cGMP Validation LLC
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cGMP Validation LLC Employees
Employee
Years
Job
Industry
Kathy Gerst Kathy Gerst's cGMP Validation LLC Experience April 2011 - August 2011
Job Quality Assurance / QC Chemist actively looking for new opportunities in Missouri, Kansas or Colorado
Industry Pharmaceuticals
Experience
IBA Molecular North America October 2012 - March 2015
cGMP Validation LLC April 2011 - August 2011
Aptuit October 2005 - February 2010
Quintiles July 1999 - October 2005
Midwest research institute March 1994 - July 1999
Remel May 1991 - February 1994
Vining laboratory April 1989 - May 1991
Eastridge medical laboratory April 1989 - May 1991
Skills
Pharmaceutical Industry, HPLC, Biotechnology, GMP, GLP, Analytical Chemistry, Validation, FDA, SOP, CRO, Medicine, Hematology, Formulation, Microbiology, Gas Chromatography, Clinical Trials, Phlebotomy, Quality Control, Chemistry, Quality Assurance, Chromatography, Drug Development, Regulatory Affairs, 21 CFR Part 11, Laboratory, Change Control, Clinical Research, Biopharmaceuticals, CAPA, Pharmaceutics, R&D, FTIR, GCP, UV/Vis, GxP, Quality System, Assay Development, ELISA, Method Development, Protocol, Titration, Raw Materials, Aseptic Processing, Quality Auditing, Data Analysis, Manufacturing, Scientific Writing, Life Sciences, Technology Transfer
Education
Missouri Western State University 1983 — 1988
BS, Majors: Math & Biology & Minor: Chemistry
Bishop LeBlond High School St Joseph, MO 1979 — 1983
IBA Molecular North America October 2012 - March 2015
cGMP Validation LLC April 2011 - August 2011
Aptuit October 2005 - February 2010
Quintiles July 1999 - October 2005
Midwest research institute March 1994 - July 1999
Remel May 1991 - February 1994
Vining laboratory April 1989 - May 1991
Eastridge medical laboratory April 1989 - May 1991
Skills
Pharmaceutical Industry, HPLC, Biotechnology, GMP, GLP, Analytical Chemistry, Validation, FDA, SOP, CRO, Medicine, Hematology, Formulation, Microbiology, Gas Chromatography, Clinical Trials, Phlebotomy, Quality Control, Chemistry, Quality Assurance, Chromatography, Drug Development, Regulatory Affairs, 21 CFR Part 11, Laboratory, Change Control, Clinical Research, Biopharmaceuticals, CAPA, Pharmaceutics, R&D, FTIR, GCP, UV/Vis, GxP, Quality System, Assay Development, ELISA, Method Development, Protocol, Titration, Raw Materials, Aseptic Processing, Quality Auditing, Data Analysis, Manufacturing, Scientific Writing, Life Sciences, Technology Transfer
Education
Missouri Western State University 1983 — 1988
BS, Majors: Math & Biology & Minor: Chemistry
Bishop LeBlond High School St Joseph, MO 1979 — 1983
Greg York Greg York's cGMP Validation LLC Experience February 2004 - June 2006
Job HVAC/Cleanroom Technician at AccuTec Services, Inc.
Industry Pharmaceuticals
Experience
AccuTec Services, Inc. June 2006 - Present
cGMP Validation LLC February 2004 - June 2006
Education
Middle Tennessee State University 1989 — 1992
AccuTec Services, Inc. June 2006 - Present
cGMP Validation LLC February 2004 - June 2006
Education
Middle Tennessee State University 1989 — 1992
Emily Diaz Emily Diaz's cGMP Validation LLC Experience July 2011 - May 2014
Job
Industry Biotechnology
Experience
AstraZeneca September 2014 - Present
Quality Agents, LLC May 2014 - September 2014
cGMP Validation LLC July 2011 - May 2014
BioReliance January 2010 - July 2012
BioReliance October 2007 - December 2009
BioReliance November 2005 - October 2007
Clinical Research Management October 2004 - November 2005
Clinical Research Management December 2003 - October 2004
FDA January 2003 - May 2003
University of Maryland September 2001 - May 2002
Skills
Validation, Change Control, Quality Control, Sop, V&V, Laboratory, Microbiology, Quality Assurance
Education
University of Maryland College Park 1999 — 2003
BS
AstraZeneca September 2014 - Present
Quality Agents, LLC May 2014 - September 2014
cGMP Validation LLC July 2011 - May 2014
BioReliance January 2010 - July 2012
BioReliance October 2007 - December 2009
BioReliance November 2005 - October 2007
Clinical Research Management October 2004 - November 2005
Clinical Research Management December 2003 - October 2004
FDA January 2003 - May 2003
University of Maryland September 2001 - May 2002
Skills
Validation, Change Control, Quality Control, Sop, V&V, Laboratory, Microbiology, Quality Assurance
Education
University of Maryland College Park 1999 — 2003
BS
A. Kyle Kennedy A. Kyle Kennedy's cGMP Validation LLC Experience 2000 - 2005
Job
Industry Biotechnology
Experience
Mylan August 2014 - Present
Kennedy Compliance, Inc. 2005 - Present
Olympus Biotech Corporation 2011 - 2014
Stryker Biotech 2007 - February 2011
cGMP Validation, LLC 2000 - 2005
75th Street Brewery 1997 - 2000
Akers Kennedy and Associates 1995 - 2000
Skills
Validation, Sop, Environmental Monitoring, Manufacturing, Management, Team Leadership, Biotechnology, Quality Assurance, Facilities Management, GMP, FDA, Sterilization, V&V, Quality System, ISO 13485, CAPA, Change Control, Computer System..., GxP, Technology Transfer, Aseptic Processing, Biopharmaceuticals, 21 CFR Part 11, Quality Control, Medical Devices, Quality Auditing, Lifesciences, Cleaning Validation, Pharmaceutical Industry, GLP, GAMP, Regulatory Affairs, Validation Master Plans, Quality Management, Cross-functional Team..., Commissioning, Microbiology, FDA GMP, Regulatory Requirements, Software Documentation, Isolators, Quality Risk Management, Equipment Qualification, Process Validation, Training, Depyrogenation, Validation Lifecycle, SOP
Education
Stevens Institute of Technology 2010 — 2012
Master of Science (MS)
University of Missouri-Kansas City
Post-Grad
University of Vermont
BA
Don Bosco Prep High School
Mylan August 2014 - Present
Kennedy Compliance, Inc. 2005 - Present
Olympus Biotech Corporation 2011 - 2014
Stryker Biotech 2007 - February 2011
cGMP Validation, LLC 2000 - 2005
75th Street Brewery 1997 - 2000
Akers Kennedy and Associates 1995 - 2000
Skills
Validation, Sop, Environmental Monitoring, Manufacturing, Management, Team Leadership, Biotechnology, Quality Assurance, Facilities Management, GMP, FDA, Sterilization, V&V, Quality System, ISO 13485, CAPA, Change Control, Computer System..., GxP, Technology Transfer, Aseptic Processing, Biopharmaceuticals, 21 CFR Part 11, Quality Control, Medical Devices, Quality Auditing, Lifesciences, Cleaning Validation, Pharmaceutical Industry, GLP, GAMP, Regulatory Affairs, Validation Master Plans, Quality Management, Cross-functional Team..., Commissioning, Microbiology, FDA GMP, Regulatory Requirements, Software Documentation, Isolators, Quality Risk Management, Equipment Qualification, Process Validation, Training, Depyrogenation, Validation Lifecycle, SOP
Education
Stevens Institute of Technology 2010 — 2012
Master of Science (MS)
University of Missouri-Kansas City
Post-Grad
University of Vermont
BA
Don Bosco Prep High School
Doug Shaw CISA, CRISC Doug Shaw CISA, CRISC's cGMP Validation LLC Experience March 2007 - January 2015
Job Director of IT & CSV Consulting at Azzur Group
Industry Medical Devices
Experience
Azzur Group January 2015 - Present
cGMP Validation LLC March 2007 - January 2015
Actavis 2002 - 2007
Genentech 1999 - June 2002
Bayer 1996 - 1998
Calypte Biomedical 1995 - 1996
Biowhittaker Inc. 1992 - 1995
Skills
21 CFR Part 11, Computer System..., Validation, GMP, CAPA, ISO 13485, Medical Devices, LIMS, ISO 14971, FDA, Software Quality..., Document Management, Software Documentation, Laboratory Automation, Cloud Computing, Risk Management, Risk Assessment, HIPAA, SAP, Software Project..., MS Project, Regression Testing, ERP, Software Engineering, Data Security, SaaS, System Testing, Computer Security, Risk Mitigation, IT Auditing, Healthcare IT, IT Governance, IT Outsourcing, Life Sciences, Software Design, Compliance Audits, Software Development..., 21CFR Part 820, 21CFR Part 210/ 211, ISO 62304, HIPAA Security Rule, Data Privacy, Laboratory Experience, Healthcare Compliance, cGMP, Pharmaceuticals, SOP/ Policy Development, Integration Testing, Quality Systems, V&V
Education
Hood College 1993 — 2000
MS, Biology
Radford University 1987 — 1991
BS, Biology, Chemistry
Azzur Group January 2015 - Present
cGMP Validation LLC March 2007 - January 2015
Actavis 2002 - 2007
Genentech 1999 - June 2002
Bayer 1996 - 1998
Calypte Biomedical 1995 - 1996
Biowhittaker Inc. 1992 - 1995
Skills
21 CFR Part 11, Computer System..., Validation, GMP, CAPA, ISO 13485, Medical Devices, LIMS, ISO 14971, FDA, Software Quality..., Document Management, Software Documentation, Laboratory Automation, Cloud Computing, Risk Management, Risk Assessment, HIPAA, SAP, Software Project..., MS Project, Regression Testing, ERP, Software Engineering, Data Security, SaaS, System Testing, Computer Security, Risk Mitigation, IT Auditing, Healthcare IT, IT Governance, IT Outsourcing, Life Sciences, Software Design, Compliance Audits, Software Development..., 21CFR Part 820, 21CFR Part 210/ 211, ISO 62304, HIPAA Security Rule, Data Privacy, Laboratory Experience, Healthcare Compliance, cGMP, Pharmaceuticals, SOP/ Policy Development, Integration Testing, Quality Systems, V&V
Education
Hood College 1993 — 2000
MS, Biology
Radford University 1987 — 1991
BS, Biology, Chemistry
Stephen Ferrell Stephen Ferrell's cGMP Validation LLC Experience 2001 - 2003
Job VP GRC at ByteGrid/Sidus BioData
Industry Pharmaceuticals
Experience
ByteGrid August 2015 - Present
Sidus BioData - a ByteGrid Company January 2014 - August 2015
Premier Research September 2012 - January 2014
QIAGEN July 2010 - September 2012
Qiagen April 2006 - July 2010
Digene 2005 - 2007
Alpharma 2003 - April 2005
cGMP Validation, LLC 2001 - 2003
Lucent Technologies 2000 - 2002
Skills
Validation, Quality Assurance, FDA, Computer System..., Medical Devices, 21 CFR Part 11, V&V, Testing, GxP, Change Control, Biotechnology, Quality Auditing, GAMP, Sop, Software Quality..., Design Control, ISO 13485, GMP, Change Management, Requirements Analysis, Software Validation, ISO 14971, Risk Management, Regulatory Affairs, Quality Management, SDLC, Auditing, Automation, ITIL, HIPAA, Cloud Computing, Risk Assessment, SAP, Team Leadership, QSR, IEC62034, Annex 11, Healthcare IT, Quality Systems, Process Validation, Compliance, SOX, IT Risk, CRISC, Class III Medical..., cGMP, Healthcare Information..., Pharmaceutical Industry, Information Technology, Quality System
Education
Penn State University
Bachelor of Science (BS), Management Science & Information Systems
Queen Margaret Academy, Ayr
ByteGrid August 2015 - Present
Sidus BioData - a ByteGrid Company January 2014 - August 2015
Premier Research September 2012 - January 2014
QIAGEN July 2010 - September 2012
Qiagen April 2006 - July 2010
Digene 2005 - 2007
Alpharma 2003 - April 2005
cGMP Validation, LLC 2001 - 2003
Lucent Technologies 2000 - 2002
Skills
Validation, Quality Assurance, FDA, Computer System..., Medical Devices, 21 CFR Part 11, V&V, Testing, GxP, Change Control, Biotechnology, Quality Auditing, GAMP, Sop, Software Quality..., Design Control, ISO 13485, GMP, Change Management, Requirements Analysis, Software Validation, ISO 14971, Risk Management, Regulatory Affairs, Quality Management, SDLC, Auditing, Automation, ITIL, HIPAA, Cloud Computing, Risk Assessment, SAP, Team Leadership, QSR, IEC62034, Annex 11, Healthcare IT, Quality Systems, Process Validation, Compliance, SOX, IT Risk, CRISC, Class III Medical..., cGMP, Healthcare Information..., Pharmaceutical Industry, Information Technology, Quality System
Education
Penn State University
Bachelor of Science (BS), Management Science & Information Systems
Queen Margaret Academy, Ayr
David Denkhaus David Denkhaus's cGMP Validation LLC Experience March 2015 - Present
Job Life Sciences
Industry Pharmaceuticals
Experience
cGMP Validation LLC March 2015 - Present
Dermazone Solutions April 2014 - March 2015
The Staffing Resource Group - Science and Engineering November 2011 - August 2013
Life Sciences and Engineering Staffing Agency August 2010 - November 2011
Kelly Scientific Resources January 2008 - August 2010
Kelly Scientific Resources March 2006 - January 2008
Ecolab May 2004 - August 2005
Pepsico Beverages and Foods February 2001 - March 2004
Skills
Engineering, Technical Recruiting, Project Management, Manufacturing, Recruiting, Science, Microbiology, Chemistry, Executive Search, Staffing Services, Benefits Negotiation, Temporary Placement, Internet Recruiting, New Business Development, Sourcing, Human Resources, Lifesciences, Applicant Tracking..., Talent Acquisition, Contract Recruitment, Leadership, Screening Resumes, Temporary Staffing, Validation, Cleaning Validation, Analytical Method..., Sales, Training, Management, College Recruiting, Consulting, Screening, Interviews, Talent Management, Business Development, Onboarding, Biotechnology, Performance Management, Strategy, R&D, Medical Devices, Hiring, GMP, Sop, Quality Assurance, Cold Calling, Employee Benefits, Laboratory, Program Management, Account Building
Education
University of South Florida 1994 — 1999
cGMP Validation LLC March 2015 - Present
Dermazone Solutions April 2014 - March 2015
The Staffing Resource Group - Science and Engineering November 2011 - August 2013
Life Sciences and Engineering Staffing Agency August 2010 - November 2011
Kelly Scientific Resources January 2008 - August 2010
Kelly Scientific Resources March 2006 - January 2008
Ecolab May 2004 - August 2005
Pepsico Beverages and Foods February 2001 - March 2004
Skills
Engineering, Technical Recruiting, Project Management, Manufacturing, Recruiting, Science, Microbiology, Chemistry, Executive Search, Staffing Services, Benefits Negotiation, Temporary Placement, Internet Recruiting, New Business Development, Sourcing, Human Resources, Lifesciences, Applicant Tracking..., Talent Acquisition, Contract Recruitment, Leadership, Screening Resumes, Temporary Staffing, Validation, Cleaning Validation, Analytical Method..., Sales, Training, Management, College Recruiting, Consulting, Screening, Interviews, Talent Management, Business Development, Onboarding, Biotechnology, Performance Management, Strategy, R&D, Medical Devices, Hiring, GMP, Sop, Quality Assurance, Cold Calling, Employee Benefits, Laboratory, Program Management, Account Building
Education
University of South Florida 1994 — 1999
Christian Clemens Christian Clemens's cGMP Validation LLC Experience July 2015 - Present
Job Validation Specialist at cGMP Validation LLC
Industry Pharmaceuticals
Experience
cGMP Validation LLC July 2015 - Present
Purdue Pharma L.P. July 2015 - Present
Wellcare Parmacy LLC August 2014 - May 2015
Stewart Compounding Pharmacy April 2013 - July 2014
Medical Center Pharmacy January 2009 - April 2013
Skills
Quality Assurance, CAPA, Validation, Sop, FDA, Quality Management, GLP, Pharmaceutical Industry, Cleaning Validation, Medical Devices, Aseptic Processing, Continuous Improvement, Quality Control, Regulatory Affairs, Analytical Chemistry, USP, Sterilization, Aseptic Technique, SOP development
Education
University of North Carolina at Wilmington 2005 — 2008
Bachelor of Science (BS), Biology, General
Fayetteville Technical Community College
Associate's degree, Biology/Biological Sciences, General
cGMP Validation LLC July 2015 - Present
Purdue Pharma L.P. July 2015 - Present
Wellcare Parmacy LLC August 2014 - May 2015
Stewart Compounding Pharmacy April 2013 - July 2014
Medical Center Pharmacy January 2009 - April 2013
Skills
Quality Assurance, CAPA, Validation, Sop, FDA, Quality Management, GLP, Pharmaceutical Industry, Cleaning Validation, Medical Devices, Aseptic Processing, Continuous Improvement, Quality Control, Regulatory Affairs, Analytical Chemistry, USP, Sterilization, Aseptic Technique, SOP development
Education
University of North Carolina at Wilmington 2005 — 2008
Bachelor of Science (BS), Biology, General
Fayetteville Technical Community College
Associate's degree, Biology/Biological Sciences, General
Mark Curnutt's cGMP Validation LLC Experience March 2007 - July 2013
Job
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions July 2013 - Present
cGMP Validation LLC March 2007 - July 2013
Aptuit, Inc. 2005 - 2007
Quintiles 2002 - 2005
ChemSyn Science Laboratories 1985 - 2002
Skills
Quality Assurance, GMP, Validation, Compliance, Pharmaceuticals, Quality Systems, Regulatory Affairs, Protocol Writing, Documentation, Quality Auditing, Quality System, Pharmaceutical Industry, GLP, Sop, Change Control, FDA, Cleaning Validation, Lifesciences, Aseptic Processing, GAMP, Quality Control, Biopharmaceuticals, CAPA, Life Sciences, V&V, Computer System..., SOP, Software Documentation
Education
Longview Community College 1980 — 1984
AS, Chemistry
Catalent Pharma Solutions July 2013 - Present
cGMP Validation LLC March 2007 - July 2013
Aptuit, Inc. 2005 - 2007
Quintiles 2002 - 2005
ChemSyn Science Laboratories 1985 - 2002
Skills
Quality Assurance, GMP, Validation, Compliance, Pharmaceuticals, Quality Systems, Regulatory Affairs, Protocol Writing, Documentation, Quality Auditing, Quality System, Pharmaceutical Industry, GLP, Sop, Change Control, FDA, Cleaning Validation, Lifesciences, Aseptic Processing, GAMP, Quality Control, Biopharmaceuticals, CAPA, Life Sciences, V&V, Computer System..., SOP, Software Documentation
Education
Longview Community College 1980 — 1984
AS, Chemistry
Samuel deGuzman Samuel deGuzman's cGMP Validation LLC Experience December 2012 - April 2013
Job Experienced Life Sciences Professional
Industry Biotechnology
Experience
Leidos Biomedical Research, Inc. October 2013 - Present
SAIC-Frederick April 2013 - November 2013
cGMP Validation LLC December 2012 - April 2013
OpGen May 2010 - October 2011
MedImmune January 2010 - May 2010
Skills
Biotechnology, Aseptic Technique, Aseptic Processing, Supervisory Skills, Laboratory Safety, Employee Training, Youth Mentoring, Positive Youth..., GMP, GLP, GDP, Quality Assurance, Quality Control, DNA, Lifesciences
Education
University of Maryland University College
Biotechnology Management
Frostburg State University 2005 — 2009
BS, Biology
Leidos Biomedical Research, Inc. October 2013 - Present
SAIC-Frederick April 2013 - November 2013
cGMP Validation LLC December 2012 - April 2013
OpGen May 2010 - October 2011
MedImmune January 2010 - May 2010
Skills
Biotechnology, Aseptic Technique, Aseptic Processing, Supervisory Skills, Laboratory Safety, Employee Training, Youth Mentoring, Positive Youth..., GMP, GLP, GDP, Quality Assurance, Quality Control, DNA, Lifesciences
Education
University of Maryland University College
Biotechnology Management
Frostburg State University 2005 — 2009
BS, Biology
Mark P. O'Donnell Mark P. O'Donnell's cGMP Validation LLC Experience 2000 - 2003
Job Principal at Peak Performance Global Services, LLC (Career Agent & Recruiter)
Industry Pharmaceuticals
Experience
Peak Performance Global Services, LLC January 2014 - Present
PharmEng Technology January 2012 - January 2014
Biogen Idec 2010 - 2011
Azzur Group 2010 - 2011
Sanofi Pasteur 2006 - 2011
Jacobs Engineering 2003 - 2005
cGMP Validation LLC 2000 - 2003
Merck 1994 - 2002
Raytheon Engineers 1990 - 1998
United States Air Force 1976 - 1982
Skills
Business Development, Project Management, Team Building, Computer System..., Change Control, V&V, 21 CFR Part 11, Validation, GxP, CAPA, FDA, GMP, Sop, Biopharmaceuticals, Pharmaceutical Industry, Quality Management, Biotechnology, GAMP, Quality System, Management, Vaccines, Manufacturing, Commissioning, Technology Transfer, Aseptic Processing, Six Sigma, GLP, Industrial Engineering, Regulatory Affairs, Project Engineering, Root Cause Analysis, Medical Devices, Quality Assurance, Quality Control, Cleaning Validation, ISO 13485, Engineering, Strategy, Pharmaceutics, LIMS, Process Simulation, Regulatory Requirements, Lifesciences, Regulatory Submissions, Quality Auditing, Process Engineering, R&D, Drug Development, Document Management, People Skills
Education
Lehigh County Community College 1978 — 1982
Business Management
Troy State University 1977 — 1978
Business Management
Peak Performance Global Services, LLC January 2014 - Present
PharmEng Technology January 2012 - January 2014
Biogen Idec 2010 - 2011
Azzur Group 2010 - 2011
Sanofi Pasteur 2006 - 2011
Jacobs Engineering 2003 - 2005
cGMP Validation LLC 2000 - 2003
Merck 1994 - 2002
Raytheon Engineers 1990 - 1998
United States Air Force 1976 - 1982
Skills
Business Development, Project Management, Team Building, Computer System..., Change Control, V&V, 21 CFR Part 11, Validation, GxP, CAPA, FDA, GMP, Sop, Biopharmaceuticals, Pharmaceutical Industry, Quality Management, Biotechnology, GAMP, Quality System, Management, Vaccines, Manufacturing, Commissioning, Technology Transfer, Aseptic Processing, Six Sigma, GLP, Industrial Engineering, Regulatory Affairs, Project Engineering, Root Cause Analysis, Medical Devices, Quality Assurance, Quality Control, Cleaning Validation, ISO 13485, Engineering, Strategy, Pharmaceutics, LIMS, Process Simulation, Regulatory Requirements, Lifesciences, Regulatory Submissions, Quality Auditing, Process Engineering, R&D, Drug Development, Document Management, People Skills
Education
Lehigh County Community College 1978 — 1982
Business Management
Troy State University 1977 — 1978
Business Management
William Chestnut William Chestnut's cGMP Validation LLC Experience June 2008 - November 2009
Job GLP/GCP IT Validation Lead
Industry Pharmaceuticals
Experience
Genentech April 2014 - Present
USDM May 2012 - April 2014
Abbott Vascular August 2010 - May 2012
cGMP Validation, LLC June 2008 - November 2009
PDL BioPharma August 2006 - May 2008
PDL BioPharma February 2005 - August 2006
Lloyd's Register Serentec January 2001 - February 2005
Burroughs Wellcome 1986 - 1995
Skills
Project Management, GLP, Quality System, Change Management, Pharmaceutical Industry, Validation, Sop, Process Simulation, Laboratory, GCP, FDA, Computer System..., V&V, 21 CFR Part 11, Testing, Lifesciences, Quality Control, GxP, Pharmaceutics, CAPA, Change Control, Biotechnology, Clinical Trials, GAMP, LIMS, Manufacturing, SOP
Education
North Carolina State University - College of Management 1999 — 2000
Master's of Science, Management (MSM)
Cornell University 1974 — 1978
B.Sc.
Genentech April 2014 - Present
USDM May 2012 - April 2014
Abbott Vascular August 2010 - May 2012
cGMP Validation, LLC June 2008 - November 2009
PDL BioPharma August 2006 - May 2008
PDL BioPharma February 2005 - August 2006
Lloyd's Register Serentec January 2001 - February 2005
Burroughs Wellcome 1986 - 1995
Skills
Project Management, GLP, Quality System, Change Management, Pharmaceutical Industry, Validation, Sop, Process Simulation, Laboratory, GCP, FDA, Computer System..., V&V, 21 CFR Part 11, Testing, Lifesciences, Quality Control, GxP, Pharmaceutics, CAPA, Change Control, Biotechnology, Clinical Trials, GAMP, LIMS, Manufacturing, SOP
Education
North Carolina State University - College of Management 1999 — 2000
Master's of Science, Management (MSM)
Cornell University 1974 — 1978
B.Sc.
Benjamin Frey's cGMP Validation LLC Experience January 2000 - January 2002
Job Principal Compliance Consultant at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group February 2014 - Present
ProPharma Group January 2010 - February 2014
ProPharma Group 2005 - December 2009
Eagle Picher Pharmaceutical Services 2002 - 2005
CGMP Validation, LLC January 2000 - January 2002
Antigen Laboratories January 1998 - January 2000
University of New Mexico January 1997 - January 1998
Mallinckrodt Veterinary (Coopers Animal Health), Assoc January 1993 - January 1997
Johnson County Community College January 1993 - January 1994
University of Kansas Medical Center January 1992 - January 1993
Skills
GMP, Validation, Quality Assurance, cGMP, Quality Systems, CAPA, Quality Management, Quality Auditing, Pharmaceuticals, SOP, Change Control, GxP, Quality System, Pharmaceutical Industry, Sop, Strategic Leadership, Team Management, 21 CFR Part 11, GLP, FDA, V&V, Cleaning Validation, Biotechnology, Medical Devices, Computer System..., Biopharmaceuticals, LIMS, Trackwise, GAMP, TrackWise
Education
Emporia State University 1992 — 1993
Master of Science, Biology
The University of Kansas
Bachelor of Science, Biology
ProPharma Group February 2014 - Present
ProPharma Group January 2010 - February 2014
ProPharma Group 2005 - December 2009
Eagle Picher Pharmaceutical Services 2002 - 2005
CGMP Validation, LLC January 2000 - January 2002
Antigen Laboratories January 1998 - January 2000
University of New Mexico January 1997 - January 1998
Mallinckrodt Veterinary (Coopers Animal Health), Assoc January 1993 - January 1997
Johnson County Community College January 1993 - January 1994
University of Kansas Medical Center January 1992 - January 1993
Skills
GMP, Validation, Quality Assurance, cGMP, Quality Systems, CAPA, Quality Management, Quality Auditing, Pharmaceuticals, SOP, Change Control, GxP, Quality System, Pharmaceutical Industry, Sop, Strategic Leadership, Team Management, 21 CFR Part 11, GLP, FDA, V&V, Cleaning Validation, Biotechnology, Medical Devices, Computer System..., Biopharmaceuticals, LIMS, Trackwise, GAMP, TrackWise
Education
Emporia State University 1992 — 1993
Master of Science, Biology
The University of Kansas
Bachelor of Science, Biology
Thomas Paul Raimondi Thomas Paul Raimondi's cGMP Validation LLC Experience March 2005 - January 2007
Job Computer Validation Engineer at Allergan
Industry Pharmaceuticals
Experience
Allergan (Formerly Actavis) February 2007 - Present
cGMP Validation, LLC March 2005 - January 2007
Alpharma August 2003 - March 2005
cGMP Validation, LLC September 2001 - August 2003
Accutest Laboratories August 1997 - August 2001
Skills
Computer System..., IT Audit, Risk Assessment, 21 CFR Part 11, Validation, Electronic Signatures, cGMP, Documentation, Change Control, GAMP, GxP, GMP, CAPA, Software Validation, FDA, Quality Assurance, Calibration, Laboratory Experience, Testing, IT Strategy, Compliance, Disaster Recovery, ERP, Electronic Document, Document Review, Staff Training, Training & Development, SME, Laboratory, Software Documentation, Equipment Qualification, Aseptic Processing, Quality System, Pharmaceutics, USP, Trackwise, Deviations, GLP, UV/Vis, LIMS, Dissolution, V&V, Technology Transfer, Pharmaceutical Industry, Quality Auditing, Employee Training, Sop, Regulatory Requirements, Regulatory Affairs, Biopharmaceuticals
Education
University of North Carolina at Wilmington 1993 — 1995
BS, Biology
Ocean County College 1990 — 1993
AS, General Ed. - Computer Science
Allergan (Formerly Actavis) February 2007 - Present
cGMP Validation, LLC March 2005 - January 2007
Alpharma August 2003 - March 2005
cGMP Validation, LLC September 2001 - August 2003
Accutest Laboratories August 1997 - August 2001
Skills
Computer System..., IT Audit, Risk Assessment, 21 CFR Part 11, Validation, Electronic Signatures, cGMP, Documentation, Change Control, GAMP, GxP, GMP, CAPA, Software Validation, FDA, Quality Assurance, Calibration, Laboratory Experience, Testing, IT Strategy, Compliance, Disaster Recovery, ERP, Electronic Document, Document Review, Staff Training, Training & Development, SME, Laboratory, Software Documentation, Equipment Qualification, Aseptic Processing, Quality System, Pharmaceutics, USP, Trackwise, Deviations, GLP, UV/Vis, LIMS, Dissolution, V&V, Technology Transfer, Pharmaceutical Industry, Quality Auditing, Employee Training, Sop, Regulatory Requirements, Regulatory Affairs, Biopharmaceuticals
Education
University of North Carolina at Wilmington 1993 — 1995
BS, Biology
Ocean County College 1990 — 1993
AS, General Ed. - Computer Science
Mark P. O'Donnell Mark P. O'Donnell's cGMP Validation LLC Experience 2000 - 2003
Job Project Manager
Industry Pharmaceuticals
Experience
sanofi pasteur November 2006 - Present
Genesis Engineers 2006 - 2008
Jacobs Engineering 2004 - 2006
Jacobs Engineering Group, Inc. 2003 - 2005
O'Brien & Gere 2003 - 2004
cGMP Validation LLC 2000 - 2003
Merck Sharp & Dohme 1997 - 2000
Merck & Co., Inc 1994 - 2000
Raytheon Engineers 1990 - 1998
Life Sciences International 1992 - 1992
Education
Kutztown University of Pennsylvania
Cost Accounting
Lehigh County Community College
AAS, Business Management / Mechanical Technology
Thomas Edison State College
Organizational Management
sanofi pasteur November 2006 - Present
Genesis Engineers 2006 - 2008
Jacobs Engineering 2004 - 2006
Jacobs Engineering Group, Inc. 2003 - 2005
O'Brien & Gere 2003 - 2004
cGMP Validation LLC 2000 - 2003
Merck Sharp & Dohme 1997 - 2000
Merck & Co., Inc 1994 - 2000
Raytheon Engineers 1990 - 1998
Life Sciences International 1992 - 1992
Education
Kutztown University of Pennsylvania
Cost Accounting
Lehigh County Community College
AAS, Business Management / Mechanical Technology
Thomas Edison State College
Organizational Management
Jennifer Amos's cGMP Validation LLC Experience May 2013 - June 2015
Job Validation Engineer at Kaztronix LLC
Industry Pharmaceuticals
Experience
Kaztronix LLC June 2015 - Present
cGMP Validation LLC May 2013 - June 2015
Staffing Resource Group, Inc December 2012 - March 2013
Skills
Validation, Microsoft Word, Microsoft Excel, Aseptic Technique, Protocol Execution, SOP, Equipment Validation, Results Analysis, Deviations, GMP, Public Speaking, FDA, Temperature Mapping, Environmental Monitoring, Protocol Development, Installation..., Operational Qualifiction, Performance..., MadgeTech Wireless..., Final Reports, Interim Reports, GDP, Kaye Validator 2000, Aseptic Gowning, Microsoft Outlook, eDOCs (Qumas), Attention to Detail, Organized, Effective Written and..., Smoke Testing
Education
Loyola Marymount University, Seaver College of Science and Engineering 2008 — 2012
Bachelor of Science (B.S.), Natural Science
Kaztronix LLC June 2015 - Present
cGMP Validation LLC May 2013 - June 2015
Staffing Resource Group, Inc December 2012 - March 2013
Skills
Validation, Microsoft Word, Microsoft Excel, Aseptic Technique, Protocol Execution, SOP, Equipment Validation, Results Analysis, Deviations, GMP, Public Speaking, FDA, Temperature Mapping, Environmental Monitoring, Protocol Development, Installation..., Operational Qualifiction, Performance..., MadgeTech Wireless..., Final Reports, Interim Reports, GDP, Kaye Validator 2000, Aseptic Gowning, Microsoft Outlook, eDOCs (Qumas), Attention to Detail, Organized, Effective Written and..., Smoke Testing
Education
Loyola Marymount University, Seaver College of Science and Engineering 2008 — 2012
Bachelor of Science (B.S.), Natural Science
Dana McCormick Dana McCormick's cGMP Validation LLC Experience January 2013 - February 2014
Job Independent Business Owner/Manager at DanaMcC LLC dba The Little Pottery Shop
Industry Management Consulting
Experience
cGMP Validation LLC January 2013 - February 2014
Mail Systems Management Consultants May 2012 - September 2012
Wells Fargo Bank, NA October 2002 - August 2011
Precise Systems March 2002 - September 2002
Hecht's Department Stores August 1994 - January 2001
Skills
Customer Service, Budgeting, Operations Management, PowerPoint, Word, Team Building, Supervisory Skills, Business Analysis, Logistics, Budgets, Event Planning, Performance Management, Personal Development, Public Speaking, Business Process..., Customer Insight, Budget Setting, Goal Oriented, Inventory Management, Shortage Control, Management Consulting, Quality Control, Move Management, Employee Training, Strategic Planning, Training, Program Management, Government, Project Planning, Coaching, Customer Satisfaction, Management, Leadership, Process Improvement
Education
Penn State University
BS, Business Logistics
Montgomery College
Certificate, Tech leap
cGMP Validation LLC January 2013 - February 2014
Mail Systems Management Consultants May 2012 - September 2012
Wells Fargo Bank, NA October 2002 - August 2011
Precise Systems March 2002 - September 2002
Hecht's Department Stores August 1994 - January 2001
Skills
Customer Service, Budgeting, Operations Management, PowerPoint, Word, Team Building, Supervisory Skills, Business Analysis, Logistics, Budgets, Event Planning, Performance Management, Personal Development, Public Speaking, Business Process..., Customer Insight, Budget Setting, Goal Oriented, Inventory Management, Shortage Control, Management Consulting, Quality Control, Move Management, Employee Training, Strategic Planning, Training, Program Management, Government, Project Planning, Coaching, Customer Satisfaction, Management, Leadership, Process Improvement
Education
Penn State University
BS, Business Logistics
Montgomery College
Certificate, Tech leap
Sami Tadruss Sami Tadruss's cGMP Validation LLC Experience September 2001 - March 2003
Job Manager Sr, World Wide Manufacturing Support at Allergan
Industry Pharmaceuticals
Experience
Allergan December 2007 - Present
Advanced Medical Optics (Abbott -AMO) March 2003 - December 2007
cGMP Validation LLC September 2001 - March 2003
Global Napi Pharmaceutical (GNP) March 1996 - July 2001
Glaxo smith Kline (GSK) 1990 - 1996
Skills
Manufacturing, FDA, GMP, Validation, Technology Transfer, Pharmaceutical Industry
Education
Cairo University 1977 — 1982
Bachelor's degree, Mechanical Engineering
Allergan December 2007 - Present
Advanced Medical Optics (Abbott -AMO) March 2003 - December 2007
cGMP Validation LLC September 2001 - March 2003
Global Napi Pharmaceutical (GNP) March 1996 - July 2001
Glaxo smith Kline (GSK) 1990 - 1996
Skills
Manufacturing, FDA, GMP, Validation, Technology Transfer, Pharmaceutical Industry
Education
Cairo University 1977 — 1982
Bachelor's degree, Mechanical Engineering
Christopher Root Christopher Root's cGMP Validation LLC Experience 2002 - 2003
Job Senior Automation Analyst at Merck
Industry Pharmaceuticals
Experience
Merck May 2008 - Present
Root Validation Services January 2003 - May 2008
ICON Clinical Research March 2007 - January 2008
ICON Clinical Research September 2006 - March 2007
Root Validation Services June 2002 - September 2006
cGMP Validation, LLC 2002 - 2003
cGMP Validation LLC 2002 - 2003
First Consulting Group 2000 - 2002
Raytheon Engineers and Constructors 1998 - 2000
Taratec 1997 - 1998
Skills
21 CFR Part 11, Pharmaceutical Industry, GMP, SOP, Validation, Change Control
Education
Rochester Institute of Technology 1984 — 1990
BS, Biotechology
Merck May 2008 - Present
Root Validation Services January 2003 - May 2008
ICON Clinical Research March 2007 - January 2008
ICON Clinical Research September 2006 - March 2007
Root Validation Services June 2002 - September 2006
cGMP Validation, LLC 2002 - 2003
cGMP Validation LLC 2002 - 2003
First Consulting Group 2000 - 2002
Raytheon Engineers and Constructors 1998 - 2000
Taratec 1997 - 1998
Skills
21 CFR Part 11, Pharmaceutical Industry, GMP, SOP, Validation, Change Control
Education
Rochester Institute of Technology 1984 — 1990
BS, Biotechology
Ebyson Thomas Ebyson Thomas's cGMP Validation LLC Experience March 2012 - May 2014
Job Sr. Validation Engineer at Merck
Industry Semiconductors
Experience
Merck June 2014 - Present
cGMP Validation LLC March 2012 - May 2014
LSI Corp October 2000 - January 2012
Skills
Validation, Design of Experiments, IC, V&V, Manufacturing, Simulations, SOP, Software Documentation, Cross-functional Team..., GMP, Engineering, R&D
Education
Campion School
University of Pune
Merck June 2014 - Present
cGMP Validation LLC March 2012 - May 2014
LSI Corp October 2000 - January 2012
Skills
Validation, Design of Experiments, IC, V&V, Manufacturing, Simulations, SOP, Software Documentation, Cross-functional Team..., GMP, Engineering, R&D
Education
Campion School
University of Pune
Jacek Nowakowski Jacek Nowakowski's cGMP Validation LLC Experience November 2003 - November 2010
Job Principle Nuclear V&V Engineer at Schneider Electric
Industry Industrial Automation
Experience
Schneider Electric November 2010 - Present
cGMP Validation LLC November 2003 - November 2010
Amylin Ohio LLC October 2006 - October 2010
Skills
21 CFR Part 11, Automation, Change Control, Commissioning, Computer System..., DCS, Engineering, GAMP, GMP, Process Control, Process Simulation, Program Management, Project Engineering, Quality Assurance, Root Cause Analysis, V, Validation, V&V, Testing
Education
Northeastern University 1992 — 1997
BS, Chemical Engineering
Schneider Electric November 2010 - Present
cGMP Validation LLC November 2003 - November 2010
Amylin Ohio LLC October 2006 - October 2010
Skills
21 CFR Part 11, Automation, Change Control, Commissioning, Computer System..., DCS, Engineering, GAMP, GMP, Process Control, Process Simulation, Program Management, Project Engineering, Quality Assurance, Root Cause Analysis, V, Validation, V&V, Testing
Education
Northeastern University 1992 — 1997
BS, Chemical Engineering
Charles Yourdon's cGMP Validation LLC Experience March 2011 - October 2011
Job Principal Specialist (Global Quality Services, Animal Health) at Boehringer Ingelheim Vetmedica
Industry Pharmaceuticals
Experience
Boehringer Ingelheim Vetmedica March 2013 - Present
Boehringer Ingelheim Vetmedica October 2011 - March 2013
cGMP Validation, LLC March 2011 - October 2011
cGMP Validation, LLC October 2009 - March 2011
Aptuit October 2008 - August 2009
Aptuit January 2006 - October 2008
sanofi-aventis October 2004 - December 2005
Aventis Pharmaceuticals 2001 - 2004
Hoechst Marion Roussel 1998 - 2001
Marion Merrell Dow 1992 - 1998
Skills
Validation, Computer System..., Quality Assurance, CAPA, Change Control, GxP, GAMP, GMP, cGMP, Pharmaceuticals, 21 CFR Part 11, Process Validation, Quality Systems, SOP, LIMS, Compliance, Documentation, Auditing, Document Management, Quality Auditing, Change Management, SDLC, SAP, FDA, Chromatography, ERP, Software Validation, Regulatory Requirements, HPLC, Analytical Chemistry, Software Documentation, Technical Writing, Automation, E-Learning, Microsoft Office, Project Management, Risk Assessment, Quality System, GLP, Trackwise, Sop, Pharmaceutical Industry, Biotechnology, Pharmaceutics, Regulatory Submissions, Technology Transfer, Regulatory Affairs, Biopharmaceuticals, Clinical Development, Cleaning Validation
Education
Baker University 1992 — 1994
Master, Business Administration
MidAmerica Nazarene University 1984 — 1988
BA, Chemistry
Training Courses
Boehringer Ingelheim Vetmedica March 2013 - Present
Boehringer Ingelheim Vetmedica October 2011 - March 2013
cGMP Validation, LLC March 2011 - October 2011
cGMP Validation, LLC October 2009 - March 2011
Aptuit October 2008 - August 2009
Aptuit January 2006 - October 2008
sanofi-aventis October 2004 - December 2005
Aventis Pharmaceuticals 2001 - 2004
Hoechst Marion Roussel 1998 - 2001
Marion Merrell Dow 1992 - 1998
Skills
Validation, Computer System..., Quality Assurance, CAPA, Change Control, GxP, GAMP, GMP, cGMP, Pharmaceuticals, 21 CFR Part 11, Process Validation, Quality Systems, SOP, LIMS, Compliance, Documentation, Auditing, Document Management, Quality Auditing, Change Management, SDLC, SAP, FDA, Chromatography, ERP, Software Validation, Regulatory Requirements, HPLC, Analytical Chemistry, Software Documentation, Technical Writing, Automation, E-Learning, Microsoft Office, Project Management, Risk Assessment, Quality System, GLP, Trackwise, Sop, Pharmaceutical Industry, Biotechnology, Pharmaceutics, Regulatory Submissions, Technology Transfer, Regulatory Affairs, Biopharmaceuticals, Clinical Development, Cleaning Validation
Education
Baker University 1992 — 1994
Master, Business Administration
MidAmerica Nazarene University 1984 — 1988
BA, Chemistry
Training Courses
Rick Loz's cGMP Validation LLC Experience February 2002 - April 2003
Job
Industry Telecommunications
Experience
Motorola January 2007 - Present
LSI 2003 - 2006
cGMP Validation LLC February 2002 - April 2003
Agere Systems January 1997 - February 2002
Lucent Technologies April 1995 - January 1997
United States Air Force January 1988 - March 1995
Education
California State University Dominguez Hills
MBA, Marketing, 3.9
Clarkson University 1983 — 1987
BSEE, Computer Systems Networking and Telecommunications
Columbia Engineering
MS, Wireless Telecommunications
Motorola January 2007 - Present
LSI 2003 - 2006
cGMP Validation LLC February 2002 - April 2003
Agere Systems January 1997 - February 2002
Lucent Technologies April 1995 - January 1997
United States Air Force January 1988 - March 1995
Education
California State University Dominguez Hills
MBA, Marketing, 3.9
Clarkson University 1983 — 1987
BSEE, Computer Systems Networking and Telecommunications
Columbia Engineering
MS, Wireless Telecommunications
Anne DeMartino's cGMP Validation LLC Experience June 2009 - May 2011
Job Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
Luitpold Pharmaceuticals March 2012 - Present
Contract Pharmacal Corp December 2010 - March 2012
cGMP Validation LLC June 2009 - May 2011
Bristol-Myers Squibb December 2007 - June 2009
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2005 - August 2007
Medarex January 2005 - June 2005
Johnson Controls August 2003 - August 2004
CSSC 2001 - 2003
Merck 2000 - 2001
Colgate Palmolive 1999 - 2000
Skills
Change Control, Validation, Process Improvement, GMP, CAPA, FDA, 21 CFR Part 11, Sop, Cleaning Validation, Quality System, Computer System..., Quality Assurance, Biopharmaceuticals, Pharmaceutical Industry, Biotechnology, Aseptic Processing, GAMP, Quality Control
Education
Stevens Institute of Technology
Engineer's Degree, Chemical Engineering
Luitpold Pharmaceuticals March 2012 - Present
Contract Pharmacal Corp December 2010 - March 2012
cGMP Validation LLC June 2009 - May 2011
Bristol-Myers Squibb December 2007 - June 2009
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company September 2005 - August 2007
Medarex January 2005 - June 2005
Johnson Controls August 2003 - August 2004
CSSC 2001 - 2003
Merck 2000 - 2001
Colgate Palmolive 1999 - 2000
Skills
Change Control, Validation, Process Improvement, GMP, CAPA, FDA, 21 CFR Part 11, Sop, Cleaning Validation, Quality System, Computer System..., Quality Assurance, Biopharmaceuticals, Pharmaceutical Industry, Biotechnology, Aseptic Processing, GAMP, Quality Control
Education
Stevens Institute of Technology
Engineer's Degree, Chemical Engineering
Jeff Cordero's cGMP Validation LLC Experience 2001 - 2002
Job Validation Engineer at Compliance Concepts, Inc
Industry Biotechnology
Experience
Compliance Concepts, Inc April 2015 - Present
Oxford International December 2014 - February 2015
University of Phoenix October 2013 - November 2014
USDM July 2013 - September 2013
Genentech, Inc. November 2005 - July 2013
Validation Technologies, VTI 2002 - 2004
cGMP Validation, LLC 2001 - 2002
Amgen 1997 - 2000
Biogen 1993 - 1995
Paragon Vision Sciences 1992 - 1993
Skills
Change Control, Validation, Sop, Aseptic Processing, Cleaning Validation, GMP, CAPA, Quality Control, Computer System..., Biotechnology, CIP, GLP, GxP, Aseptic Technique, Sterilization, Quality Assurance, V&V, FDA, Trackwise, Deviation Management, Biopharmaceuticals, Environmental Monitoring, Pharmaceutical Industry, Lyophilization, 21 CFR Part 11, FDA GMP, Regulatory Requirements, Quality System, Formulation, cGMP practices, Process Equipment, LIMS, Technology Transfer, Purification, Fermentation, Deviations, Chromatography, Vaccines, Analytical Method..., Filtration, Equipment Qualification, Validations, Steam, Documentum, SIP, Emerson DeltaV, cGMP, Pharmaceuticals, Quality Engineering, Facility Start-up
Education
University of Phoenix 2012 — 2014
Bachelor's Degree, Business-Project Management
Compliance Concepts, Inc April 2015 - Present
Oxford International December 2014 - February 2015
University of Phoenix October 2013 - November 2014
USDM July 2013 - September 2013
Genentech, Inc. November 2005 - July 2013
Validation Technologies, VTI 2002 - 2004
cGMP Validation, LLC 2001 - 2002
Amgen 1997 - 2000
Biogen 1993 - 1995
Paragon Vision Sciences 1992 - 1993
Skills
Change Control, Validation, Sop, Aseptic Processing, Cleaning Validation, GMP, CAPA, Quality Control, Computer System..., Biotechnology, CIP, GLP, GxP, Aseptic Technique, Sterilization, Quality Assurance, V&V, FDA, Trackwise, Deviation Management, Biopharmaceuticals, Environmental Monitoring, Pharmaceutical Industry, Lyophilization, 21 CFR Part 11, FDA GMP, Regulatory Requirements, Quality System, Formulation, cGMP practices, Process Equipment, LIMS, Technology Transfer, Purification, Fermentation, Deviations, Chromatography, Vaccines, Analytical Method..., Filtration, Equipment Qualification, Validations, Steam, Documentum, SIP, Emerson DeltaV, cGMP, Pharmaceuticals, Quality Engineering, Facility Start-up
Education
University of Phoenix 2012 — 2014
Bachelor's Degree, Business-Project Management
Jim Preslar's cGMP Validation LLC Experience April 2002 - November 2004
Job Software QA Manager at Synchronoss Technologies
Industry Information Technology and Services
Experience
Synchronoss Technologies February 2013 - Present
Synchronoss Technologies January 2011 - February 2013
Synchronoss Technologies April 2006 - December 2010
Hewitt Associates November 2004 - March 2006
cGMP Validation LLC April 2002 - November 2004
Skills
SDLC, Quality Assurance, Testing, Requirements Analysis, Bugzilla, SQL, Quality Center, Computer System..., 21 CFR Part 11, System Testing, Software Quality..., Software Development, XML, Test Planning, User Acceptance Testing, Analysis, Troubleshooting, Web Applications, Visio
Education
Penn State University 2000 — 2003
Information Sciences and Technology
Northampton Community College 1998 — 2000
A.S., Computer Information Systems and Technology
Synchronoss Technologies February 2013 - Present
Synchronoss Technologies January 2011 - February 2013
Synchronoss Technologies April 2006 - December 2010
Hewitt Associates November 2004 - March 2006
cGMP Validation LLC April 2002 - November 2004
Skills
SDLC, Quality Assurance, Testing, Requirements Analysis, Bugzilla, SQL, Quality Center, Computer System..., 21 CFR Part 11, System Testing, Software Quality..., Software Development, XML, Test Planning, User Acceptance Testing, Analysis, Troubleshooting, Web Applications, Visio
Education
Penn State University 2000 — 2003
Information Sciences and Technology
Northampton Community College 1998 — 2000
A.S., Computer Information Systems and Technology
Anjoe Anthonysamy's cGMP Validation LLC Experience September 2011 - March 2015
Job CSV Specialist at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions April 2015 - Present
cGMP Validation LLC. September 2011 - March 2015
Aptuit, Inc. July 2007 - September 2011
GE Transportation April 2005 - May 2007
Konica Minolta May 2000 - March 2005
Skills
Documentation, SDLC, Business Analysis, Compliance, Budgeting, Software Documentation, Process Improvement, Quality Assurance, Validation, Six Sigma, Computer System..., 21 CFR Part 11, GMP, Pharmaceutical Industry, Project Management, Budgets, Integration, Testing, PMP, Visio, LIMS, Vendor Management, Program Management, Business Intelligence, Change Control, Requirements Analysis
Education
University of South Alabama 1997 — 2000
Bachelor of Science
RIMA College 1994 — 1996
Diploma in Computer Science
Catalent Pharma Solutions April 2015 - Present
cGMP Validation LLC. September 2011 - March 2015
Aptuit, Inc. July 2007 - September 2011
GE Transportation April 2005 - May 2007
Konica Minolta May 2000 - March 2005
Skills
Documentation, SDLC, Business Analysis, Compliance, Budgeting, Software Documentation, Process Improvement, Quality Assurance, Validation, Six Sigma, Computer System..., 21 CFR Part 11, GMP, Pharmaceutical Industry, Project Management, Budgets, Integration, Testing, PMP, Visio, LIMS, Vendor Management, Program Management, Business Intelligence, Change Control, Requirements Analysis
Education
University of South Alabama 1997 — 2000
Bachelor of Science
RIMA College 1994 — 1996
Diploma in Computer Science
Todd Pavuk's cGMP Validation LLC Experience August 2012 - March 2013
Job Director of Engineering at ACell, Inc.
Industry Pharmaceuticals
Experience
ACell, Inc. March 2013 - Present
Vizia, Inc March 2012 - Present
cGMP Validation LLC August 2012 - March 2013
Alkermes September 2004 - July 2012
Integrated Project Services (IPS) November 2003 - September 2004
Human Genome Sciences March 1998 - November 2003
Chesapeake Biological Labs 1993 - 1998
GEA Niro A/S 1991 - 1993
Skills
Validation, GMP, FDA, Cell Culture, 21 CFR Part 11, Change Control, Regulatory Affairs, Continuous Improvement, Quality Control, Start-ups, Product Development, Software Documentation, Technology Transfer, Pharmaceutical Industry, CAPA, Quality System, Biopharmaceuticals, Project Management, Quality Management, Quality Assurance, Trackwise, Biotechnology, Cross-functional Team..., V&V, Quality Auditing, Clinical Trials, Cleaning Validation, Sop, Process Engineering, Regulatory Submissions, Aseptic Processing, Computer System..., Regulatory Requirements, Medical Devices
Education
University of Warwick - Warwick Business School 2010 — 2013
MBA, Business
Pennsylvania State University-Erie Campus 1988 — 1990
BS, Electrical Engineering Technology
Mt Pleasant Area HS
Mt Pleasant Area HS
Mt Pleasant Area HS
ACell, Inc. March 2013 - Present
Vizia, Inc March 2012 - Present
cGMP Validation LLC August 2012 - March 2013
Alkermes September 2004 - July 2012
Integrated Project Services (IPS) November 2003 - September 2004
Human Genome Sciences March 1998 - November 2003
Chesapeake Biological Labs 1993 - 1998
GEA Niro A/S 1991 - 1993
Skills
Validation, GMP, FDA, Cell Culture, 21 CFR Part 11, Change Control, Regulatory Affairs, Continuous Improvement, Quality Control, Start-ups, Product Development, Software Documentation, Technology Transfer, Pharmaceutical Industry, CAPA, Quality System, Biopharmaceuticals, Project Management, Quality Management, Quality Assurance, Trackwise, Biotechnology, Cross-functional Team..., V&V, Quality Auditing, Clinical Trials, Cleaning Validation, Sop, Process Engineering, Regulatory Submissions, Aseptic Processing, Computer System..., Regulatory Requirements, Medical Devices
Education
University of Warwick - Warwick Business School 2010 — 2013
MBA, Business
Pennsylvania State University-Erie Campus 1988 — 1990
BS, Electrical Engineering Technology
Mt Pleasant Area HS
Mt Pleasant Area HS
Mt Pleasant Area HS
Zachary Sparks's cGMP Validation LLC Experience September 2007 - Present
Job Validation Specialist at cGMP Validation LLC
Industry Pharmaceuticals
Experience
cGMP Validation LLC September 2007 - Present
Tolmar Inc. December 2002 - July 2007
Skills
Validation, GMP, CAPA, Documentation, SOP, Quality Assurance, Environmental Monitoring, Commissioning, Technical Writing, Microbiology, cGMP, Sop, Aseptic Processing, 21 CFR Part 11, GxP, Cleaning Validation, Change Control
Education
Colorado State University 1994 — 1999
Bachelor of Science, Microbiology
cGMP Validation LLC September 2007 - Present
Tolmar Inc. December 2002 - July 2007
Skills
Validation, GMP, CAPA, Documentation, SOP, Quality Assurance, Environmental Monitoring, Commissioning, Technical Writing, Microbiology, cGMP, Sop, Aseptic Processing, 21 CFR Part 11, GxP, Cleaning Validation, Change Control
Education
Colorado State University 1994 — 1999
Bachelor of Science, Microbiology
Laura Gillikin's cGMP Validation LLC Experience March 2000 - Present
Job Vice President at cGMP Validation, LLC
Industry Pharmaceuticals
Experience
cGMP Validation, LLC March 2000 - Present
Bayer HealthCare 1998 - 2000
Burroughs Wellcome Co. 1987 - 1994
Skills
Pharmaceutical Industry, Validation, Lifesciences, GMP, Biopharmaceuticals, HPLC, Technology Transfer, V&V, Regulatory Submissions, 21 CFR Part 11, Medical Devices, Change Control, Sop, Pharmaceutics, FDA, GLP, CAPA, Quality System, Regulatory Affairs, ISO 13485, Biotechnology, Regulatory Requirements, Computer System..., SOP, Analytical Chemistry
Education
East Carolina University 1985 — 1988
BS, Molecular Biology
cGMP Validation, LLC March 2000 - Present
Bayer HealthCare 1998 - 2000
Burroughs Wellcome Co. 1987 - 1994
Skills
Pharmaceutical Industry, Validation, Lifesciences, GMP, Biopharmaceuticals, HPLC, Technology Transfer, V&V, Regulatory Submissions, 21 CFR Part 11, Medical Devices, Change Control, Sop, Pharmaceutics, FDA, GLP, CAPA, Quality System, Regulatory Affairs, ISO 13485, Biotechnology, Regulatory Requirements, Computer System..., SOP, Analytical Chemistry
Education
East Carolina University 1985 — 1988
BS, Molecular Biology
Sabrina Moore's cGMP Validation LLC Experience 2003 - 2006
Job Sr. Validation Engineer
Industry Medical Devices
Experience
CIBA Vision September 2009 - Present
Talecris Biotherapeutics 2007 - 2009
cGMP Validation LLC 2003 - 2006
Education
Campbell University 1998 — 2002
B.S., Pharmaceutical Science
North Carolina State University 1994 — 1996
CIBA Vision September 2009 - Present
Talecris Biotherapeutics 2007 - 2009
cGMP Validation LLC 2003 - 2006
Education
Campbell University 1998 — 2002
B.S., Pharmaceutical Science
North Carolina State University 1994 — 1996
Jim Mrowca's cGMP Validation LLC Experience 2002 - 2003
Job Senior Electrical Engineer at LTS Scale, LLC
Industry Machinery
Experience
LTS Scale, LLC August 2015 - Present
STERIS Corporation August 2012 - April 2015
STAR Dynamics June 2011 - February 2012
Lockheed Martin November 2004 - May 2009
cGMP Validation LLC 2002 - 2003
Agere Systems September 1999 - December 2001
IBM October 1997 - September 1999
Texas Instruments November 1990 - September 1997
Texas Instruments DSEG June 1982 - November 1990
Skills
Embedded Systems, FPGA, ASIC, Systems Engineering, Simulations, Integrated Circuit..., R&D, Embedded Software, Firmware, Digital Signal..., Electrical Engineering, Hardware Architecture, Analog, VHDL, Debugging, Semiconductors, Hardware, Automation, Microcontrollers, Electronics, Validation, EDA, Digital Signal..., RF, Circuit Design, Verilog, Engineering Management, Sensors, Computer System..., Digital Circuit Design, Xilinx, IC, RTOS, Digital IC Design, 21 CFR Part 11, Cross-functional..., PCB Design
Education
Illinois Institute of Technology 1978 — 1982
BS, Electrical Engineering
LTS Scale, LLC August 2015 - Present
STERIS Corporation August 2012 - April 2015
STAR Dynamics June 2011 - February 2012
Lockheed Martin November 2004 - May 2009
cGMP Validation LLC 2002 - 2003
Agere Systems September 1999 - December 2001
IBM October 1997 - September 1999
Texas Instruments November 1990 - September 1997
Texas Instruments DSEG June 1982 - November 1990
Skills
Embedded Systems, FPGA, ASIC, Systems Engineering, Simulations, Integrated Circuit..., R&D, Embedded Software, Firmware, Digital Signal..., Electrical Engineering, Hardware Architecture, Analog, VHDL, Debugging, Semiconductors, Hardware, Automation, Microcontrollers, Electronics, Validation, EDA, Digital Signal..., RF, Circuit Design, Verilog, Engineering Management, Sensors, Computer System..., Digital Circuit Design, Xilinx, IC, RTOS, Digital IC Design, 21 CFR Part 11, Cross-functional..., PCB Design
Education
Illinois Institute of Technology 1978 — 1982
BS, Electrical Engineering
Jill DiGiovanni's cGMP Validation LLC Experience 2002 - 2005
Job
Industry Pharmaceuticals
Experience
Fishawack Communications March 2011 - June 2014
AlphaBioCom April 2008 - May 2010
Ethos Health Communications June 2006 - April 2008
cGMP Validation LLC 2002 - 2005
Skills
Medical Education, Medical Writing, Pharmaceutical Industry, Neurology, Dermatology, CME, Pharmaceutical Sales, Healthcare, New Business Development, CRM, Infectious Diseases, Project Planning, Oncology, Advisory Boards
Education
Loyola University Maryland 1994 — 1998
BA, Journalism
The Baldwin School
Fishawack Communications March 2011 - June 2014
AlphaBioCom April 2008 - May 2010
Ethos Health Communications June 2006 - April 2008
cGMP Validation LLC 2002 - 2005
Skills
Medical Education, Medical Writing, Pharmaceutical Industry, Neurology, Dermatology, CME, Pharmaceutical Sales, Healthcare, New Business Development, CRM, Infectious Diseases, Project Planning, Oncology, Advisory Boards
Education
Loyola University Maryland 1994 — 1998
BA, Journalism
The Baldwin School
Galen Lapka's cGMP Validation LLC Experience 2001 - Present
Job Validation Specialist at cGMP Validation LLC
Industry Pharmaceuticals
Experience
cGMP Validation LLC 2001 - Present
Viral Antigens Inc. 2000 - 2004
St. Jude Children's Research Hospital 1997 - 2000
Schering-Plough 1983 - 1997
Skills
Computer System..., Quality Management, Lifesciences, Cleaning Validation, Analytical Chemistry, Software Documentation, Document Management, Technology Transfer, Biotechnology, Medical Devices, HPLC, Pharmaceutics, GLP, ISO, Regulatory Affairs, Life Sciences, 21 CFR Part 11
Education
McKendree University
Bachelor of Applied Science (B.A.Sc.), Biology, General
cGMP Validation LLC 2001 - Present
Viral Antigens Inc. 2000 - 2004
St. Jude Children's Research Hospital 1997 - 2000
Schering-Plough 1983 - 1997
Skills
Computer System..., Quality Management, Lifesciences, Cleaning Validation, Analytical Chemistry, Software Documentation, Document Management, Technology Transfer, Biotechnology, Medical Devices, HPLC, Pharmaceutics, GLP, ISO, Regulatory Affairs, Life Sciences, 21 CFR Part 11
Education
McKendree University
Bachelor of Applied Science (B.A.Sc.), Biology, General
Rebecca Santorios's cGMP Validation LLC Experience August 2009 - June 2012
Job Assoc.Director of Compliance, Health and Life Sciences at Sidus BioData
Industry Pharmaceuticals
Experience
Sidus BioData October 2014 - Present
BioReliance October 2013 - October 2014
QIAGEN April 2012 - October 2013
cGMP Validation LLC August 2009 - June 2012
CEL-SCI July 1999 - August 2009
Skills
Equipment Validation, Software Validation, Quality Systems, Medical Devices, cGMP, FDA, Technical Writing, Pharmaceuticals, IEC 62304, ISO 14385, ISO 14971, 21 CFR 820, 21 CFR 210, 21 CFR 211, Risk Management, Aseptic Processing, Biopharmaceuticals, 21 CFR Part 11, Process Validation, Equipment Qualification, Requirements Analysis, V&V, Validation, 21 CFR, ISO, GMP, Quality System, Change Control, Computer System..., Testing, GxP, GAMP, ISO 13485, Design Control, Quality Assurance, Regulatory Requirements, FDA GMP, CAPA, Pharmaceutical Industry, Sop, LIMS, GLP, Cleaning Validation, Software Quality..., cGMP practices, Technology Transfer, Quality Control, Biotechnology, Quality Auditing, SDLC
Education
University of Florida
Post-graduate Certificate, Systems Engineering
University of Maryland College Park
BS, Chemical Engineering - Specialization in Biochemical Engineering
Sidus BioData October 2014 - Present
BioReliance October 2013 - October 2014
QIAGEN April 2012 - October 2013
cGMP Validation LLC August 2009 - June 2012
CEL-SCI July 1999 - August 2009
Skills
Equipment Validation, Software Validation, Quality Systems, Medical Devices, cGMP, FDA, Technical Writing, Pharmaceuticals, IEC 62304, ISO 14385, ISO 14971, 21 CFR 820, 21 CFR 210, 21 CFR 211, Risk Management, Aseptic Processing, Biopharmaceuticals, 21 CFR Part 11, Process Validation, Equipment Qualification, Requirements Analysis, V&V, Validation, 21 CFR, ISO, GMP, Quality System, Change Control, Computer System..., Testing, GxP, GAMP, ISO 13485, Design Control, Quality Assurance, Regulatory Requirements, FDA GMP, CAPA, Pharmaceutical Industry, Sop, LIMS, GLP, Cleaning Validation, Software Quality..., cGMP practices, Technology Transfer, Quality Control, Biotechnology, Quality Auditing, SDLC
Education
University of Florida
Post-graduate Certificate, Systems Engineering
University of Maryland College Park
BS, Chemical Engineering - Specialization in Biochemical Engineering
Brett Coombs's cGMP Validation LLC Experience January 2000 - November 2000
Job Director of Operations at Swagelok Kansas City
Industry Biotechnology
Experience
Swagelok Kansas City 2000 - Present
cGMP Validation LLC January 2000 - November 2000
Chemsyn Science Laboratories December 1987 - December 1999
Skills
Operations Management, Strategic Planning, Microsoft Office, Lean Manufacturing, Six Sigma, Manufacturing, Process Improvement, Continuous Improvement, Customer Service, Microsoft Excel, Project Management, New Business Development, Sales, Leadership
Education
The University of Kansas 1983 — 1987
Bachelor of Science (BS), Biochemistry, Chemistry
Swagelok Kansas City 2000 - Present
cGMP Validation LLC January 2000 - November 2000
Chemsyn Science Laboratories December 1987 - December 1999
Skills
Operations Management, Strategic Planning, Microsoft Office, Lean Manufacturing, Six Sigma, Manufacturing, Process Improvement, Continuous Improvement, Customer Service, Microsoft Excel, Project Management, New Business Development, Sales, Leadership
Education
The University of Kansas 1983 — 1987
Bachelor of Science (BS), Biochemistry, Chemistry
Charles Krouse's cGMP Validation LLC Experience August 2008 - Present
Job Validation Specialist at cGMP Validation, LLC
Industry Pharmaceuticals
Experience
cGMP Validation, LLC August 2008 - Present
NOAA National Ocean Service May 1974 - December 2007
Skills
Validation, CAPA, Software Documentation, Biotechnology, 21 CFR Part 11, Computer System..., Change Control, FDA, GxP, GLP, Cleaning Validation, Sop, Quality System, GMP, GAMP, V&V, SOP
Education
East Carolina University 1970 — 1974
B.S., Biology
cGMP Validation, LLC August 2008 - Present
NOAA National Ocean Service May 1974 - December 2007
Skills
Validation, CAPA, Software Documentation, Biotechnology, 21 CFR Part 11, Computer System..., Change Control, FDA, GxP, GLP, Cleaning Validation, Sop, Quality System, GMP, GAMP, V&V, SOP
Education
East Carolina University 1970 — 1974
B.S., Biology
Sarah Lamiano's cGMP Validation LLC Experience January 2012 - Present
Job Validation Engineer at Canon BioMedical, Inc.
Industry Biotechnology
Experience
Canon BioMedical, Inc. June 2015 - Present
cGMP Validation LLC January 2012 - Present
QIAGEN May 2014 - June 2015
QIAGEN July 2011 - December 2011
BYK-Gardner USA March 2011 - July 2011
Albin O. Kuhn Library September 2006 - May 2010
Old Navy of Columbia May 2006 - November 2007
Skills
Software Documentation, Testing, FDA, Validation, ISO 14971, Automation, ISO 13485, Engineering, 21 CFR Part 11, V&V, Product Development, Computer System..., Change Control, Medical Devices, CAPA, GMP, ISO, Sop, Quality System, Quality Assurance, Design Control, Lifesciences, Biotechnology, Root Cause Analysis, GLP, Quality Auditing, Pharmaceutical Industry, GAMP, GxP, Laboratory Automation, Clean Rooms, Regulatory Requirements, LIMS, Life Sciences
Education
University of Maryland Baltimore County 2006 — 2010
Bachelor of Science, Physics
Canon BioMedical, Inc. June 2015 - Present
cGMP Validation LLC January 2012 - Present
QIAGEN May 2014 - June 2015
QIAGEN July 2011 - December 2011
BYK-Gardner USA March 2011 - July 2011
Albin O. Kuhn Library September 2006 - May 2010
Old Navy of Columbia May 2006 - November 2007
Skills
Software Documentation, Testing, FDA, Validation, ISO 14971, Automation, ISO 13485, Engineering, 21 CFR Part 11, V&V, Product Development, Computer System..., Change Control, Medical Devices, CAPA, GMP, ISO, Sop, Quality System, Quality Assurance, Design Control, Lifesciences, Biotechnology, Root Cause Analysis, GLP, Quality Auditing, Pharmaceutical Industry, GAMP, GxP, Laboratory Automation, Clean Rooms, Regulatory Requirements, LIMS, Life Sciences
Education
University of Maryland Baltimore County 2006 — 2010
Bachelor of Science, Physics
Arthur Bradford's cGMP Validation LLC Experience 2006 - 2011
Job Arthur James( Jim) Bradford
Industry Military
Experience
PharmEng Technology March 2012 - Present
cGMP Validation LLC 2006 - 2011
Sanofi 1995 - 2006
US Navy Retired 1964 - 1994
Skills
Customer Service, Microsoft Excel, Microsoft Office, Microsoft Word, Validation, Manufacturing, Commissioning, HVAC, Steam, Biotechnology, V&V, Pharmaceutical Industry, Computer System..., GMP, 21 CFR Part 11, Quality Assurance, FDA, Change Control
Education
MidAmerica Nazarene University 1998 — 1999
Management of Human Resources
PharmEng Technology March 2012 - Present
cGMP Validation LLC 2006 - 2011
Sanofi 1995 - 2006
US Navy Retired 1964 - 1994
Skills
Customer Service, Microsoft Excel, Microsoft Office, Microsoft Word, Validation, Manufacturing, Commissioning, HVAC, Steam, Biotechnology, V&V, Pharmaceutical Industry, Computer System..., GMP, 21 CFR Part 11, Quality Assurance, FDA, Change Control
Education
MidAmerica Nazarene University 1998 — 1999
Management of Human Resources
Joe Giampetro's cGMP Validation LLC Experience 2000 - 2007
Job MANUFACTURING MANAGER/PROJECT MANAGER/PLANT MANAGER Leading highly effective teams in a manufacturing environment
Industry Medical Devices
Experience
Molnlycke Health Care 2007 - 2015
Mölnlycke Health Care 2007 - 2014
cGMP Validation, LLC 2000 - 2007
Inolex Chemical Company 1990 - 2000
Skills
Manufacturing, Leadership, Team Building, Medical Devices, GMP, Quality System, ISO 13485, FDA, Validation, CAPA, Lean Manufacturing, mentoring, Process Improvement, Customer Relations, Cross-functional Team..., Process Efficiency, Manufacturing..., Operational Efficiency, Industrial Safety, Continuous Improvement, Environmental Health
Education
Belmont Abbey College
BS Chemistry, Biology Minor
Molnlycke Health Care 2007 - 2015
Mölnlycke Health Care 2007 - 2014
cGMP Validation, LLC 2000 - 2007
Inolex Chemical Company 1990 - 2000
Skills
Manufacturing, Leadership, Team Building, Medical Devices, GMP, Quality System, ISO 13485, FDA, Validation, CAPA, Lean Manufacturing, mentoring, Process Improvement, Customer Relations, Cross-functional Team..., Process Efficiency, Manufacturing..., Operational Efficiency, Industrial Safety, Continuous Improvement, Environmental Health
Education
Belmont Abbey College
BS Chemistry, Biology Minor
Djonaldo Misa's cGMP Validation LLC Experience December 2003 - December 2007
Job Validation / Quality Assurance
Industry Biotechnology
Experience
Validation Technologies, Inc. April 2012 - Present
N/A November 2011 - March 2012
Dendreon April 2011 - November 2011
ValSource, LLC January 2009 - April 2011
N/A January 2008 - December 2008
cGMP Validation LLC December 2003 - December 2007
Skills
Change Control, FDA, Biopharmaceuticals, GAMP, Validation, 21 CFR Part 11, GMP
Education
Rutgers, The State University of New Jersey-New Brunswick
Bachelor's degree
Validation Technologies, Inc. April 2012 - Present
N/A November 2011 - March 2012
Dendreon April 2011 - November 2011
ValSource, LLC January 2009 - April 2011
N/A January 2008 - December 2008
cGMP Validation LLC December 2003 - December 2007
Skills
Change Control, FDA, Biopharmaceuticals, GAMP, Validation, 21 CFR Part 11, GMP
Education
Rutgers, The State University of New Jersey-New Brunswick
Bachelor's degree