ProPharma Group
Industry: Company
DescriptionFounded: 2001 Subsidiaries: PI Arm, SOLUTIONS in Health Inc., Xendo Holding B.V.
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ProPharma Group Employees
Employee
Years
Job
Industry
Megan Bertheaume Megan Bertheaume's ProPharma Group Experience June 2015 - Present
Job Client Services Coordinator at ProPharma Group
Industry Hospital & Health Care
Experience
ProPharma Group June 2015 - Present
Universal Hospital Services December 2014 - June 2015
Universal Hospital Services July 2014 - December 2014
Universal Hospital Services November 2012 - July 2014
Universal Hospital Services July 2012 - November 2012
Essentia March 2012 - May 2012
Skills
Hospitals, Healthcare, Customer Service, Public Speaking, Event Planning, PowerPoint
Education
University of Minnesota-Duluth 2008 — 2012
Bachelor of Science (BS), Health/Health Care Administration/Management
MGSH
MGSH
ProPharma Group June 2015 - Present
Universal Hospital Services December 2014 - June 2015
Universal Hospital Services July 2014 - December 2014
Universal Hospital Services November 2012 - July 2014
Universal Hospital Services July 2012 - November 2012
Essentia March 2012 - May 2012
Skills
Hospitals, Healthcare, Customer Service, Public Speaking, Event Planning, PowerPoint
Education
University of Minnesota-Duluth 2008 — 2012
Bachelor of Science (BS), Health/Health Care Administration/Management
MGSH
MGSH
Richard MacDonald Richard MacDonald's ProPharma Group Experience March 2014 - June 2014
Job Validation Engineer with Validant contracted to Meridian/Pfizer in St. Louis, Mo
Industry Pharmaceuticals
Experience
Validant July 2014 - Present
ProPharma Group March 2014 - June 2014
ProPharma Group October 2012 - January 2014
Novartis February 2012 - October 2012
ProPharma Group August 2011 - December 2011
ProPharma Group September 2010 - June 2011
ProPharma Group June 2010 - August 2010
Novartis Vaccines and Diagnostics July 2009 - February 2010
Pfizer 2006 - 2008
Pfizer August 1987 - December 2006
Skills
Validation, Process Validation, Technology Transfer, Manufacturing, Aseptic Processing, Biopharmaceuticals, V&V, Sop, Root Cause Analysis, Pharmaceutics, Change Control, GMP, CAPA, FDA, GAMP, GxP, Computer System..., 21 CFR Part 11, Quality System, Pharmaceutical Industry, Quality Auditing, Testing, Sterilization, Regulatory Requirements, LIMS, ISO 13485, Quality Control, GLP, Quality Assurance, Cleaning Validation, Calibration, Biotechnology, Regulatory Affairs, Medical Devices, Vaccines, Process Simulation, Quality Management, Lifesciences, R&D, Trackwise, Microbiology, ISO, Design of Experiments, Software Documentation, Six Sigma, Process Improvement, Continuous Improvement, Document Management, Process Engineering, TrackWise
Education
University of Phoenix
BSBM, Management
Validant July 2014 - Present
ProPharma Group March 2014 - June 2014
ProPharma Group October 2012 - January 2014
Novartis February 2012 - October 2012
ProPharma Group August 2011 - December 2011
ProPharma Group September 2010 - June 2011
ProPharma Group June 2010 - August 2010
Novartis Vaccines and Diagnostics July 2009 - February 2010
Pfizer 2006 - 2008
Pfizer August 1987 - December 2006
Skills
Validation, Process Validation, Technology Transfer, Manufacturing, Aseptic Processing, Biopharmaceuticals, V&V, Sop, Root Cause Analysis, Pharmaceutics, Change Control, GMP, CAPA, FDA, GAMP, GxP, Computer System..., 21 CFR Part 11, Quality System, Pharmaceutical Industry, Quality Auditing, Testing, Sterilization, Regulatory Requirements, LIMS, ISO 13485, Quality Control, GLP, Quality Assurance, Cleaning Validation, Calibration, Biotechnology, Regulatory Affairs, Medical Devices, Vaccines, Process Simulation, Quality Management, Lifesciences, R&D, Trackwise, Microbiology, ISO, Design of Experiments, Software Documentation, Six Sigma, Process Improvement, Continuous Improvement, Document Management, Process Engineering, TrackWise
Education
University of Phoenix
BSBM, Management
Alfredo Canhoto Alfredo Canhoto's ProPharma Group Experience November 2012 - Present
Job Associate Director of Technical Solutions at ProPharma Group | Cleaning & Process Validation SME | Author | Speaker
Industry Biotechnology
Experience
ProPharma Group November 2012 - Present
ProPharma Group July 2012 - Present
Genzyme 2007 - July 2012
Wyeth Biopharma 2002 - 2007
Wyeth Biotech 2002 - 2007
UMass Biologics Laboratory 2000 - 2002
Skills
GMP, Validation, Cleaning Validation, cGMP, Aseptic Processing, Process Validation, Quality Systems, CAPA, Biotechnology, SOP, Change Control, Cell Culture, FDA, Vaccines, Purification, Root Cause Analysis, Quality Assurance, Document Management, QC, Commissioning, Sop, 21 CFR Part 11, V&V, Quality System, Technology Transfer, Quality Control, Pharmaceutical Industry, Manufacturing, GxP, Laboratory, Computer System..., GAMP, Biopharmaceuticals, Software Documentation, LIMS, Chromatography, Trackwise, GLP, Cross-functional Team..., TrackWise
Education
Dana-Farber Cancer Institute; Harvard Medical School 1998 — 2000
Post Doctoral Fellowship, Cell/Cellular and Molecular Biology
University of South Carolina-Columbia 1992 — 1997
Ph.D., BioChemistry
University of Massachusetts, Amherst 1988 — 1992
BS, BioChemistry
ProPharma Group November 2012 - Present
ProPharma Group July 2012 - Present
Genzyme 2007 - July 2012
Wyeth Biopharma 2002 - 2007
Wyeth Biotech 2002 - 2007
UMass Biologics Laboratory 2000 - 2002
Skills
GMP, Validation, Cleaning Validation, cGMP, Aseptic Processing, Process Validation, Quality Systems, CAPA, Biotechnology, SOP, Change Control, Cell Culture, FDA, Vaccines, Purification, Root Cause Analysis, Quality Assurance, Document Management, QC, Commissioning, Sop, 21 CFR Part 11, V&V, Quality System, Technology Transfer, Quality Control, Pharmaceutical Industry, Manufacturing, GxP, Laboratory, Computer System..., GAMP, Biopharmaceuticals, Software Documentation, LIMS, Chromatography, Trackwise, GLP, Cross-functional Team..., TrackWise
Education
Dana-Farber Cancer Institute; Harvard Medical School 1998 — 2000
Post Doctoral Fellowship, Cell/Cellular and Molecular Biology
University of South Carolina-Columbia 1992 — 1997
Ph.D., BioChemistry
University of Massachusetts, Amherst 1988 — 1992
BS, BioChemistry
RICARDO Torres-Rivera RICARDO Torres-Rivera's ProPharma Group Experience March 2014 - Present
Job CSV Consultant at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group March 2014 - Present
Compli, LLC June 2013 - December 2013
Independent Consultant: IT Management March 2006 - June 2013
NSHMBA 2003 - 2008
Eli Lilly and Company September 1999 - August 2005
Skills
Program Management, SDLC, SharePoint, Team Leadership, Business Analysis, Project Management, ITIL v3 Foundations..., ITIL Service Strategy, EHS Management Systems, Software Design, Strategic Communications, Document Management, SOP development, Database Design, Economic Development, Technological Innovation, Technology Transfer, GIS systems, Business Workflows, Technology Roadmapping, Technology Needs..., Instructor-led Training, SWOT analysis, Persuasive Presentations, Business Intelligence..., Change Management, Technical Support, Customer Service, IT Project Leadership, Root Cause Analysis, Deviation Management, Computer System..., 21 CFR Part 11, Risk Assessment, Test Management, IT Audit, Databases, Governance, Testing, Validation, Visio
Education
University of Puerto Rico-Rio Piedras 1995 — 1999
Bachelor of Business Administration (BBA), Management Information Systems, General
University of Puerto Rico-Rio Piedras
Master in Planning, Development Economics and International Development
ProPharma Group March 2014 - Present
Compli, LLC June 2013 - December 2013
Independent Consultant: IT Management March 2006 - June 2013
NSHMBA 2003 - 2008
Eli Lilly and Company September 1999 - August 2005
Skills
Program Management, SDLC, SharePoint, Team Leadership, Business Analysis, Project Management, ITIL v3 Foundations..., ITIL Service Strategy, EHS Management Systems, Software Design, Strategic Communications, Document Management, SOP development, Database Design, Economic Development, Technological Innovation, Technology Transfer, GIS systems, Business Workflows, Technology Roadmapping, Technology Needs..., Instructor-led Training, SWOT analysis, Persuasive Presentations, Business Intelligence..., Change Management, Technical Support, Customer Service, IT Project Leadership, Root Cause Analysis, Deviation Management, Computer System..., 21 CFR Part 11, Risk Assessment, Test Management, IT Audit, Databases, Governance, Testing, Validation, Visio
Education
University of Puerto Rico-Rio Piedras 1995 — 1999
Bachelor of Business Administration (BBA), Management Information Systems, General
University of Puerto Rico-Rio Piedras
Master in Planning, Development Economics and International Development
Laura Fontan Laura Fontan's ProPharma Group Experience August 2011 - November 2011
Job Consumer Safety Officer at FDA
Industry Biotechnology
Experience
FDA July 2014 - Present
Meridian BioGroup LLC April 2014 - July 2014
Wellstat Diagnostics February 2014 - April 2014
MedImmune November 2011 - December 2013
ProPharma Group August 2011 - November 2011
Private Consultant March 2011 - June 2011
Intercell USA September 2009 - March 2011
Alcon Laboratories, Inc. June 2009 - September 2009
Human Genome Sciences Inc May 2003 - April 2009
Genentech Inc April 1994 - May 2003
Skills
FDA, Validation, CAPA, GMP, Quality Assurance, Sop, Team Building, Quality System, Change Management, Change Control, Continuous Improvement, Cleaning Validation
Education
MBA University of Phoenix 2001 — 2003
MBA, Businesss
University of California, Santa Cruz 1979 — 1983
BS, Biology
Montgomery Works workshop
FDA July 2014 - Present
Meridian BioGroup LLC April 2014 - July 2014
Wellstat Diagnostics February 2014 - April 2014
MedImmune November 2011 - December 2013
ProPharma Group August 2011 - November 2011
Private Consultant March 2011 - June 2011
Intercell USA September 2009 - March 2011
Alcon Laboratories, Inc. June 2009 - September 2009
Human Genome Sciences Inc May 2003 - April 2009
Genentech Inc April 1994 - May 2003
Skills
FDA, Validation, CAPA, GMP, Quality Assurance, Sop, Team Building, Quality System, Change Management, Change Control, Continuous Improvement, Cleaning Validation
Education
MBA University of Phoenix 2001 — 2003
MBA, Businesss
University of California, Santa Cruz 1979 — 1983
BS, Biology
Montgomery Works workshop
Phil Boncer Phil Boncer's ProPharma Group Experience 2010 - 2011
Job Validation and Engineering Consultant at P Boncer Consulting; available for projects at this time
Industry Pharmaceuticals
Experience
P Boncer Consulting December 2013 - Present
Shire Pharmaceuticals January 2013 - December 2013
P Boncer Consulting May 1999 - December 2012
PSC Biotech 2011 - 2012
ProPharma Group 2010 - 2011
ISPE 2002 - 2006
Alliance Pharmaceuticals January 1992 - April 1999
Skills
European Union, Analytical Chemistry, Pharmaceutical Industry, Validation, Medical Devices, Environmental Monitoring, Engineering, Sop, Technology Transfer, Pharmaceutics, Quality Assurance, GMP, FDA, 21 CFR Part 11, Regulatory Affairs, ISO 13485, Quality System, CAPA, Aseptic Processing, Lifesciences, Clinical Trials, R&D, Biopharmaceuticals, Computer System..., GAMP, LIMS, Root Cause Analysis, Vaccines, Cleaning Validation, GxP, V&V, Change Control, Chromatography, Quality Auditing, Design Control, Process Engineering, Document Management, HPLC, Quality Control, Microbiology, Biotechnology, Regulatory Submissions, Manufacturing, Quality Management, Cross-functional Team..., Process Simulation, Regulatory Requirements, GLP, GCP, SOP
Education
University of California, Santa Barbara 1981 — 1986
BA, Geology
P Boncer Consulting December 2013 - Present
Shire Pharmaceuticals January 2013 - December 2013
P Boncer Consulting May 1999 - December 2012
PSC Biotech 2011 - 2012
ProPharma Group 2010 - 2011
ISPE 2002 - 2006
Alliance Pharmaceuticals January 1992 - April 1999
Skills
European Union, Analytical Chemistry, Pharmaceutical Industry, Validation, Medical Devices, Environmental Monitoring, Engineering, Sop, Technology Transfer, Pharmaceutics, Quality Assurance, GMP, FDA, 21 CFR Part 11, Regulatory Affairs, ISO 13485, Quality System, CAPA, Aseptic Processing, Lifesciences, Clinical Trials, R&D, Biopharmaceuticals, Computer System..., GAMP, LIMS, Root Cause Analysis, Vaccines, Cleaning Validation, GxP, V&V, Change Control, Chromatography, Quality Auditing, Design Control, Process Engineering, Document Management, HPLC, Quality Control, Microbiology, Biotechnology, Regulatory Submissions, Manufacturing, Quality Management, Cross-functional Team..., Process Simulation, Regulatory Requirements, GLP, GCP, SOP
Education
University of California, Santa Barbara 1981 — 1986
BA, Geology
Fred Bickel Fred Bickel's ProPharma Group Experience November 2011 - August 2012
Job Vice President ProPharma Group | Risk Management | Commissioning | Qualification | Validation | Speaker
Industry Pharmaceuticals
Experience
ProPharma Group, Inc August 2012 - Present
ProPharma Group November 2011 - August 2012
ProPharma Group January 2011 - January 2012
ProPharma Group January 2009 - January 2011
KV Pharmaceutical Company October 2004 - January 2009
Kineticon Group, Inc. June 1995 - October 2004
Honeywell 1995 - 2004
Skills
Six Sigma, Manufacturing, Quality System, Validation, FDA, GMP, Lean Manufacturing, Commissioning, Process Improvement, Pharmaceutical Industry, Quality Auditing, Leadership, Quality Assurance, Product Development, Project Management, V&V, Management, Biotechnology, Change Management, Quality Control, Continuous Improvement, Negotiation, Medical Devices, CAPA, 21 CFR Part 11, Change Control, Engineering, Risk Management, Sop, Aseptic Processing, Strategy, GxP, ISO 13485, Biopharmaceuticals, Technology Transfer, Computer System..., Regulatory Requirements, Vaccines, Pharmaceutics, GAMP, Cleaning Validation, Trackwise, Process Simulation, LIMS, Cross-functional Team..., Regulatory Affairs, Quality Management, GLP, Contract Manufacturing, Regulatory Submissions
Education
University of Evansville 1970 — 1976
ProPharma Group, Inc August 2012 - Present
ProPharma Group November 2011 - August 2012
ProPharma Group January 2011 - January 2012
ProPharma Group January 2009 - January 2011
KV Pharmaceutical Company October 2004 - January 2009
Kineticon Group, Inc. June 1995 - October 2004
Honeywell 1995 - 2004
Skills
Six Sigma, Manufacturing, Quality System, Validation, FDA, GMP, Lean Manufacturing, Commissioning, Process Improvement, Pharmaceutical Industry, Quality Auditing, Leadership, Quality Assurance, Product Development, Project Management, V&V, Management, Biotechnology, Change Management, Quality Control, Continuous Improvement, Negotiation, Medical Devices, CAPA, 21 CFR Part 11, Change Control, Engineering, Risk Management, Sop, Aseptic Processing, Strategy, GxP, ISO 13485, Biopharmaceuticals, Technology Transfer, Computer System..., Regulatory Requirements, Vaccines, Pharmaceutics, GAMP, Cleaning Validation, Trackwise, Process Simulation, LIMS, Cross-functional Team..., Regulatory Affairs, Quality Management, GLP, Contract Manufacturing, Regulatory Submissions
Education
University of Evansville 1970 — 1976
Mario Mas-Nieves Mario Mas-Nieves's ProPharma Group Experience March 2012 - August 2012
Job Manufacturing Quality Manager at Elanco
Industry Pharmaceuticals
Experience
Elanco 2012 - Present
ProPharma Group March 2012 - August 2012
United States Steel Company 2008 - 2012
MonoSol Rx LLC 2006 - 2007
Takeda Abbott Pharmaceuticals 2002 - 2006
Takeda Abbott Pharmaceuticals 1999 - 2002
Abbott Healthcare 1995 - 1999
Abbott Health Products 1993 - 1995
Pfizer Pharmaceuticals Inc. 1990 - 1993
Pfizer Pharmaceuticals 1988 - 1990
Skills
FDA GMP, DEA, Pharmaceutical Industry, Pharmaceutics, Steel Plant, Change Control, CAPA, Quality Assurance, Quality Management, Quality System, Quality Control, Supplier Quality, Product Transfer, Technology Transfer, Controlled Substances, Validation, Computer System..., Cleaning Validation, HPLC, Gas Chromatography, TrackWise, PVWorks, Manufacturing, Lean Manufacturing, Contract Manufacturing, Contract Research..., ex-US Inspections, GxP, Supply Chain Management, FT-IR, Mass Spectrometry, SEM, Wet Chemistry, USP, Polymorph Screening, API manufacturing
Education
University of Puerto Rico-Rio Piedras 1982 — 1987
Bachelor's Degree, Chemistry, Cum Laude
Elanco 2012 - Present
ProPharma Group March 2012 - August 2012
United States Steel Company 2008 - 2012
MonoSol Rx LLC 2006 - 2007
Takeda Abbott Pharmaceuticals 2002 - 2006
Takeda Abbott Pharmaceuticals 1999 - 2002
Abbott Healthcare 1995 - 1999
Abbott Health Products 1993 - 1995
Pfizer Pharmaceuticals Inc. 1990 - 1993
Pfizer Pharmaceuticals 1988 - 1990
Skills
FDA GMP, DEA, Pharmaceutical Industry, Pharmaceutics, Steel Plant, Change Control, CAPA, Quality Assurance, Quality Management, Quality System, Quality Control, Supplier Quality, Product Transfer, Technology Transfer, Controlled Substances, Validation, Computer System..., Cleaning Validation, HPLC, Gas Chromatography, TrackWise, PVWorks, Manufacturing, Lean Manufacturing, Contract Manufacturing, Contract Research..., ex-US Inspections, GxP, Supply Chain Management, FT-IR, Mass Spectrometry, SEM, Wet Chemistry, USP, Polymorph Screening, API manufacturing
Education
University of Puerto Rico-Rio Piedras 1982 — 1987
Bachelor's Degree, Chemistry, Cum Laude
John Palka, PMP John Palka, PMP's ProPharma Group Experience October 2011 - March 2014
Job Quality, Risk and Compliance Consultant
Industry Pharmaceuticals
Experience
Cary, North Carolina ConsultantAzzur ConsultingMay 2014 - Present
ProPharma Group October 2011 - March 2014
United Therapeutics Corporation August 2010 - September 2011
Siemens IT Solutions and Services August 2008 - April 2010
Siemens Medical Solutions USA Inc. October 2006 - August 2008
Teleflex Medical May 2005 - October 2006
Bayer Healthcare April 1995 - April 2005
Skills
Quality Assurance, FDA, Change Control, 21 CFR Part 11, Pharmaceutical Industry, Regulatory Requirements, Computer System..., CAPA, Validation, GMP, Quality System, Sop, Quality Auditing, GxP, GAMP, Root Cause Analysis, Aseptic Processing, ISO 13485, GLP, V&V, Software Documentation, 21 CFR, Testing, Production Planning, Quality Control, 21 CFR Part 820, 21 CFR Part 210, 211, Business Analysis, Warehouse Operations, Quality Testing, Maintenance Management, Risk Assessment, User Requirements..., Functional Requirements..., Traceability Matrix, Configuration Testing..., Functional Testing (OQ), Requirements Testing..., Project Management
Education
University of Miami
Cary, North Carolina ConsultantAzzur ConsultingMay 2014 - Present
ProPharma Group October 2011 - March 2014
United Therapeutics Corporation August 2010 - September 2011
Siemens IT Solutions and Services August 2008 - April 2010
Siemens Medical Solutions USA Inc. October 2006 - August 2008
Teleflex Medical May 2005 - October 2006
Bayer Healthcare April 1995 - April 2005
Skills
Quality Assurance, FDA, Change Control, 21 CFR Part 11, Pharmaceutical Industry, Regulatory Requirements, Computer System..., CAPA, Validation, GMP, Quality System, Sop, Quality Auditing, GxP, GAMP, Root Cause Analysis, Aseptic Processing, ISO 13485, GLP, V&V, Software Documentation, 21 CFR, Testing, Production Planning, Quality Control, 21 CFR Part 820, 21 CFR Part 210, 211, Business Analysis, Warehouse Operations, Quality Testing, Maintenance Management, Risk Assessment, User Requirements..., Functional Requirements..., Traceability Matrix, Configuration Testing..., Functional Testing (OQ), Requirements Testing..., Project Management
Education
University of Miami
Jeff Green Jeff Green's ProPharma Group Experience September 2014 - January 2015
Job President/Owner and Principal Consultant; (Medical Device and Pharma Industries)
Industry Medical Devices
Experience
Dohmen Life Science Services April 2015 - Present
DePuy/Synthes January 2013 - Present
DayBreak Solutions. LLC (Medical Device Consulting) January 2005 - Present
ProPharma Group September 2014 - January 2015
Quality Hub Limited May 2014 - August 2014
Ellissen Consulting GmbH April 2014 - May 2014
Quantic Group June 2009 - February 2013
Validant March 2008 - December 2009
RCA 2008 - 2009
Quintiles 2007 - 2008
Skills
FDA, CAPA, Medical Devices, Process Validation, ISO 13485, Consent Decree, QSR, ISO, GMP, Regulatory Affairs, Training, Diagnostic, Pharmaceutical Industry, Biopharmaceuticals, Quality System, Quality Assurance, 21 CFR Part 11, Start-ups, Design Control, Change Control, Quality Control, Quality Auditing, Biotechnology, GLP, V, Validation, Computer System..., Cross-functional Team..., Document Management, V&V
Education
University of South Carolina-Columbia 1962 — 1966
BS, Biology, Pre Med.
Dohmen Life Science Services April 2015 - Present
DePuy/Synthes January 2013 - Present
DayBreak Solutions. LLC (Medical Device Consulting) January 2005 - Present
ProPharma Group September 2014 - January 2015
Quality Hub Limited May 2014 - August 2014
Ellissen Consulting GmbH April 2014 - May 2014
Quantic Group June 2009 - February 2013
Validant March 2008 - December 2009
RCA 2008 - 2009
Quintiles 2007 - 2008
Skills
FDA, CAPA, Medical Devices, Process Validation, ISO 13485, Consent Decree, QSR, ISO, GMP, Regulatory Affairs, Training, Diagnostic, Pharmaceutical Industry, Biopharmaceuticals, Quality System, Quality Assurance, 21 CFR Part 11, Start-ups, Design Control, Change Control, Quality Control, Quality Auditing, Biotechnology, GLP, V, Validation, Computer System..., Cross-functional Team..., Document Management, V&V
Education
University of South Carolina-Columbia 1962 — 1966
BS, Biology, Pre Med.
Dustin Kunce Dustin Kunce's ProPharma Group Experience June 2012 - Present
Job Validation Engineer II at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group June 2012 - Present
Education
University of Missouri-Columbia 2007 — 2011
Bachelor of Science (B.S.), Biology/Biological Sciences, General
ProPharma Group June 2012 - Present
Education
University of Missouri-Columbia 2007 — 2011
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Lucy Hodge's ProPharma Group Experience August 2013 - Present
Job Global Project Lead, Medical Information at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group August 2013 - Present
Freelance September 2011 - January 2015
Mayo Clinic, Rochester, MN August 2010 - August 2013
Lunds and Byerly's April 2007 - August 2013
University of Minnesota September 2006 - August 2010
Boehringer Ingelheim June 2008 - August 2008
Skills
Chemistry, Cell, PK/PD, Pharmacokinetics, Drug Delivery, Drug Metabolism, Pharmacodynamics, Pharmacology, LC-MS, In Vitro, HPLC, Cell Culture, Biochemistry, Pharmaceutical Research, Molecular Biology, ADME, Editing, Technical Writing, Mass Spectrometry, Clinical Research, Oncology, Toxicology, Science, Genetics, Pharmaceutical Industry
Education
University of Minnesota-Twin Cities 2006 — 2010
Doctor of Philosophy, Experimental and Clinical Pharmacology
University of Minnesota-Twin Cities 2002 — 2006
Doctor of Pharmacy
College of Saint Catherine 1998 — 2002
Bachelor of Arts, Chemistry
ProPharma Group August 2013 - Present
Freelance September 2011 - January 2015
Mayo Clinic, Rochester, MN August 2010 - August 2013
Lunds and Byerly's April 2007 - August 2013
University of Minnesota September 2006 - August 2010
Boehringer Ingelheim June 2008 - August 2008
Skills
Chemistry, Cell, PK/PD, Pharmacokinetics, Drug Delivery, Drug Metabolism, Pharmacodynamics, Pharmacology, LC-MS, In Vitro, HPLC, Cell Culture, Biochemistry, Pharmaceutical Research, Molecular Biology, ADME, Editing, Technical Writing, Mass Spectrometry, Clinical Research, Oncology, Toxicology, Science, Genetics, Pharmaceutical Industry
Education
University of Minnesota-Twin Cities 2006 — 2010
Doctor of Philosophy, Experimental and Clinical Pharmacology
University of Minnesota-Twin Cities 2002 — 2006
Doctor of Pharmacy
College of Saint Catherine 1998 — 2002
Bachelor of Arts, Chemistry
Dennis Hendrickson's ProPharma Group Experience April 2012 - August 2012
Job Pharmaceutical Consultant
Industry Pharmaceuticals
Experience
Consultant April 2007 - Present
Vanda Pharmaceuticals February 2012 - March 2015
ProPharma Group April 2012 - August 2012
Shire US Manufacturing Inc. 2004 - February 2007
sanofi-aventis January 1973 - February 2007
sanofi-aventis January 1973 - February 2007
Aventis Pharmaceuticals (and predecessor companies) 1973 - 2007
Aventis Pharmaceuticals 2000 - 2006
Skills
Regulatory Affairs, FDA, GMP, Pharmaceutical Industry, Sop, Validation, CAPA, Drug Development, Change Control, Regulatory Submissions, GCP, 21 CFR Part 11, Computer System..., Clinical Trials, Biopharmaceuticals, Clinical Development, Technology Transfer, CRO, GxP, LIMS, Regulatory Requirements, V&V, GLP, Biotechnology, Pharmaceutics, HPLC
Education
University of Missouri-Kansas City 1965 — 1970
Bachelor of Science (B.S.), Pharmacy
Park College 1966 — 1966
Chemistry
University of Missouri-Columbia
Arts and science
Consultant April 2007 - Present
Vanda Pharmaceuticals February 2012 - March 2015
ProPharma Group April 2012 - August 2012
Shire US Manufacturing Inc. 2004 - February 2007
sanofi-aventis January 1973 - February 2007
sanofi-aventis January 1973 - February 2007
Aventis Pharmaceuticals (and predecessor companies) 1973 - 2007
Aventis Pharmaceuticals 2000 - 2006
Skills
Regulatory Affairs, FDA, GMP, Pharmaceutical Industry, Sop, Validation, CAPA, Drug Development, Change Control, Regulatory Submissions, GCP, 21 CFR Part 11, Computer System..., Clinical Trials, Biopharmaceuticals, Clinical Development, Technology Transfer, CRO, GxP, LIMS, Regulatory Requirements, V&V, GLP, Biotechnology, Pharmaceutics, HPLC
Education
University of Missouri-Kansas City 1965 — 1970
Bachelor of Science (B.S.), Pharmacy
Park College 1966 — 1966
Chemistry
University of Missouri-Columbia
Arts and science
Jeff Cornish's ProPharma Group Experience October 2011 - April 2012
Job Validation Engineer at ProPharma Group
Industry Biotechnology
Experience
The DiLisi Group July 2014 - Present
JC Validation Services, LLC December 2008 - Present
The Dilisi Group August 2013 - October 2013
ProPharma Group October 2011 - April 2012
ProPharma Group July 2010 - February 2011
Agilent Technologies December 2008 - March 2010
Amgen, Inc. September 1999 - October 2007
Education
University of Colorado Boulder 1989 — 1995
The DiLisi Group July 2014 - Present
JC Validation Services, LLC December 2008 - Present
The Dilisi Group August 2013 - October 2013
ProPharma Group October 2011 - April 2012
ProPharma Group July 2010 - February 2011
Agilent Technologies December 2008 - March 2010
Amgen, Inc. September 1999 - October 2007
Education
University of Colorado Boulder 1989 — 1995
Shelley Allegretto's ProPharma Group Experience April 2012 - August 2012
Job Quality Compliance Nurse at Health Net Access
Industry Pharmaceuticals
Experience
Health Net Access October 2014 - Present
Health Choice Arizona August 2012 - October 2014
ProPharma Group April 2012 - August 2012
Carrington College April 2010 - April 2012
Octapharma December 2008 - December 2009
Talecris Plasma Resources December 2006 - December 2008
Bayada Nurses November 2005 - November 2006
MDS Pharma Services February 2005 - November 2005
International BioResources, LLC August 2003 - February 2005
Aventis Bio-Services February 2000 - July 2003
Skills
FDA, CAPA, Quality Assurance, Sop, Validation, Healthcare, Quality Auditing, Biotechnology, Pharmaceutical Industry, Quality System, Process Improvement, GMP, Medical Devices, Software Documentation, Hospitals, Quality Management, Clinical Research, Team Building, Change Control, Management, Training, Auditing, Quality Control, Cross-functional Team..., ISO 13485, Clinical Trials, Recruiting, SOP
Education
Carrington College 2010 — 2012
Associate degree, nursing
University of Phoenix
Associate of Arts, Business Administration and Management, General
Health Net Access October 2014 - Present
Health Choice Arizona August 2012 - October 2014
ProPharma Group April 2012 - August 2012
Carrington College April 2010 - April 2012
Octapharma December 2008 - December 2009
Talecris Plasma Resources December 2006 - December 2008
Bayada Nurses November 2005 - November 2006
MDS Pharma Services February 2005 - November 2005
International BioResources, LLC August 2003 - February 2005
Aventis Bio-Services February 2000 - July 2003
Skills
FDA, CAPA, Quality Assurance, Sop, Validation, Healthcare, Quality Auditing, Biotechnology, Pharmaceutical Industry, Quality System, Process Improvement, GMP, Medical Devices, Software Documentation, Hospitals, Quality Management, Clinical Research, Team Building, Change Control, Management, Training, Auditing, Quality Control, Cross-functional Team..., ISO 13485, Clinical Trials, Recruiting, SOP
Education
Carrington College 2010 — 2012
Associate degree, nursing
University of Phoenix
Associate of Arts, Business Administration and Management, General
Jenny Osberg, MBA's ProPharma Group Experience June 2004 - January 2007
Job Quality Engineer Pharma/Med Device
Industry Medical Devices
Experience
Osberg Residence November 2011 - Present
Boston Scientific January 2007 - November 2011
ProPharma Group June 2004 - January 2007
Tanis Technical December 2002 - May 2004
Skills
CAPA, V&V, ISO 13485, FDA, Validation, Quality System, 21 CFR, Medical Devices, 21 CFR Part 11, ISO 14971, Design Control, GMP, Computer System..., Root Cause Analysis, Change Control, Design of Experiments, Cleaning Validation, GAMP, Supplier Quality, Minitab, DMAIC, Quality Auditing, FMEA, CQE, Quality Control, SPC
Education
University of St. Thomas 2009 — 2013
Master of Business Administration (M.B.A.), Business
University of Oklahoma 1998 — 2003
Bachelor of Science, Chemical Engineering
Osberg Residence November 2011 - Present
Boston Scientific January 2007 - November 2011
ProPharma Group June 2004 - January 2007
Tanis Technical December 2002 - May 2004
Skills
CAPA, V&V, ISO 13485, FDA, Validation, Quality System, 21 CFR, Medical Devices, 21 CFR Part 11, ISO 14971, Design Control, GMP, Computer System..., Root Cause Analysis, Change Control, Design of Experiments, Cleaning Validation, GAMP, Supplier Quality, Minitab, DMAIC, Quality Auditing, FMEA, CQE, Quality Control, SPC
Education
University of St. Thomas 2009 — 2013
Master of Business Administration (M.B.A.), Business
University of Oklahoma 1998 — 2003
Bachelor of Science, Chemical Engineering
Paula Knabb's ProPharma Group Experience July 2013 - Present
Job Quality Assurance Engineer at ProPharma Group
Industry Biotechnology
Experience
ProPharma Group July 2013 - Present
Quintiles February 2012 - October 2012
ProPharma Group August 2011 - February 2012
Diosynth 2009 - March 2011
Diosynth April 2004 - March 2009
Diosynth January 2003 - April 2004
Diosynth July 2001 - January 2003
Education
University of Florida 1990 — 1994
Bachelor of Science, Microbiology and Cell Science
NC State University
ProPharma Group July 2013 - Present
Quintiles February 2012 - October 2012
ProPharma Group August 2011 - February 2012
Diosynth 2009 - March 2011
Diosynth April 2004 - March 2009
Diosynth January 2003 - April 2004
Diosynth July 2001 - January 2003
Education
University of Florida 1990 — 1994
Bachelor of Science, Microbiology and Cell Science
NC State University
Cheryl Fletcher's ProPharma Group Experience June 2012 - Present
Job Quality Assurance Manager at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group June 2012 - Present
Sandoz 2011 - Present
ProPharma Group February 2011 - June 2012
ProPharma Group August 2007 - February 2011
Pfizer 1983 - 2007
Skills
Validation, GMP, FDA, Sop, CAPA, Change Control, Quality System, Pharmaceutical Industry, GxP, Aseptic Processing, Quality Assurance, Quality Auditing, Quality Management, Auditing, Risk Assessment, Technical Writing, Deviations, Complaint Investigations, Biopharmaceuticals, SOP, 21 CFR Part 11
Education
University of Missouri-Columbia 1978 — 1982
BA, Microbiology
Raytown High School 1975 — 1978
ProPharma Group June 2012 - Present
Sandoz 2011 - Present
ProPharma Group February 2011 - June 2012
ProPharma Group August 2007 - February 2011
Pfizer 1983 - 2007
Skills
Validation, GMP, FDA, Sop, CAPA, Change Control, Quality System, Pharmaceutical Industry, GxP, Aseptic Processing, Quality Assurance, Quality Auditing, Quality Management, Auditing, Risk Assessment, Technical Writing, Deviations, Complaint Investigations, Biopharmaceuticals, SOP, 21 CFR Part 11
Education
University of Missouri-Columbia 1978 — 1982
BA, Microbiology
Raytown High School 1975 — 1978
Kris Williams's ProPharma Group Experience April 2012 - September 2013
Job Manager, Product Supply Integration Operations at Bayer HealthCare
Industry Pharmaceuticals
Experience
Bayer HealthCare September 2013 - Present
ProPharma Group April 2012 - September 2013
Aptuit August 2009 - April 2012
Aptuit January 2001 - August 2009
Quintiles 2001 - 2005
Bayer CropScience June 1992 - January 2001
Skills
GMP, GLP, Sop, Analytical Chemistry, HPLC, Pharmaceutics, Pharmaceutical Industry, CRO, Chromatography, LIMS, Chemistry, 21 CFR Part 11, Change Control, Clinical Trials, GCP, GxP, Quality Assurance, Quality Control, Validation, Drug Development, Technology Transfer, Clinical Development, IND, Contract Manufacturing, UV/Vis, Gas Chromatography, CMC, Trackwise, CAPA, Biopharmaceuticals, Quality System, Lifesciences, Regulatory Requirements, Regulatory Affairs, Regulatory Submissions, FDA, V&V, Laboratory, GAMP, Biotechnology, Computer System..., Drug Discovery, SOP
Education
University of Missouri-Kansas City
BS, Chemistry
Bayer HealthCare September 2013 - Present
ProPharma Group April 2012 - September 2013
Aptuit August 2009 - April 2012
Aptuit January 2001 - August 2009
Quintiles 2001 - 2005
Bayer CropScience June 1992 - January 2001
Skills
GMP, GLP, Sop, Analytical Chemistry, HPLC, Pharmaceutics, Pharmaceutical Industry, CRO, Chromatography, LIMS, Chemistry, 21 CFR Part 11, Change Control, Clinical Trials, GCP, GxP, Quality Assurance, Quality Control, Validation, Drug Development, Technology Transfer, Clinical Development, IND, Contract Manufacturing, UV/Vis, Gas Chromatography, CMC, Trackwise, CAPA, Biopharmaceuticals, Quality System, Lifesciences, Regulatory Requirements, Regulatory Affairs, Regulatory Submissions, FDA, V&V, Laboratory, GAMP, Biotechnology, Computer System..., Drug Discovery, SOP
Education
University of Missouri-Kansas City
BS, Chemistry
Rich Horowitz's ProPharma Group Experience 2013 - 2013
Job QA compliance consultant at RLH Consulting
Industry Pharmaceuticals
Experience
KKAI 2010 - Present
RLH Consulting 2001 - Present
ProPharma Group 2013 - 2013
QSC 2012 - 2012
NutraMax 1998 - 2000
Astra 1997 - 1998
Copley Pharamceutical 1990 - 1998
Copley Pharma 1990 - 1996
Lederle 1978 - 1984
Skills
Change Control, Validation, CAPA, Process Validation, GMP, cGMP, SOP, Pharmaceuticals, Quality Systems, Quality Assurance, Quality Auditing, Packaging, R&D, Quality System, Sop, GLP, ISO 13485, Pharmaceutical Industry, FDA, Regulatory Affairs, Quality Control, Medical Devices, V&V, HPLC, 21 CFR Part 11, Pharmaceutics, GxP, Computer System...
Education
University of Maryland College Park 1970 — 1973
Bachelor of Science (BS), Biochemistry
KKAI 2010 - Present
RLH Consulting 2001 - Present
ProPharma Group 2013 - 2013
QSC 2012 - 2012
NutraMax 1998 - 2000
Astra 1997 - 1998
Copley Pharamceutical 1990 - 1998
Copley Pharma 1990 - 1996
Lederle 1978 - 1984
Skills
Change Control, Validation, CAPA, Process Validation, GMP, cGMP, SOP, Pharmaceuticals, Quality Systems, Quality Assurance, Quality Auditing, Packaging, R&D, Quality System, Sop, GLP, ISO 13485, Pharmaceutical Industry, FDA, Regulatory Affairs, Quality Control, Medical Devices, V&V, HPLC, 21 CFR Part 11, Pharmaceutics, GxP, Computer System...
Education
University of Maryland College Park 1970 — 1973
Bachelor of Science (BS), Biochemistry
Larry Chan's ProPharma Group Experience 2010 - 2013
Job Senior LeaderQuality, Compliance, & Computer Systems
Industry Biotechnology
Experience
Onyx Pharmaceuticals (Amgen) 2013 - Present
Q Innovative Strategies 2013 - 2013
ProPharma Group 2010 - 2013
Agensys 2012 - 2012
Noven Pharmaceuticals 2011 - 2012
BioMarin 2010 - 2011
Baxter BioScience 2009 - 2010
The Validation Company 1997 - 2009
MedImmune Vaccines 2008 - 2008
Baxter BioScience 1998 - 2008
Skills
Validation, Quality System, Computer System..., CAPA, Compliance, GMP, FDA GMP, Change Management, Validation Master Plans, Quality Assurance, Quality Management, Water Quality, Commissioning Management, Project Management, Biotechnology, Change Control, Lean Thinking, Regulatory Requirements, Sop, V&V, FDA, Regulatory Affairs, Quality Auditing, 21 CFR Part 11, GAMP, Medical Devices, GxP, Aseptic Processing, Pharmaceutical Industry, ISO 13485, Technology Transfer, Quality Control
Education
University of California, Los Angeles
BS, Electrical Engineering
Onyx Pharmaceuticals (Amgen) 2013 - Present
Q Innovative Strategies 2013 - 2013
ProPharma Group 2010 - 2013
Agensys 2012 - 2012
Noven Pharmaceuticals 2011 - 2012
BioMarin 2010 - 2011
Baxter BioScience 2009 - 2010
The Validation Company 1997 - 2009
MedImmune Vaccines 2008 - 2008
Baxter BioScience 1998 - 2008
Skills
Validation, Quality System, Computer System..., CAPA, Compliance, GMP, FDA GMP, Change Management, Validation Master Plans, Quality Assurance, Quality Management, Water Quality, Commissioning Management, Project Management, Biotechnology, Change Control, Lean Thinking, Regulatory Requirements, Sop, V&V, FDA, Regulatory Affairs, Quality Auditing, 21 CFR Part 11, GAMP, Medical Devices, GxP, Aseptic Processing, Pharmaceutical Industry, ISO 13485, Technology Transfer, Quality Control
Education
University of California, Los Angeles
BS, Electrical Engineering
Michael Vardon's ProPharma Group Experience May 2012 - July 2012
Job Consumer Safety Officer at FDA
Industry Biotechnology
Experience
FDA July 2012 - Present
ProPharma Group May 2012 - July 2012
Human Genome Sciences January 2006 - January 2012
Human Genome Sciences January 2005 - January 2006
Human Genome Sciences January 2004 - January 2005
Human Genome Sciences January 2003 - January 2004
Human Genome Sciences March 2002 - January 2003
MedImmune January 2000 - March 2002
MedImmune September 1998 - January 2000
Skills
Biotechnology, Biopharmaceuticals, cGMP, Cell Culture, Protein Purification, Purification, Chromatography, GLP, Technology Transfer, Regulatory Affairs, FDA, GMP, Quality Assurance, Sop, SOP, Protein Chemistry, CAPA, Life Sciences
Education
University of Maryland College Park
BS, Chemistry
University of Maryland University College
Graduate Certificate, Software Engineering
FDA July 2012 - Present
ProPharma Group May 2012 - July 2012
Human Genome Sciences January 2006 - January 2012
Human Genome Sciences January 2005 - January 2006
Human Genome Sciences January 2004 - January 2005
Human Genome Sciences January 2003 - January 2004
Human Genome Sciences March 2002 - January 2003
MedImmune January 2000 - March 2002
MedImmune September 1998 - January 2000
Skills
Biotechnology, Biopharmaceuticals, cGMP, Cell Culture, Protein Purification, Purification, Chromatography, GLP, Technology Transfer, Regulatory Affairs, FDA, GMP, Quality Assurance, Sop, SOP, Protein Chemistry, CAPA, Life Sciences
Education
University of Maryland College Park
BS, Chemistry
University of Maryland University College
Graduate Certificate, Software Engineering
Kay Voorhes, MBA, CQA's ProPharma Group Experience April 2012 - Present
Job Consultant at ProPharma Group
Industry Biotechnology
Experience
ProPharma Group April 2012 - Present
Talecris Plasma Resources January 2008 - April 2012
BioLife July 2000 - January 2008
Skills
Certified Quality..., Internal Audit, Compliance Audits, Quality Assurance, Quality Management, Training & Development, Supervisory Skills, Supervisory Experience, Team Leadership, SOP, CLIA, FDA, Critical Thinking, Analytical Abilities, Organizational..., Team Building, Code of Federal..., cGMP, Eye For Detail, Attention To Detail, V&V, Sop, Change Control, Quality Auditing, CQA, GMP, Analytical Skills, Process Improvement, Validation, Root Cause Analysis, Troubleshooting, CAPA, Training, ISO 13485, Quality System, GLP, Quality Control, Regulatory Requirements, LIMS, GAMP, Regulatory Affairs, Computer System..., Biopharmaceuticals, Aseptic Processing
Education
University of Phoenix 2006 — 2007
Master of Business Administration (MBA)
University of Phoenix 2002 — 2006
Bachelor of Science (BS), Business Management
ProPharma Group April 2012 - Present
Talecris Plasma Resources January 2008 - April 2012
BioLife July 2000 - January 2008
Skills
Certified Quality..., Internal Audit, Compliance Audits, Quality Assurance, Quality Management, Training & Development, Supervisory Skills, Supervisory Experience, Team Leadership, SOP, CLIA, FDA, Critical Thinking, Analytical Abilities, Organizational..., Team Building, Code of Federal..., cGMP, Eye For Detail, Attention To Detail, V&V, Sop, Change Control, Quality Auditing, CQA, GMP, Analytical Skills, Process Improvement, Validation, Root Cause Analysis, Troubleshooting, CAPA, Training, ISO 13485, Quality System, GLP, Quality Control, Regulatory Requirements, LIMS, GAMP, Regulatory Affairs, Computer System..., Biopharmaceuticals, Aseptic Processing
Education
University of Phoenix 2006 — 2007
Master of Business Administration (MBA)
University of Phoenix 2002 — 2006
Bachelor of Science (BS), Business Management
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY