (A J&J Company) 1996 - 1998
Volt Delta Resources 1984 - 1996
Skills
Computer System..., Project Management, Quality Assurance, GxP, SDLC, 21 CFR Part 11, Change Control, Software Documentation, Validation, FDA, Recruiting, GMP, Information Technology, Quality System, CAPA, Sop, V&V, GAMP, LIMS, Biotechnology, Medical Devices
Education
Embry-Riddle Aeronautical University 1994 — 1996
Masters, Management
California State University-Long Beach 1978 — 1981
Genentech December 2011 - Present
Gilead Sciences September 2010 - December 2011
US Data Management August 2009 - December 2011
Arbour Group 2004 - 2007
Paramount's Great America 2001 - 2004
Calico Commerce 1998 - 2001
LifeScan (A J&J Company) 1996 - 1998
Volt Delta Resources 1984 - 1996
Skills
Computer System..., Project Management, Quality Assurance, GxP, SDLC, 21 CFR Part 11, Change Control, Software Documentation, Validation, FDA, Recruiting, GMP, Information Technology, Quality System, CAPA, Sop, V&V, GAMP, LIMS, Biotechnology, Medical Devices
Education
Embry-Riddle Aeronautical University 1994 — 1996
Masters, Management
California State University-Long Beach 1978 — 1981
Farrukh Moin Farrukh Moin's US Data Management Experience May 2013 - August 2013
Job Programer Analyst at Raawee
Industry Information Technology and Services
Experience
Raawee Inc January 2012 - Present
US Data Management May 2013 - August 2013
Merck & Co, Inc March 2010 - June 2013
Barclays Capital November 2009 - February 2010
KPMG Tax & Legal Services June 2008 - October 2009
Net Prosys August 2006 - December 2007
Naveena Industries April 2001 - July 2006
Skills
SharePoint, C#, .NET, ASP.NET, Agile Methodologies, SDLC, WCF, Microsoft SQL Server, Requirements Analysis, Microsoft Office..., Architecture, SharePoint Designer, JavaScript, Integration, AJAX, Requirements Gathering, jQuery, CSS, Testing, SharePoint Server
Education
Shaheed Zulfikar Ali Bhutto Institute of Science and Technology 2001 — 2003
MCS, Software Engineer
Raawee Inc January 2012 - Present
US Data Management May 2013 - August 2013
Merck & Co, Inc March 2010 - June 2013
Barclays Capital November 2009 - February 2010
KPMG Tax & Legal Services June 2008 - October 2009
Net Prosys August 2006 - December 2007
Naveena Industries April 2001 - July 2006
Skills
SharePoint, C#, .NET, ASP.NET, Agile Methodologies, SDLC, WCF, Microsoft SQL Server, Requirements Analysis, Microsoft Office..., Architecture, SharePoint Designer, JavaScript, Integration, AJAX, Requirements Gathering, jQuery, CSS, Testing, SharePoint Server
Education
Shaheed Zulfikar Ali Bhutto Institute of Science and Technology 2001 — 2003
MCS, Software Engineer
Bob Lesnefsky Bob Lesnefsky's US Data Management Experience July 2009 - Present
Job Senior VP, Global Regulatory Compliance, Quality Assurance & Auditing
Industry Pharmaceuticals
Experience
US Data Management July 2009 - Present
Fisher December 2005 - June 2009
Bearing Point, Inc February 2004 - December 2005
CimQuest December 1997 - January 2004
Philadelphia Gear October 1995 - December 1997
Philadelphia Electric Corp. September 1987 - September 1995
United Engineers & Constructors August 1975 - July 1987
Skills
FDA, Quality Assurance, GMP, Quality System, Validation, PMP, 21 CFR Part 11, Pharmaceutical Industry, Cross-functional Team..., Computer System..., Quality Management, CAPA, Process Improvement, ISO 13485, GxP, ASQ CQA, PMI PMP, ASQ CQM, ISO14971, ICH Q9, Data Privacy/Security, ISO27000, Cloud..., Enterprise IT..., European Medical Device..., BSE/TSE, Gamma & Ethylene Oxide..., ISO14644, Software-as-a-Service..., GAMP-5, Pre-Approval Inspection..., DEA Controlled..., Risk Evaluation &..., Cetrified Manager of..., Regulatory Requirements, Sop, ISO 14971, Regulatory Submissions, Quality Control, Medical Devices, Regulatory Affairs, Pharmaceutics, GLP, Quality Auditing, ISO 27000, Biotechnology, Document Management, Testing, GCP, GAMP
Education
Rutgers University 1976 — 1981
BS, Management
Johnson Institure of Technology 1969 — 1972
AS, Mechanical Technology
US Data Management July 2009 - Present
Fisher December 2005 - June 2009
Bearing Point, Inc February 2004 - December 2005
CimQuest December 1997 - January 2004
Philadelphia Gear October 1995 - December 1997
Philadelphia Electric Corp. September 1987 - September 1995
United Engineers & Constructors August 1975 - July 1987
Skills
FDA, Quality Assurance, GMP, Quality System, Validation, PMP, 21 CFR Part 11, Pharmaceutical Industry, Cross-functional Team..., Computer System..., Quality Management, CAPA, Process Improvement, ISO 13485, GxP, ASQ CQA, PMI PMP, ASQ CQM, ISO14971, ICH Q9, Data Privacy/Security, ISO27000, Cloud..., Enterprise IT..., European Medical Device..., BSE/TSE, Gamma & Ethylene Oxide..., ISO14644, Software-as-a-Service..., GAMP-5, Pre-Approval Inspection..., DEA Controlled..., Risk Evaluation &..., Cetrified Manager of..., Regulatory Requirements, Sop, ISO 14971, Regulatory Submissions, Quality Control, Medical Devices, Regulatory Affairs, Pharmaceutics, GLP, Quality Auditing, ISO 27000, Biotechnology, Document Management, Testing, GCP, GAMP
Education
Rutgers University 1976 — 1981
BS, Management
Johnson Institure of Technology 1969 — 1972
AS, Mechanical Technology
Warren Butcher Warren Butcher's US Data Management Experience February 2012 - July 2012
Job Manager at Self EmployedConsultant, Configuration and Product Lifecycle Mgt
Industry Electrical/Electronic Manufacturing
Experience
Cymer October 2012 - June 2014
US Data Management February 2012 - July 2012
Illumina April 2008 - October 2011
Eastman Kodak 2005 - 2008
Broadband Innovations 2000 - 2004
TV/COM 1994 - 1998
Phoenix International 1988 - 1990
Skills
Configuration Management, Document Control, Agile PLM System..., Process Improvement, Document Management, System Administration, Business Analysis, Software Documentation, Cross-functional Team..., Quality Assurance, Software Project..., Program Management, Agile Methodologies, Business Process, Validation, Change Control, Integration, FDA, MS Project, Quality Management, GMP, Medical Devices, ISO 13485, ISO, Manufacturing, Testing, Training, Access, Visio, Product Lifecycle..., ERP, Process Engineering, Technical Writing
Education
UCLA
BA, History
Cymer October 2012 - June 2014
US Data Management February 2012 - July 2012
Illumina April 2008 - October 2011
Eastman Kodak 2005 - 2008
Broadband Innovations 2000 - 2004
TV/COM 1994 - 1998
Phoenix International 1988 - 1990
Skills
Configuration Management, Document Control, Agile PLM System..., Process Improvement, Document Management, System Administration, Business Analysis, Software Documentation, Cross-functional Team..., Quality Assurance, Software Project..., Program Management, Agile Methodologies, Business Process, Validation, Change Control, Integration, FDA, MS Project, Quality Management, GMP, Medical Devices, ISO 13485, ISO, Manufacturing, Testing, Training, Access, Visio, Product Lifecycle..., ERP, Process Engineering, Technical Writing
Education
UCLA
BA, History
Subbu Viswanathan's US Data Management Experience February 2009 - July 2015
Job VP, Staff Operations at USDM Life Sciences
Industry Pharmaceuticals
Experience
USDM Life Sciences July 2015 - Present
US Data Management February 2009 - July 2015
UCLA Anderson School of Management December 2012 - July 2013
Valimation January 1998 - August 2008
Skills
GAMP, Validation, FDA, Quality System, Risk Management, GMP, Quality Assurance, Computer System..., Change Control, 21 CFR Part 11, Six Sigma, Quality Auditing, Pharmaceutical Industry, Strategy, GLP, V&V, CAPA, Quality Control, Sop, SharePoint, Irony, GxP, Puns, ISO 13485, Regulatory Requirements, Manufacturing, LIMS, Medical Devices, Regulatory Affairs, Document Management, Biotechnology, Cross-functional Team..., Technology Transfer, R&D, Pharmaceutics, Lifesciences, Biopharmaceuticals, Quality Management, Process Simulation, Enterprise Software, SOP, Life Sciences
Education
UCLA Anderson School of Management 2011 — 2013
MBA, Strategy, Marketing, Dean's Honor Society
Bangalore University 1992 — 1997
BE, Mechanical Engineering, Degree Awarded with Distinction
SJBHS
USDM Life Sciences July 2015 - Present
US Data Management February 2009 - July 2015
UCLA Anderson School of Management December 2012 - July 2013
Valimation January 1998 - August 2008
Skills
GAMP, Validation, FDA, Quality System, Risk Management, GMP, Quality Assurance, Computer System..., Change Control, 21 CFR Part 11, Six Sigma, Quality Auditing, Pharmaceutical Industry, Strategy, GLP, V&V, CAPA, Quality Control, Sop, SharePoint, Irony, GxP, Puns, ISO 13485, Regulatory Requirements, Manufacturing, LIMS, Medical Devices, Regulatory Affairs, Document Management, Biotechnology, Cross-functional Team..., Technology Transfer, R&D, Pharmaceutics, Lifesciences, Biopharmaceuticals, Quality Management, Process Simulation, Enterprise Software, SOP, Life Sciences
Education
UCLA Anderson School of Management 2011 — 2013
MBA, Strategy, Marketing, Dean's Honor Society
Bangalore University 1992 — 1997
BE, Mechanical Engineering, Degree Awarded with Distinction
SJBHS
Matthew Bodo's US Data Management Experience 2002 - 2003
Job
Industry Pharmaceuticals
Experience
USDM Life Sciences October 2014 - Present
Allergan October 2013 - November 2014
Allergan Medical October 2010 - October 2013
Allergan 2007 - 2010
Watson Pharmaceuticals (Now A̶c̶t̶a̶v̶i̶s̶ Allergan) November 2003 - September 2007
US Data Management 2002 - 2003
Sun Microsystems, Inc 2000 - 2002
Agouron 1999 - 2000
USMC 1994 - 1999
Fidelity National Title June 1993 - November 1994
Skills
Quality Assurance, Computer System..., Cross-functional Team..., Validation, FDA, SDLC, Pharmaceutical Industry, Medical Devices, Testing, Change Control, GAMP, 21 CFR Part 11, GMP, GxP, Program Management, Software Documentation, Management, CAPA, Project Management, R&D, Quality System, Vendor Management, Business Strategy, ERP, Regulatory Submissions, Strategic Planning, Risk Management, Strategy, Business Analysis, LIMS, GLP, Regulatory Requirements, Compliance, Healthcare, Biotechnology, Document Management, Leadership, Business Relationship..., Business Process Mapping, Automation, Electronic Lab Notebooks, System Deployment, IT Management, IT Strategy, Data Center Relocation, Cloud Computing, Enterprise Software, People Management
Education
Arizona State University, W. P. Carey School of Business 2013 — 2014
Master of Science (MS), Information Management, 4.0 / 4.0
Pepperdine University, The George L. Graziadio School of Business and Management 2006 — 2008
BS, Management
USDM Life Sciences October 2014 - Present
Allergan October 2013 - November 2014
Allergan Medical October 2010 - October 2013
Allergan 2007 - 2010
Watson Pharmaceuticals (Now A̶c̶t̶a̶v̶i̶s̶ Allergan) November 2003 - September 2007
US Data Management 2002 - 2003
Sun Microsystems, Inc 2000 - 2002
Agouron 1999 - 2000
USMC 1994 - 1999
Fidelity National Title June 1993 - November 1994
Skills
Quality Assurance, Computer System..., Cross-functional Team..., Validation, FDA, SDLC, Pharmaceutical Industry, Medical Devices, Testing, Change Control, GAMP, 21 CFR Part 11, GMP, GxP, Program Management, Software Documentation, Management, CAPA, Project Management, R&D, Quality System, Vendor Management, Business Strategy, ERP, Regulatory Submissions, Strategic Planning, Risk Management, Strategy, Business Analysis, LIMS, GLP, Regulatory Requirements, Compliance, Healthcare, Biotechnology, Document Management, Leadership, Business Relationship..., Business Process Mapping, Automation, Electronic Lab Notebooks, System Deployment, IT Management, IT Strategy, Data Center Relocation, Cloud Computing, Enterprise Software, People Management
Education
Arizona State University, W. P. Carey School of Business 2013 — 2014
Master of Science (MS), Information Management, 4.0 / 4.0
Pepperdine University, The George L. Graziadio School of Business and Management 2006 — 2008
BS, Management
Lorrie Wallace's US Data Management Experience August 2010 - Present
Job Business Analyst at US Data Management
Industry Medical Devices
Experience
US Data Management August 2010 - Present
Illumina February 2007 - June 2009
Tyco Healthcare (Covidien) October 2006 - February 2007
Tyco Healthcare (Covidien) May 2004 - October 2006
Avanex January 2000 - April 2004
Siemens (aka: Landis & Gyr, Telegyr Systems) January 1996 - January 2000
Cadint 1993 - 1996
Skills
Validation, Software Documentation, Business Process..., ERP, Testing, Process Improvement, Agile Methodologies, 21 CFR Part 11, Integration, Product Development, System Administration, Program Management, FDA, Document Management, Computer System..., Change Control, Enterprise Software, Manufacturing, Quality Assurance, Quality System
Education
San Jose State University
BA - Industrial Design
US Data Management August 2010 - Present
Illumina February 2007 - June 2009
Tyco Healthcare (Covidien) October 2006 - February 2007
Tyco Healthcare (Covidien) May 2004 - October 2006
Avanex January 2000 - April 2004
Siemens (aka: Landis & Gyr, Telegyr Systems) January 1996 - January 2000
Cadint 1993 - 1996
Skills
Validation, Software Documentation, Business Process..., ERP, Testing, Process Improvement, Agile Methodologies, 21 CFR Part 11, Integration, Product Development, System Administration, Program Management, FDA, Document Management, Computer System..., Change Control, Enterprise Software, Manufacturing, Quality Assurance, Quality System
Education
San Jose State University
BA - Industrial Design
Jerry Anderson's US Data Management Experience 2010 - September 2011
Job Director, Quality Assurance & Compliance at Isis Pharmaceuticals
Industry Pharmaceuticals
Experience
Isis Pharmaceuticals September 2011 - Present
AYSO 1995 - Present
US Data Management 2010 - September 2011
Life Sciences IT Consulting April 2009 - March 2011
Independent 2009 - 2010
Elan Pharmaceuticals 2007 - 2009
ISPE GAMP April 2005 - April 2008
Watson Pharmaceuticals 2003 - 2007
Amgen 1996 - 2003
St. Jude Medical 1992 - 1996
Skills
Validation, Compliance, Risk Management, GAMP, GMP Quality Assurance, GCP Quality Assurance, Computer System..., IT Infrastructure..., Cleaning Validation, Shipping Qualification, Supplier Auditing
Education
California Lutheran University
MBA, IT Management
California Lutheran University
BS, Computer Science
Isis Pharmaceuticals September 2011 - Present
AYSO 1995 - Present
US Data Management 2010 - September 2011
Life Sciences IT Consulting April 2009 - March 2011
Independent 2009 - 2010
Elan Pharmaceuticals 2007 - 2009
ISPE GAMP April 2005 - April 2008
Watson Pharmaceuticals 2003 - 2007
Amgen 1996 - 2003
St. Jude Medical 1992 - 1996
Skills
Validation, Compliance, Risk Management, GAMP, GMP Quality Assurance, GCP Quality Assurance, Computer System..., IT Infrastructure..., Cleaning Validation, Shipping Qualification, Supplier Auditing
Education
California Lutheran University
MBA, IT Management
California Lutheran University
BS, Computer Science
Sean Blake's US Data Management Experience August 2011 - February 2012
Job Director, Information Services at BioCryst Pharmaceuticals
Industry Information Technology and Services
Experience
BioCryst Pharmaceuticals, Inc. February 2015 - Present
FHI 360 February 2012 - Present
US Data Management August 2011 - February 2012
Inspire Pharmaceuticals January 2006 - August 2011
Amphora Discovery Corporation October 2001 - January 2006
Covance Biotechnology Services January 2000 - January 2001
Eli Lilly and Company - RTP Labs January 1997 - January 2000
Eli Lilly and Company January 1995 - January 1997
USF&G Insurance Company January 1992 - January 1995
USF&G Insurance Company January 1986 - January 1992
Skills
SOX, 21 CFR Part 11, Compliance, IT Governance, Process Improvement, Validation, IT Management, Sarbanes-Oxley Act, Governance, Information Technology, FDA, GMP, Quality Assurance, Pharmaceutical Industry, Budgets, Disaster Recovery, Cross-functional Team..., Data Center, Integration, Leadership, Management, Program Management, Project Management, SharePoint, Strategy
Education
University of Maryland Baltimore County 1983 — 1986
BS, Information Systems Management
Villanova University
Masters Certificate, Advanced Information Assurance and Security
BioCryst Pharmaceuticals, Inc. February 2015 - Present
FHI 360 February 2012 - Present
US Data Management August 2011 - February 2012
Inspire Pharmaceuticals January 2006 - August 2011
Amphora Discovery Corporation October 2001 - January 2006
Covance Biotechnology Services January 2000 - January 2001
Eli Lilly and Company - RTP Labs January 1997 - January 2000
Eli Lilly and Company January 1995 - January 1997
USF&G Insurance Company January 1992 - January 1995
USF&G Insurance Company January 1986 - January 1992
Skills
SOX, 21 CFR Part 11, Compliance, IT Governance, Process Improvement, Validation, IT Management, Sarbanes-Oxley Act, Governance, Information Technology, FDA, GMP, Quality Assurance, Pharmaceutical Industry, Budgets, Disaster Recovery, Cross-functional Team..., Data Center, Integration, Leadership, Management, Program Management, Project Management, SharePoint, Strategy
Education
University of Maryland Baltimore County 1983 — 1986
BS, Information Systems Management
Villanova University
Masters Certificate, Advanced Information Assurance and Security
Sherri Obermark's US Data Management Experience 2005 - 2006
Job Sr. Software Test Lead @ INC Research
Industry Pharmaceuticals
Experience
INC Research (formerly Kendle International) July 2011 - Present
Kendle International July 2006 - July 2011
US Data Management 2005 - 2006
dynport vaccine company 2001 - 2003
Skills
Computer System..., 21 CFR Part 11, GAMP, FDA, Validations, GCP, QC, Validation, SOP, CTMS, CAPA, Quality Assurance, Regulatory Requirements, GxP, Sop, Software Documentation, User Acceptance Testing, Testing, Quality Control, Quality System, Software Quality..., Test Planning, Quality Management, V&V, GMP, Cross-functional Team..., Regulatory Affairs, CRO, Clinical Trials, Process Improvement, Pharmaceutical Industry, Biotechnology, Document Management, Documentation, Leadership
Education
Dowling College 1981 — 1983
Bachelor of Arts (BA), English Language and Literature, General
INC Research (formerly Kendle International) July 2011 - Present
Kendle International July 2006 - July 2011
US Data Management 2005 - 2006
dynport vaccine company 2001 - 2003
Skills
Computer System..., 21 CFR Part 11, GAMP, FDA, Validations, GCP, QC, Validation, SOP, CTMS, CAPA, Quality Assurance, Regulatory Requirements, GxP, Sop, Software Documentation, User Acceptance Testing, Testing, Quality Control, Quality System, Software Quality..., Test Planning, Quality Management, V&V, GMP, Cross-functional Team..., Regulatory Affairs, CRO, Clinical Trials, Process Improvement, Pharmaceutical Industry, Biotechnology, Document Management, Documentation, Leadership
Education
Dowling College 1981 — 1983
Bachelor of Arts (BA), English Language and Literature, General
Mary Beth Sattler's US Data Management Experience March 2005 - Present
Job Project Manager at US Data Management
Industry Biotechnology
Experience
US Data Management March 2005 - Present
Dynport Vaccine Company August 2001 - February 2005
Life Technologies, Inc April 1989 - August 2001
Skills
21 CFR Part 11, Computer System..., GxP, GAMP, Validation, PMP, FDA, Change Control, Pharmaceutical Industry, CTMS, Document Management, Software Documentation, CAPA, GMP, V&V, Sop
Education
University of Rochester School of Medicine and Dentistry 1986 — 1989
Masters, Biochemistry
Syracuse University 1980 — 1984
BS, Biology
US Data Management March 2005 - Present
Dynport Vaccine Company August 2001 - February 2005
Life Technologies, Inc April 1989 - August 2001
Skills
21 CFR Part 11, Computer System..., GxP, GAMP, Validation, PMP, FDA, Change Control, Pharmaceutical Industry, CTMS, Document Management, Software Documentation, CAPA, GMP, V&V, Sop
Education
University of Rochester School of Medicine and Dentistry 1986 — 1989
Masters, Biochemistry
Syracuse University 1980 — 1984
BS, Biology
Pankaj Chandak's US Data Management Experience 2006 - 2009
Job Sr. Project Manager at Baxter International Inc.
Industry Pharmaceuticals
Experience
Baxter International Inc. January 2013 - Present
Baxter Healthcare June 2007 - December 2012
Tech Observer June 2005 - December 2012
US Data Management 2006 - 2009
Amgen May 2005 - July 2007
NuLife Pharmaceuticals 2002 - 2003
Eli Lilly 2002 - 2002
Skills
21 CFR Part 11, Risk Assessment, Compliance, Validation, cGMP, Change Control, Computer System..., GMP, GxP, FDA, CAPA, Quality Systems, LIMS, SDLC, Quality Assurance, SOP, Requirements Analysis, Quality Auditing, Quality Management, Process Improvement, GLP, Six Sigma, Pharmaceuticals, Documentation, Auditing, Change Management, Process Validation, GAMP, Pharmaceutical Industry, Quality System, Pharmaceutics, Regulatory Requirements, R&D, ISO, Sop, V&V, Cross-functional Team...
Education
Saint John's University 2003 — 2004
M.S, Pharma Administration: Outcomes Research/Regulatory Affairs, 3.8
University of Pune 1999 — 2002
B.Pharm, Pharmaceutical Sci
RLT College Of Science
HSC
Baxter International Inc. January 2013 - Present
Baxter Healthcare June 2007 - December 2012
Tech Observer June 2005 - December 2012
US Data Management 2006 - 2009
Amgen May 2005 - July 2007
NuLife Pharmaceuticals 2002 - 2003
Eli Lilly 2002 - 2002
Skills
21 CFR Part 11, Risk Assessment, Compliance, Validation, cGMP, Change Control, Computer System..., GMP, GxP, FDA, CAPA, Quality Systems, LIMS, SDLC, Quality Assurance, SOP, Requirements Analysis, Quality Auditing, Quality Management, Process Improvement, GLP, Six Sigma, Pharmaceuticals, Documentation, Auditing, Change Management, Process Validation, GAMP, Pharmaceutical Industry, Quality System, Pharmaceutics, Regulatory Requirements, R&D, ISO, Sop, V&V, Cross-functional Team...
Education
Saint John's University 2003 — 2004
M.S, Pharma Administration: Outcomes Research/Regulatory Affairs, 3.8
University of Pune 1999 — 2002
B.Pharm, Pharmaceutical Sci
RLT College Of Science
HSC
Audreysue Messinger's US Data Management Experience February 2011 - January 2012
Job Technician I at Sanofi for Yoh, A Day & Zimmermann Company
Industry Information Technology and Services
Experience
Yoh, A Day & Zimmermann Company January 2015 - Present
Adecco Staffing, USA November 2014 - December 2014
Yoh, A Day & Zimmermann Company October 2012 - October 2014
Sunrise Systems Inc. July 2012 - October 2012
US Data Management February 2011 - January 2012
AT-Tech Staffing Services, Inc., July 2010 - February 2011
Medarex March 2002 - June 2010
FL Smidth, Inc. November 1995 - August 2001
Skills
LIMS, Validation, GMP, 21 CFR Part 11, Document Management, Quality Control, Change Control, Pharmaceutical Industry, Biotechnology, SOP, Computer System..., FDA, CAPA, Technical Writing, Quality Assurance, Biopharmaceuticals, Regulatory Affairs, Lifesciences, GxP, Technology Transfer, Data Management, GCP, Quality Auditing, HPLC, Quality System, Hope
Education
University of Phoenix 2014 — 2017
Bachelor of Science (BS), Information Technology
Yoh, A Day & Zimmermann Company January 2015 - Present
Adecco Staffing, USA November 2014 - December 2014
Yoh, A Day & Zimmermann Company October 2012 - October 2014
Sunrise Systems Inc. July 2012 - October 2012
US Data Management February 2011 - January 2012
AT-Tech Staffing Services, Inc., July 2010 - February 2011
Medarex March 2002 - June 2010
FL Smidth, Inc. November 1995 - August 2001
Skills
LIMS, Validation, GMP, 21 CFR Part 11, Document Management, Quality Control, Change Control, Pharmaceutical Industry, Biotechnology, SOP, Computer System..., FDA, CAPA, Technical Writing, Quality Assurance, Biopharmaceuticals, Regulatory Affairs, Lifesciences, GxP, Technology Transfer, Data Management, GCP, Quality Auditing, HPLC, Quality System, Hope
Education
University of Phoenix 2014 — 2017
Bachelor of Science (BS), Information Technology