Polaris Compliance Consultants, Inc.
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Polaris Compliance Consultants, Inc. Employees
Triangle Clinical Research, LLC July 2012 - Present
Piedmont Medical Writers LLC January 2012 - January 2012
Polaris Compliance Consultants, Inc. February 2011 - February 2011
Piedmont Medical Writers LLC June 2010 - December 2010
Lineberry Research Associates/Constella Group August 2004 - March 2007
Lineberry Research Associates October 2001 - April 2004
Lineberry Research Associates January 1999 - September 2001
Skills
Microsoft Office, Clinical Research, Clinical Trials, Clinical Monitoring, Document Quality Control, Pharmaceutical Industry, Regulatory Submissions, Sop, ICH-GCP
Education
North Carolina State University 1994 — 1998
Bachelor of Science (BS), Biology/Biological Sciences, General
Tunnell Consulting March 2010 - Present
Polaris Compliance Consultants, Inc. August 2008 - Present
Omega Consulting, LLC July 2008 - Present
Enzon Pharmaceuticals 2005 - 2008
Alpharma 2002 - 2005
Alpharma 2001 - 2002
Alpharma 2001 - 2001
CasChem 1992 - 2001
Skills
Auditing, Investigations, Organizational..., GMP, Quality Systems, Quality Assurance, Biotechnology, Compliance, Manufacturing, cGMP, Technology Transfer, Validation, Pharmaceuticals, SOP, Process Validation, FDA, CAPA, Life Sciences, Change Control, Process Improvement, Continuous Improvement, Change Management, Quality Management, Quality Auditing, Documentation, ISO, Coaching, Operational Excellence, Problem Solving, Mentoring, Team Building, Budgeting, Management Consulting, Root Cause Analysis, QC, Aseptic Processing, Kaizen, Document Management, Cost Reduction, Process Optimization, TQM, Sop, Quality System, Pharmaceutical Industry, Lifesciences, Quality Control, Regulatory Requirements, Software Documentation, V&V, Chemistry
Education
Penn State University 1972 — 1975
Ph.D., Chemistry
State University of New York College at Cortland 1967 — 1972
B.S., Chemistry
Polaris Compliance Consultants, Inc. August 1997 - Present
NCCSQA 2003 - 2011
Copernicus Group IRB 1999 - 2004
Cato Research 1989 - 1993
Burroughs Wellcome Co 1977 - 1989
Skills
GMP, Medical Devices, GCP, GLP, Biotechnology, Clinical Trials, Sop, Clinical Research, Pharmaceutics, Pharmaceutical Industry, 21 CFR Part 11, Clinical Development, CRO, FDA, Regulatory Affairs, Regulatory Submissions, Drug Development, Validation, Lifesciences, Change Control
Education
Wilson College 1973 — 1977
BS, Biology
Meredith College
MBA, Business Administration
KKW Consulting, Inc January 1999 - Present
Polaris Compliance Consultants, Inc. 2005 - 2012
Triangle Pharmaceuticals (aka Gilead Sciences) 1999 - 2001
PPD Pharmaco 1998 - 1999
PPD Pharmaco 1996 - 1998
PPD Pharmaco 1995 - 1996
Clin Trials Research 1991 - 1995
Clinical Research International 1988 - 1991
Skills
GCP, Clinical Research, CRO, Phase I, SOP, Auditing, Protocol Development, Contract Management, Clinical Monitoring, Clinical Trial..., Clinical Trials, EDC, Oncology, Endocrinology, Medical Writing, Infectious Diseases, Gastroenterology, Cardiology, Neurology, Research, Cancer, Clinical, Pharmaceuticals, Pharmacovigilance, Sop, Pharmaceutical Industry, Respiratory Disease, Allergy, Clinical Operations, Protocol, CAPA, CTMS, Clinical Development, Clinical Study Design, 21 CFR Part 11, Drug Safety, Regulatory Affairs
Education
University of North Carolina at Chapel Hill 1984 — 1986
MPH, Health Education/Health Behavior
Guilford College 1976 — 1980
BS, Biology/pre-med
Polaris Compliance Consultants, Inc. February 2006 - Present
Polaris Compliance Consultants, Inc. January 2009 - January 2011
Research Dynamics Consulting Group. Ltd. February 2000 - February 2006
Hill Top Research, Inc. January 1999 - February 2000
Affilitated Research Centers, Inc. 1994 - 1999
PAREXEL 1993 - 1994
General Electric Medical Systems 1990 - 1993
Bristol Myers Squibb, Inc. 1984 - 1990
Skills
Quality Auditing, Clinical Trials, Clinical Research, GCP, Clinical Development, Medical Devices, Regulatory Affairs, CRO, Quality Assurance, Training, Auditing, CAPA, Pharmaceutical Industry, FDA, Clinical site management, Global Regulatory..., 21 CFR Part 11, ICH-GCP, Oncology, Sop, Clinical Site Management, CTMS
Education
Rutgers University-New Brunswick 1985 — 1987
BS, POE-Healthcare Managment
Duke University 1977 — 1978
Nuclear Medicine Technology
Morehead State University
AAS, Radiologic Technology
Polaris Compliance Consultants, Inc. July 2007 - Present
AMS Creative Value Solutions,LLC 2014 - 2015
Banner Pharmacaps 2004 - 2007
Banner Pharmacaps June 1998 - June 2004
Ranbaxy 1996 - 1998
Medco Research 1994 - 1996
Cato Research 1992 - 1994
Boots Pharmaceutical 1988 - 1992
Baxter Healthcare 1983 - 1988
GD Searle 1980 - 1983
Skills
FDA, CAPA, GMP, GLP, Sop, Compliance, Change Control, Medical Compliance, Cleaning Validation, Regulatory Affairs, Clinical Development, 21 CFR Part 11, Pharmaceutical Industry, GxP, GCP, Validation, V&V, Quality Assurance, Pharmaceutics, ICH guidelines, Trackwise, CRO, Regulatory Requirements, ISO 13485, Design Control, Computer System..., CTMS, GAMP, Clinical Trials, Quality System, Biopharmaceuticals, Drug Delivery, FDA GMP, Aseptic Processing, Biotechnology, Quality Auditing, ICH-GCP, Vaccines, LIMS, Dissolution, NDA, Clinical Research, Formulation, Lifesciences, Drug Development, Regulatory Submissions, IND, ANDA, CMC, Chromatography
Education
Loyola University of Chicago 1973 — 1975
Biology, General
ImClone Systems May 2009 - Present
Polaris Compliance Consultants, Inc. September 2008 - May 2009
PTC 2009 - 2009
Enzon Pharmaceutical Inc. June 1992 - June 2008
Beckman Instruments 1982 - 1992
Skills
CAPA, GMP, Sop, FDA, Validation, Change Control, 21 CFR Part 11, Quality Assurance, Software Documentation, GxP, Aseptic Processing, LIMS, Clinical Development
Education
Rider University 1964 — 1966
Nuchols Consulting March 2007 - Present
Polaris Compliance Consultants, Inc. 2007 - Present
University of Louisville 2010 - Present
Pluris, Inc January 2010 - Present
Kendle International, Inc January 2003 - May 2006
Oakwood Laboratories March 2001 - January 2003
Ricerca, L.L.C January 2000 - March 2001
BAS Analytics July 1995 - January 2000
International Research and Development Corporation January 1992 - January 1994
Stolle Research and Development Corporation January 1991 - January 1992
Skills
GLP, GCP, Clinical Trials, Clinical Research, CRO, Research, Toxicology, SOP, Quality Assurance, 21 CFR Part 11, Auditing, Pharmaceuticals, Analytical Chemistry, Microsoft Office, Clinical Development, Compliance, Regulatory Requirements, HPLC, Documentation, Quality Auditing, Excel, ICH-GCP, Sop, Lifesciences, Pharmaceutical Industry, Microsoft Excel
Education
University of Kentucky 1986 — 1989
Master of Science, Toxicology
Wright State University 1981 — 1986
Bachelor of Science, Biological Sciences
Columbia State Community College 1979 — 1981
Associate of Applied Science, Animal Hospital Technology
Polaris Compliance Consultants, Inc. October 2006 - Present
Starwalker Consulting Corporation June 1995 - May 2012
Massage Heights Franchise November 2007 - November 2010
Knowledge Systems Corporation 1998 - 2000
IBM May 1977 - May 1995
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 1990 — 1992
MBA
Bemidji State University 1973 — 1977
BS
inVentiv Health Clinical September 2013 - Present
Polaris Compliance Consultants, Inc. November 2011 - Present
ACRP 2010 - February 2014
Quintiles (contracted through Valesta) March 2013 - June 2013
Duke University Medical Center January 2010 - May 2010
Dr. Richard H. Weisler, M.D., P.A. & Associates August 2009 - December 2009
Renaissance May 1994 - September 1996
ROLM September 1985 - April 1994
Skills
Pharmaceutics, GLP, Training, GMP, Computer System...
Education
Durham Technical Community College 2005 — 2010
Assoc, Clinical Trials
Bowling Green State University 1978 — 1982
BS, Computer Science
Polaris Compliance Consultants, Inc. April 2012 - Present
Independent Quality Consultant January 2011 - Present
PharmaDirections February 2011 - Present
Whitsell Innovations, Inc. 2012 - 2013
Brooke Moody, L.L.C. 2011 - 2012
AlphaVax March 2009 - February 2010
Qualicaps June 2008 - March 2009
Amylin Pharmaceuticals September 2006 - February 2008
Althea Technologies February 2005 - September 2006
Isis Pharmaceuticals November 2003 - February 2005
Skills
cGMP, Quality Auditing, Quality Systems, SOP, FDA, CAPA, Quality Assurance, Pharmaceuticals, Clinical Trials, Pharmaceutical..., Quality System, GMP
Education
Florida Atlantic University 1995 — 1999
Bachelor of Science, Chemistry