The Quantic Group, Ltd
Industry: Company
DescriptionFounded: 1988 Subsidiary: Quantic Oil Ltd
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The Quantic Group, Ltd Employees
The Quantic Group, Ltd September 2010 - Present
Baxter International Inc. February 2014 - December 2014
Tunnell Consulting, Inc. 2012 - 2013
Lachman Consultant Services 2009 - 2010
Sanofi Aventis, Sanofi Pasteur May 2007 - July 2009
University of Phoenix 2002 - 2009
Merck Schering-Plough Pharmaceuticals 2002 - 2006
Schlumberger 1995 - 2001
Reckitt Benckiser January 1990 - 1993
Skills
Quality System, Medical Devices, ISO13485, Project Management, Program Management, Manufacturing, Validation, Post Market Surveillance, Management Consulting, Complaint Investigations, Deviation Management, Biotechnology, Stability Studies, Analytical Biochemistry, Lifesciences, Sterility Assurance, Management, Sop, Business Process, GMP, Quality Management, Leadership, FDA, CAPA, Quality Assurance, Change Control, Life Sciences, SOP
Education
University of Phoenix 2004 — 2009
Doctor of Management in Organizational Leadership, Leadership and Organizational Effectivess
Drexel University - College of Business and Administration 1993 — 1995
MBA, Marketing and International Business
Institute of Business Administration 1989 — 1991
Post Graduate Diploma, Business Administration, 3.65
NED University of Engineering and Technology 1981 — 1985
BSME, Mechanical & Process Engineering
ProPharma Group - Regeneron December 2014 - Present
Osani Quality Consulting, LLC. December 2011 - Present
Bestech GMP Contracting February 2014 - November 2014
Ranbaxy April 2013 - January 2014
The Quantic Group, Ltd August 2012 - February 2013
Aerotek July 2012 - August 2012
Quantic- Novartis project April 2012 - June 2012
Quintiles- Hospira project January 2012 - April 2012
Caraco Pharmaceutical Laboratories March 2011 - January 2012
IMPAX Labs January 2008 - March 2011
Skills
QA & Compliance, Pharmaceutical, Management, QA/Compliance Auditing, Training & Development, Quality Systems, CAPA, Quality Assurance, cGMP, CQA, SOP, Generics, Personnel, Supervisory Skills, Aseptic Technique, Process Validation, Cleaning Validation, Contamination Control, pH meter, MSDS, Clean Rooms, cGMP/QA/Pharma..., Complaint Management, Supplier Audits, Preventive Actions, Supplier Auditing, Quality System, Sop, Solid Oral Dosage Forms, Change Control, Pharmaceutical Industry, Creams, GxP, Quality Auditing, Regulatory Requirements, Aseptic Processing, Quality Management, Document Management, Root Cause Analysis, Protocol, Trackwise, Consent Decree, Deviation Management, PAI, Pharmaceutics, GMP, Regulations, USP, Contract Manufacturing, ANDA
Education
California State University-Dominguez Hills 2004 — 2010
M.S, Quality Assurance
State University of New York College at Brockport 1985 — 1987
B.S., Chemistry
MLP GxP Solutions, LLC, Inc. March 2012 - Present
Innovative Consultants GXP July 2011 - Present
Exemplar Compliance August 2014 - November 2014
The Quantic Group, Ltd March 2012 - July 2014
King Pharmaceuticals a wholly owned subsidiary of Pfizer August 2010 - July 2011
Apotex Inc. February 2010 - August 2010
Talecris Plasma Resources January 2008 - November 2009
Erimos Pharmaceuticals LLC, Raleigh, NC 2006 - 2008
DSM Pharmaceuticals 2002 - 2006
Alpharma USPD November 1999 - July 2002
Skills
Sop, GMP, Pharmaceutical Industry, CAPA, Root Cause Analysis, Quality Assurance, Quality System, Quality Management, Regulatory Requirements, Regulatory Affairs, 21 CFR, Pharmaceutical..., Pharmaceutical Sciences, FDA, Change Control, Document Management, Quality Control, Reviews, Troubleshooting, Specifications, Deviation Management, GxP, HPLC, Quality Auditing, Aseptic Processing, Pharmaceutics, Deviations, Validation, Drug Development, Biotechnology, 21 CFR Part 11, Analytical Chemistry, Biopharmaceuticals, CRO, Clinical Development, Clinical Trials, GAMP, IND, GLP, LIMS, Laboratory, Lifesciences, Protocol, Regulatory Submissions, Technology Transfer, Manufacturing, GCP, V, Cleaning Validation, SOP
Education
State University of New York College at Buffalo 1988 — 1991
BS
State University of New York at Buffalo 1988 — 1991
Bachelor of Science
QORM August 2013 - Present
The Quantic Group, Ltd. 2005 - Present
German Saturday School Boston 2011 - Present
Trinetra January 2004 - July 2013
Navigant Consulting May 2008 - April 2009
Defined Health 2005 - 2005
Accenture January 2001 - December 2003
Bayer Pharmaceuticals 1997 - 2000
Genome Therapeutics 1995 - 1996
Skills
Quality System, Strategy, Analysis, Biotechnology, Pharmaceutical Industry, R&D, Sop, Statistics, Large-scale Data..., Product Development, Management, Lifesciences, Technology Transfer, FDA, Validation, Change Control, GxP, CAPA, GMP, GLP, 21 CFR Part 11, Regulatory Affairs, Software Documentation, Quality Assurance, LIMS, Pharmaceutics, Clinical Trials, V&V, Commercialization, Medical Devices, Biopharmaceuticals
Education
Brandeis University 1993 — 1995
Postdoctoral Fellowship, Biophysics - Bioinformatics
Technical University Munich 1989 — 1993
Ph.D., Biophysics
Universität Hamburg 1983 — 1989
Ms. Sc. (Diplom-Physiker), Physics
Validant January 2015 - Present
Drug Development Resources September 2012 - Present
Compass Pharma Consulting, LLC September 2011 - Present
Anika Therapeutics July 2014 - January 2015
NextPharma July 2013 - April 2014
Complya Consulting Group January 2011 - April 2014
Ebewe Pharma December 2011 - December 2012
The Quantic Group, Ltd August 2011 - December 2012
AVEO Pharmaceuticals January 2011 - August 2011
Biogen Idec August 2007 - December 2010
Skills
Investigations, Compliance, Validation, Process Improvement, Process Optimization, Medical Devices, Regulatory Submissions, Continuous Improvement, Troubleshooting, Quality Assurance, Quality Management, Contract Manufacturing, GxP, Change Management, FDA, Quality Systems, Quality Auditing, Pharmaceuticals, Root Cause Analysis, Biotechnology, Operational Excellence, Problem Solving, Technology Transfer, Supplier Management, ISO 13485, GMP, Auditing, GCP, Clinical Trials, Regulatory Requirements, Quality System, Pharmaceutical Industry, 21 CFR Part 11, V&V, CAPA, Change Control, Biopharmaceuticals, Supply Management, Regulatory Affairs, Pharmaceutics, Computer System..., Sop, Clinical Development, GLP, Process Simulation, Manufacturing, LIMS, Aseptic Processing, Drug Development, R&D
Education
Northwestern University 2004 — 2006
Masters of Science, Product Development
University of Münster 1981 — 1990
Dr. rer. nat. (Ph.D.), Chemistry
Ostrove Associates,Inc. April 1999 - Present
CfPIE 2008 - Present
The Quantic Group, Ltd. 2000 - Present
NJIT 2002 - 2009
Fluor Daniel 1996 - 1999
Lockwood Greene 1993 - 1996
Davy McKee/John Brown 1988 - 1993
Amersham Pharmacia Biotech May 1984 - June 1988
Skills
GMP Training, Validation Management, Computer System..., Cleaning Validation, Process Validation, GMP Audits, GMP, Validation, FDA, cGMP, Auditing, Quality Systems, V&V, Quality System, Management, CAPA, 21 CFR Part 11, Pharmaceutical Industry, Biotechnology, Sop, Change Control, Biopharmaceuticals, Regulatory Affairs, Technology Transfer, Chromatography, Aseptic Processing, Quality Assurance, GLP, Process Improvement, Regulatory Requirements, Lifesciences, Quality Auditing, Regulatory Submissions, Pharmaceutics, Medical Devices, Vaccines, Cell Culture, GxP, ISO 13485, Microbiology, LIMS, HPLC, Drug Development, R&D, Chemistry, Sterilization, Drug Discovery, Analytical Chemistry, Commercialization, Laboratory
Education
Rutgers, The State University of New Jersey-Newark 1979 — 1981
Ph.D., Biochemistry
Adelphi University 1971 — 1975
MS, Biology
State University of New York at Albany 1964 — 1968
BS, Biology/Chemistry
The Quantic Group, Ltd October 2012 - Present
SAVECO, LLC January 2011 - Present
Global Automation Partners June 2004 - September 2011
SAVECO, LLC October 2001 - July 2004
VAI March 1998 - December 2001
Skills
DCS, MES, Automation, PLC, Control Systems Design, Validation, Process Control, SCADA, GAMP, Testing, Process Automation, WebDAV, Engineering, Wonderware, HMIs, Control Logic, Instrumentation, 21 CFR Part 11, Computer System..., Allen Bradley, Allen-Bradley
Education
University of Hartford 1975 — 1979
BS, Electronic Engineering
Hoinowski Consulting, LLC June 2009 - Present
The Quantic Group, Ltd. 1994 - June 2009
Skills
GMP, Change Control, 21 CFR Part 11, CAPA, Validation, Chemistry, Pharmaceutical Industry, Quality Management, Quality Control, FDA, Manufacturing, Pharmaceutics, Quality System, Sop, V&V, Technology Transfer, Aseptic Processing, Biopharmaceuticals, GxP, Computer System..., LIMS, Regulatory Requirements, Regulatory Affairs, GLP, Laboratory
Education
New York University - Polytechnic School of Engineering 1964 — 1970
MS +, Chemistry; Analytical and Organic
Powers Consulting April 1999 - Present
ISO/TC 212 1995 - Present
QSCS 2012 - 2014
QSCS 2012 - 2014
QualityHub 2005 - 2009
Quintiles January 2000 - January 2008
The Quantic Group, Ltd. September 2002 - June 2004
Ortho-Clinical Diagnostics/J&J November 1994 - June 1999
Eastman Kodak September 1976 - November 1994
Hahnemann University Hospital 1976 - 1978
Skills
Risk Management, ISO 14971, Quality System, Medical Devices, IVDs, Design Control, CAPA, MDRs, Health Hazard Evaluation, FDA, Regulatory Compliance, Complaint Handling, ISO 13485
Education
Cornell University 1964 — 1969
PhD
Wheeling Jesuit University 1959 — 1963
BS
CCHS 1955 — 1959
The Quantic Group, Ltd. October 2010 - Present
YourEncore January 2012 - June 2012
YourEncore March 2011 - May 2011
Eli Lilly and Company September 2004 - January 2008
Eli Lilly and Company January 2000 - August 2004
Eli Lilly and Company January 1998 - June 2000
Eli Lilly and Company December 1990 - December 1997
Eli Lilly and Company August 1989 - November 1990
Eli Lilly and Company January 1988 - August 1989
Eli Lilly and Company August 1987 - January 1988
Skills
Technical Transfers, Clinical Trial Materials, Product Development, GMP, Project Management, Pharmaceutical Industry, Drug Development, Leadership, Technology Transfer, Clinical Trials, Quality Assurance, Management, Clinical Development, Biotechnology, Analysis, Lifesciences, Validation, Quality System, Pharmaceutics, V&V
Education
Butler University 1973 — 1978
B.S., Pharmacy
The Janssen Pharmaceutical Companies of Johnson & Johnson July 2015 - Present
New York Medical College 1990 - Present
Celgene Cellular Therapeutics January 2013 - February 2015
The Quantic Group, Ltd January 2012 - December 2012
Merck January 2011 - December 2011
Johnson & Johnson 1997 - 2010
Ares Advanced Technology 1996 - 1997
Wyeth Research/Lederle Labs 1986 - 1996
Education
Rutgers University, Center for Management Development
Mini-MBA in Global BioPharma Entrepreneurship
Brandeis University
PhD, Biochemistry, Molecular Biology
Cornell University
BA, Biology, Biochemistry
Balm Chicky Balm Balm May 2009 - Present
Oregon Health Science University May 2010 - May 2015
The Bite of Oregon August 2008 - October 2008
University of Medicine and Dentistry July 2002 - August 2006
The Quantic Group, Ltd November 2000 - January 2001
Prevent Child Abuse - New Jersey April 1997 - June 1999
Skills
Grant Writing, Event Planning, Nonprofits, Healthcare, Non-profits, Marketing, Training, Team Building, Strategic Planning, Sales, Management, Public Speaking, Leadership
Education
West Chester University of Pennsylvania 1992 — 1996
West Chester University
B.A, Communicative Disorders
Seton Hall University
The Quantic Group Ltd March 2003 - Present
BlackLight Power, Inc. April 1999 - March 2003
NeoStrata Company March 1997 - April 1999
Skills
Auditing, Microsoft Excel, Microsoft Word, Microsoft Office, Training, Document Management, Management, Quicken, Invoicing, Expense Reports, QuickBooks, Accounts Receivable, Accounts Payable, Project Management, Spreadsheets, Human Resources, Process Improvement
Education
University of Phoenix 2006 — 2008
Master of Business Administration (MBA), Business Administration and Management, General
Centenary College 2003 — 2005
Bachelor of Science (B.S.), Business Administration and Management, General
The Quantic Group Ltd. 2010 - Present
Various February 2003 - March 2008
Warner Lambert Co./ Pfizer December 1997 - December 2000
Warner Lambert Co July 1996 - December 1997
Warner Lambert Co. November 1994 - July 1996
Warner Lambert Co. August 1993 - November 1994
Warner Lambert Co. November 1990 - August 1993
Warner Lambert Co. July 1987 - November 1990
Skills
Change Control, Project Management, Commercialization, Quality Assurance, FDA, Program Management, GxP, Technology Transfer, Pharmaceutics, Sourcing, Supply Chain, Regulatory Affairs, CAPA, Product Development, GMP, Negotiation, 21 CFR Part 11, Integration, Validation, Manufacturing, Management, Business Development, Pharmaceutical Industry, Outsourcing
Education
Fairleigh Dickinson University-Florham Campus
MBA, Management
St. Thomas Aquinas College
BS, Natural Science/ Medical Technology
The Quantic Group, Ltd August 2011 - October 2014
McKinsey & Company August 2006 - August 2010
Skills
Strategy, Change Management, Strategic Planning, Microsoft Word, Management Consulting, Analysis, Consulting, Microsoft Office, Risk Management
Education
Rutgers, The State University of New Jersey-New Brunswick 2003 — 2011
Psychology
Raritan Valley Community College 2001 — 2003
AA, Liberal Arts
Ridge
Pharmaceutical Technical Services December 1995 - Present
The Quantic Group, Ltd May 2012 - Present
Lachman Consultants March 2009 - May 2012
University of Wisconsin-Madison Engineering Continuing Professional Education 2009 - 2012
Center for Professional Advancement June 2002 - 2009
The Quantic Group, Ltd. September 1998 - July 2008
Bio and Pharmaceutical Consultants November 2004 - February 2005
Delaware Valley College February 1999 - May 2003
Chestnut Hill College April 1995 - July 1997
Quasar Engineering August 1992 - December 1995
Skills
Project Engineering, Equipment Qualification, Compliant Calibration..., Compliant Maintenance..., Compliant Pest Control..., CGMP Operations, Facilities and..., Compliant Facilities..., Utilities Validation, GMP, Validation, Facilities Management, Change Control, Calibration, Manufacturing, Quality Assurance, Quality System, Pharmaceutical Industry, Quality Control, CAPA, Quality Management, FDA GMP, Quality Auditing, Continuous Improvement, Technology Transfer, Sop, Pharmaceutics, 21 CFR Part 11, Laboratory, GLP, Regulatory Affairs, ISO 13485, Biotechnology, SOP
Education
Drexel Unversity (BS) / LaSalle University (MBA)
BS/MBA
Drexel University
BS (Mechanical Engineering)
La Salle University
MBA
The Quantic Group, Ltd July 2010 - Present
LCZ Validation & Consulting Services July 2010 - October 2010
ProPharma Group August 2003 - May 2009
SAIC-Frederick, Inc. 2004 - 2008
Day & Zimmermann Validation Services 1998 - 2003
Raytheon Engineers and Constructors (RE&C) 1990 - 1996
Skills
Validation, V&V, Biotechnology, Medical Devices, Project Management, Management, FDA, Pharmaceutical Industry, Change Control, 21 CFR Part 11, GMP, CAPA, Quality System, SOP, Technology Transfer, Biopharmaceuticals
Education
Ocean County College 1980 — 1984
Validant 2013 - Present
The Quantic Group Ltd. November 2011 - February 2013
Genzyme 2011 - 2013
The Quantic Group 2011 - 2013
Celgene Corporation November 2007 - June 2011
Watson Pharmaceuticals March 2003 - November 2007
Wyeth 1999 - 2003
Baxter International Inc. 1999 - 2003
Marsam Pharmaceuticals, Cherry Hill, NJ 1999 - 1999
Molecular Biosystems, Inc., San Diego, CA 1997 - 1998
Skills
Technology Transfer, Cleaning Validation, Project Management, GMP, GxP, Sop, 21 CFR Part 11, Validation, Computer System..., Aseptic Processing, GAMP, Biopharmaceuticals, Biotechnology, CAPA, LIMS, GLP, Lifesciences, Change Control, Process Validation, Remediation, V&V, Pharmaceutical Industry, Regulatory Requirements, SOP, Life Sciences, Quality Assurance, FDA
Education
Far Eastern University 1976 — 1979
Zoology
Far Eastern University 1976 — 1979
University of Santo Tomas 1974 — 1976
General
Saint Louis University (PH) 1970 — 1974
Saint Louis University (PH) 1970 — 1974
Intarcia Therapeutics July 2014 - Present
The Quantic Group, Ltd July 2011 - Present
Genentech 2009 - 2011
Gilead Sciences July 2007 - July 2009
MedImmune 2003 - 2007
The University of Chicago 1997 - 2000
Skills
Project Management, Automation, Maximo, Program Management, Quality Assurance, CAPA, V&V, Validation, Computer System..., GAMP, S88, S95, Emerson DeltaV, PI Data Historian, OSIsoft PI, Data Historian, SAP Project Management, Pharmaceutical Industry, FDA, GMP, Biotechnology, 21 CFR Part 11, SOP, Change Control, Biopharmaceuticals
Education
University of Chicago
Ph.D., Linguistics / Slavic Linguistics
University of California, Los Angeles
MLS, Information Systems
New York University 1988 — 1988
Cert., Filmmaking
Hinsdale Central High School
University of California, Santa Barbara
BA, CSLit
Univerzita Karlova v Praze
Fullbright Dissertation Research Fellow, History / Linguistics / Czech
SummitConsulting,Inc. January 2006 - Present
The Center for Professional Innovation and Education March 2008 - Present
The Quantic Group, LTD January 2006 - Present
Center for Professional Innovation and Education Advisory Board March 2013 - Present
Webinar Course Instructor August 2010 - December 2014
Hunters Ridge Townhouse Homeowners Association 2004 - 2010
Merck & Co., Inc. May 1977 - June 2005
Skills
GMP, cGMP, Pharmaceuticals, CAPA, Quality Systems, FDA, Training, Eudralex, SOP development, Quality Assurance, Quality Auditing, Property Management, Investment Properties, Electricians, Plumbing, Laminate Flooring, Renovation, 21 CFR, Software Documentation, Quality System, Pharmaceutical Industry, Quality Management, Sop, Validation, Change Control, Quality Control, Regulatory Submissions, Regulatory Affairs, Pharmaceutics, GLP, 21 CFR Part 11, LIMS, V&V, Vaccines, Regulatory Requirements, Auditing, Lifesciences, Process Simulation, Protocol, Chromatography, Microbiology, Biopharmaceuticals, Analytical Chemistry, Clinical Trials, GCP, HPLC, Root Cause Analysis, Medical Devices, R&D, Chemistry
Education
James Madison University 1973 — 1977
Bachelor’s Degree, Chemistry
The Quantic Group, Ltd. 2000 - Present
Hazleton Laboratories Inc February 1988 - June 1991
Adria Laboratories August 1974 - September 1987
Education
University of Missouri-Kansas City 1962 — 1966
Bertram J. Marcus LLC 2003 - Present
The Quantic Group, Ltd. 2002 - Present
Skills
Validation, GLP, V&V, Biotechnology, Vaccines, Cleaning Validation, Medical Devices, Quality Control, Project Management, GxP, Quality Auditing, Pharmaceutics, R&D, Computer System..., LIMS, cGMP, Operational Due..., vitamins, dosage forms
Education
Brooklyn College, MA, Chemistry 1968 — 1971
Master of Arts (M.A.), Analytical Chemistry
City University of New York-Brooklyn College 1966 — 1971
BS, MA, Chemistry
McNeil Consumer Healthcare January 2013 - Present
The Quantic Group, LTD February 2004 - Present
Genzyme June 2011 - November 2012
The Quantic Group, Ltd February 2008 - July 2011
Ben Venue Laboratories 2008 - 2011
DuPont Pharmaceuticals 1998 - 1999
DuPont Pharmaceuticals 1998 - 1999
Skills
Validation, Method Development, Industrial Microbiology, Pharmaceutical..., Microbiologists, Quality Assurance, Quality Control, Water Quality, Quality Auditing, Batch Records, Protocol, Mentoring, Cleaning Validation, Validating, Environmental Consulting, Consultants, Investigation, Deviations, Aseptic Processing, Non-Sterile..., GMP, Microbiology, V&V, CAPA, Change Control, GxP, FDA, Pharmaceutical Industry, Analytical Chemistry, Biotechnology, GLP, Sop, Technology Transfer, Regulatory Requirements, Computer System..., Quality System, Regulatory Affairs, Regulatory Submissions, GAMP, ISO 13485, Pharmaceutics, Lifesciences, Biopharmaceuticals, Laboratory, Vaccines, Life Sciences
Education
University of Puerto Rico 1999 — 1999
Industrial Microbiology, Microbiology
Pontifical Catholic University 1990 — 1995
Major in Biology
EINIG & ASSOCIATES, INC. January 2002 - Present
EINIG & ASSOCIATES, Inc. January 2002 - Present
The Quantic Group, Ltd 2002 - Present
The Center for Professional Advancement 2002 - Present
Sandoz 2002 - 2004
Biopure 2002 - 2004
Johnson-Matthey 1998 - 2001
Skills
FDA, GMP
Education
University of Missouri-Columbia 1981 — 1984
Outsource, Inc. 1995 - Present
The Quantic Group, Ltd. 1998 - Present
Lee's Summit Equestrian 2014 - Present
BES Company, Inc. 1991 - 1995
Marion Laboratories 1985 - 1988
Pfizer 1982 - 1985
Phillips Petroleum 1981 - 1982
Skills
Quality Systems Design, Quality System..., Facility Assessment, Equipment Qualification, Utility Systems, Validation, Cleaning Validation, SOP development, Computerized Systems, Calibration, Maintenance, Aseptic Processing, Solid Oral Dosage Forms, Manufacturing Operations, Change Control, 21 CFR Part 11, FDA, Quality System, Manufacturing, Sop, Quality Assurance, GMP, GxP, Pharmaceutical Industry, V&V, Quality Control, GLP, Medical Devices, CAPA, Regulatory Requirements, ISO 13485, Quality Auditing, Maintenance & Repair, SOP, Biopharmaceuticals, Technology Transfer, Computer System...
Education
University of Kansas - Graduate School of Business 1988 — 1991
Master of Business Administration (MBA)
University of Missouri-Rolla 1977 — 1981
Bachelor of Science (B.S.), Chemical Engineering
Quantic 2001 - Present
The Quantic Group, Ltd. 2001 - 2006
Carter-Wallace 1990 - 1994
sanofi-aventis 1981 - 1990
RHÔNE-POULENC RORER INC 1981 - 1990
Revlon Health Care Group/Rorer Pharmaceuticals 1981 - 1990
Education
Rutgers University-New Brunswick 1961 — 1972
Quality Systems Consulting, Inc July 1998 - Present
The Quantic Group, Ltd October 1998 - Present
Meridian Medical Technologies/Survival Technology, Inc. 1994 - 1998
Survival Technology, Inc. 1992 - 1994
Survival Technology, Inc 1986 - 1992
Invitron Corporation, Division of Monsanto Company 1984 - 1986
Survival Technology, Inc 1976 - 1984
Skills
Validation, Biotechnology, Quality System, Change Management, Medical Devices, Marketing Strategy, Start-ups, Strategic Planning, FDA, Pharmaceutical Industry, Aseptic Processing, CAPA, Quality Assurance, Change Control, Quality Control, GMP, SOP, Technology Transfer, Regulatory Affairs
Education
Southern Illinois University, Edwardsville 1973 — 1997
Master of Business Administration (M.B.A.), BA in Science and Technology
The Quantic Group, Ltd. 1997 - Present
H. C Stober Consultants, Inc. 1993 - Present
Ciba - Geigy 1958 - 1993
Skills
FDA, Pharmaceutical Industry, GMP, Validation, V&V, Technology Transfer, 21 CFR Part 11, Change Control, Biotechnology, GLP, Quality Assurance, Sop, CAPA, Quality System, Regulatory Affairs, Computer System..., Analytical Chemistry, GxP, Regulatory Requirements, Regulatory Submissions, LIMS, Quality Control, Pharmaceutics, Quality Auditing, Laboratory, Lifesciences, SOP, Biopharmaceuticals
Education
Seton Hall University 1966 — 1971
PhD, Analytical Chemistry
City University of New York City College 1953 — 1958
BS, Chemistry
The Quantic Group, Ltd. overseerBoston Symphony Orchestra2005 - 2010
Boston Symphony Orchestra 2005 - 2010
Boston Symphony Orchestra 2005 - 2010
Skills
Strategic Planning, Technology Transfer, Medical Devices, Change Control, Validation, GMP, Quality Auditing, FDA, Project Management, Regulatory Affairs, Leadership, Consent Decree, Cross-functional Team..., 21 CFR Part 11, Quality System, Computer System..., Lifesciences, Training, Pharmaceutical Industry, PowerPoint, Contract Negotiation, Management, Business Strategy, CAPA, Commercialization, Customer Service, Change Management, Quality Assurance, Regulatory Submissions, Biotechnology, Quality Control, Organizational..., Manufacturing, Sop, Regulatory Requirements, Strategy, GLP, Quality Management, Microsoft Office, Pharmaceutics, V&V, GxP, Coaching, R&D, Microsoft Excel, Research, Biopharmaceuticals, Microsoft Word, Project Planning, Technical Writing
Education
Georgia Institute of Technology
The Quantic Group, Ltd August 2010 - Present
The Quantic Group LTD August 2010 - January 2011
The Quantic Group LTD 2001 - 2008
Ciba-Geigy 1992 - 1999
Education
Long Island University 1981 — 1985
Msc./MBA, Clinical Chemistry/ BusinessAdministration
City University of New York 1968 — 1972
Bsc., Biochemistry
ZOHAR Biotech, LLC January 1998 - Present
Quantic Regulatory Services, LLC April 2011 - August 2013
Talecris Biotherapeutics August 2007 - January 2008
The Quantic Group, Ltd August 2000 - February 2007
Stelex, Inc. January 1999 - December 1999
American Red Cross National Testing Laboratory January 1994 - May 1998
BioTransplant, Inc. 1993 - January 1994
Hybridon, Inc. 1991 - 1993
Biotechnology General, Ltd 1986 - 1989
Skills
Biotechnology, FDA, Quality Systems, cGMP, Regulatory Affairs, Biochemistry, GLP, Protein Chemistry, Pharmaceuticals, Plant Physiology, R&D, Validation, Quality Assurance, Science, Start-ups, Blood & Plasma Industry, Analytical Chemistry, Contract Management, Blood, Quality System, Pharmaceutical Industry, GMP, Computer System..., CAPA, Sop, Clinical Development, V&V, Technology Transfer, Quality Control, Medical Devices, Lifesciences, 21 CFR Part 11, HPLC
Education
Weizmann Institute of Science 1970 — 1975
Ph.D., Biochemistry
The Hebrew University 1969 — 1970
M.Sc., Physical Chemistry
The Hebrew University 1967 — 1969
B.Sc., Chemistry
The Quantic Group, Ltd. July 2011 - Present
MARKI Consultants, LLC August 2007 - Present
Lachman Consultants Ltd September 2007 - May 2010
Meretek Diagnostics, Inc. 2003 - 2007
Corgenix, Inc. September 2001 - January 2003
Sandoz August 1985 - March 2001
Skills
GLP, Product Launch, FDA, ISO 13485, Change Control, V&V, Sop, Quality Assurance, Quality System, Regulatory Requirements, IND, Regulatory Submissions, Validation, Clinical Development, GMP, Technology Transfer, Medical Devices, Pharmaceutical Industry, GxP, 21 CFR Part 11, Regulatory Affairs, Quality Control, Quality Auditing, Laboratory, GAMP, GCP, FDA GMP, Lifesciences, Trackwise, Biopharmaceuticals, HPLC, Biotechnology, LIMS, Computer System..., CAPA
Education
University of San Francisco 1964 — 1968
B.A., Majors: Chemistry, French
The Quantic Group Ltd February 2011 - Present
Pfizer November 2009 - February 2011
Wyeth 2007 - 2009
Wyeth Research 2003 - 2007
Wyeth Research 1997 - 2003
Lederle Laboratories 1993 - 1997
Schein Pharmaceuticals 1988 - 1993
Skills
Drug Development, Formulation, Process Optimization, Quality by Design, Scale-up, Technology Transfer, Validation, Design of Experiments, cGMP manufacturing, Compliance, Internal Audit, Quality System, Risk Assessment, ANDA, GMP, Quality Auditing, Regulatory Submissions, Cleaning Validation, CAPA, IND, Process Simulation, Analytical Chemistry, 21 CFR Part 11, R&D, Clinical Trials, Life Sciences
Education
Saint John's University 1993 — 1997
Ph.D., Industrial Pharmacy
University of Cincinnati 1986 — 1988
Master of Science (MS), Industrial and Physical Pharmacy and Cosmetic Sciences
Andhra University
M.Pharm, Pharmaceutics & Fermentation Technology
Andhra University
B.Pharm, Pharmacy
WLU Consulting, LLC 1999 - Present
The Quantic Group, LTD 2012 - 2012
Bukovac & Duncan Technology Group 2010 - 2012
IPS 2007 - 2010
D.H. Gold Associates 2001 - 2007
Par Pharmaceuticals, Inc. 1997 - 2000
Barr Laboratories 1996 - 1997
Lederle Laboratories 1993 - 1996
Lederle Laboratories 1990 - 1993
Lederle Laboratories 1984 - 1990
Skills
Validation, 21 CFR Part 11, Computer System..., Change Control, Pharmaceutical Industry, GMP, GxP, Biotechnology, FDA, GAMP, CAPA
Education
Fairleigh Dickinson University
Bachelor of Science (BSc), Mechanical Engineering
Long Island University
Master program, Industrial Pharmacy
Virginia Tech
Bachelor of Arts (B.A.), History
Highlawn Pavilion September 2014 - March 2015
The Quantic Group, Ltd January 2014 - June 2014
Rothstein Kass & Company, P.C. January 2011 - May 2013
Dr. Carl Pfeffer April 2009 - January 2011
White & Case LLP 2003 - 2009
KPMG Corporate Finance 1998 - 2003
Skills
Management, Human Resources, Research, Microsoft Excel, Vendor Management, Administrative..., PowerPoint, Lotus Notes, Nonprofits, Benefits Administration, HRIS, Employee Relations, Outlook, Public Speaking, Recruiting, Employee Benefits, Office Management, Access, Training, Accounting, Administrative...
Education
State University of New York Empire State College 2009 — 2011
Business/Managerial Economics
Iona College 1994 — 1995
Computer Science
Grace Institute
Administrative/Business
The Quantic Group, Ltd May 2011 - Present
Quality Etc. Consulting, LLC 1999 - Present
Pharmaceutical Company September 2013 - December 2014
Genzyme May 2011 - September 2013
Sandoz Pharmaceuticals January 2009 - August 2009
Tunnell Consulting 1999 - 2009
MDS Pharma Services 2005 - 2007
Watson Pharmaceuticals 2003 - 2005
Watson Pharmaceuticals 2002 - 2003
Abbott Diagnostics 1999 - 2000
Skills
FDA, Consulting, GMP, Management, CAPA, Pharmaceutical Industry, 21 CFR Part 11, Change Control, Quality System, Regulatory Affairs, Sop, Technology Transfer, Validation, Biotechnology, GLP, SOP, V
Education
Rutgers, The State University of New Jersey-Newark 1988 — 1990
MS, Biological Sciences
The Quantic Group, Ltd January 2011 - Present
Tunnell Consulting, Inc January 2006 - December 2010
Cardinal Health 2000 - 2005
Alpharma 1989 - 2000
Education
The Johns Hopkins University
M.A.S., Business and Behavioral Management
Towson University
B.S., Biology, Chemistry
The Quantic Group, Ltd May 2011 - December 2013
Pfizer Pharmaceuticals September 2008 - June 2010
Wyeth Research January 2008 - August 2008
Wyeth Reasearch June 1998 - December 2007
Wyeth Research July 1988 - June 1998
Skills
Process Engineering, Project Management, Management, Business Analysis, Control Theory
Education
Iona College 2001 — 2005
MBA, management
Albany College of Pharmacy of Union University 1983 — 1988
BS, Pharmacy
Right management class
Chiltern May 2015 - Present
ClinTec International February 2014 - April 2015
Palatin Technologies, Inc March 2008 - July 2013
The Quantic Group, Ltd. January 2010 - September 2011
Amicus Therapeutics, Inc January 2009 - November 2009
INTEGRA LifeSciences Corporation October 2007 - March 2008
Palatin Technologies Inc August 2005 - October 2006
ConvaTec February 2003 - July 2005
NexMed, Inc September 2001 - January 2003
Kimball Medical Center December 1991 - August 2001
Skills
Clinical, Clinical Trials, Clinical Research, Clinical Operations, GCP, Protocol, CRO, Clinical Development, ICH-GCP, Clinical Monitoring, CTMS, EDC, Regulatory Submissions, Sop, Therapeutic Areas, Pharmaceutical Industry, SOP
Education
University of Delaware
Bachelor of Science, Nursing
Ocean County College
Associate Degree, Nursing
The Quantic Group, Ltd. January 2001 - Present
Quantic 2001 - Present
Skills
Auditing, Quality System, Software Documentation, Medical Devices, 21 CFR Part 11, CAPA, Change Control, Pharmaceutical Industry, Sop, Quality Assurance, GMP, FDA, Spreadsheets, LIMS, Process Improvement, Continuous Improvement, Quality Management, Computer System..., Accounts Receivable, Manufacturing, Validation, GxP, GLP, Quality Control, Cleaning Validation, Quality Auditing, Invoicing, Technology Transfer, Change Management, Biotechnology, Accounts Payable, Document Management
Education
Rutgers, The State University of New Jersey-New Brunswick 1998 — 2001
The Quantic Group, Ltd. July 2011 - Present
Bristol-Myers Squibb, New Brunswick, New Jersey February 2002 - December 2010
Bristol-Myers Squibb, New Brunswick, New Jersey January 1999 - November 2002
Skills
GMP, Technology Transfer, FDA, Pharmaceutical Industry, CAPA, Change Control, Regulatory Requirements, Biotechnology, Quality Assurance, Change Management, Biopharmaceuticals, Quality System, Manufacturing, Process Improvement, Sop, Validation, GxP, Regulatory Affairs, 21 CFR Part 11, Cross-functional Team..., Computer System..., V&V, LIMS
Education
Rutgers, The State University of New Jersey-New Brunswick 1978 — 1980
BS, Biological Sciences
Walmart June 2015 - Present
Walmart Pharmacy May 2012 - May 2015
The Quantic Group, Ltd July 2010 - August 2011
University of Miami Wellness Center January 2008 - May 2011
Skills
Healthcare, Cpr Certified, Clinical Research
Education
Belmont University College of Pharmacy 2011 — 2015
Doctor of Pharmacy (Pharm.D.)
University of Miami 2007 — 2011
Bachelor of Science (BS), Health Science
The Quantic Group, Ltd 2011 - 2014
Skills
Pharmaceutical Industry, Quality Assurance, Validation, Change Control, Technology Transfer
Education
University of Missouri-Columbia
Bachelor's Degree, Clinical Laboratory Science/Medical Technology/Technologist
University of Nebraska-Lincoln
Master's Degree, Microbiology, General
Hill Wallack LLP May 2015 - August 2015
Sadaka Associates LLC August 2014 - April 2015
Monmouth County Courthouse June 2014 - August 2014
The Quantic Group, Ltd February 2012 - August 2013
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Public Speaking, Research, Social Media, Social Networking, Time Management, Event Planning
Education
Rutgers University School of Law - Newark 2013 — 2016
Rutgers University-New Brunswick 2008 — 2012
Bachelor of Arts (B.A.), Political Science/Labor Studies and Employment Relations