Swiss Caps USA
Industry: Company
DescriptionFounded: 1994 Parent organization: Aenova Group GmbH
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Swiss Caps USA Employees
Employee
Years
Job
Industry
Javier Guandalini Javier Guandalini's Swiss Caps USA Experience May 2001 - February 2007
Job
Industry Medical Devices
Experience
Interbeverage, LLC May 2012 - June 2013
PLDevelopments, Inc June 2009 - April 2012
Azopharma Contract Services February 2007 - June 2009
Swiss Caps, USA May 2001 - February 2007
Skills
Six Sigma, Manufacturing, Lean Manufacturing, Sop, 5S, Business Process..., Formulation, Product Development, Pharmaceutics, Validation, GLP, Technology Transfer, FDA GMP, HPLC, Analytical Chemistry, Quality Auditing, SOP development, CAPA, Quality System, FDA, GMP, Pharmaceutical Industry, Change Control, 21 CFR, Design Control, ISO 13485, Quality Management, Medical Devices, 21 CFR Part 11, Quality Assurance, CQA, Minitab, SOP
Education
W.G University Utha
Bachelor of Applied Science (BASc), Operations Management
Miami Dade College
Industrial Enginerring, Operations Management
National School Tech. Ed.
Industrial Chemical Research, Pharmaceutical Sciences
Interbeverage, LLC May 2012 - June 2013
PLDevelopments, Inc June 2009 - April 2012
Azopharma Contract Services February 2007 - June 2009
Swiss Caps, USA May 2001 - February 2007
Skills
Six Sigma, Manufacturing, Lean Manufacturing, Sop, 5S, Business Process..., Formulation, Product Development, Pharmaceutics, Validation, GLP, Technology Transfer, FDA GMP, HPLC, Analytical Chemistry, Quality Auditing, SOP development, CAPA, Quality System, FDA, GMP, Pharmaceutical Industry, Change Control, 21 CFR, Design Control, ISO 13485, Quality Management, Medical Devices, 21 CFR Part 11, Quality Assurance, CQA, Minitab, SOP
Education
W.G University Utha
Bachelor of Applied Science (BASc), Operations Management
Miami Dade College
Industrial Enginerring, Operations Management
National School Tech. Ed.
Industrial Chemical Research, Pharmaceutical Sciences
George Toth George Toth's Swiss Caps USA Experience September 2009 - February 2013
Job Director of Quality Assurance at TherapeuticsMD
Industry Pharmaceuticals
Experience
TherapeuticsMD December 2014 - Present
NBTY February 2013 - December 2014
Swiss Caps USA September 2009 - February 2013
Abbott Laboratories November 2006 - August 2009
Kos Pharmaceuticals February 2003 - October 2006
Kos Pharmaceuticals, Inc. April 1995 - January 2003
Kos Pharmaceuticals, Inc. October 1990 - April 1995
Materials Processing Technology, Inc (MPT) September 1989 - October 1990
Vitarine Pharmaceuticals 1988 - 1989
Skills
CAPA, Sop, Validation, FDA, Pharmaceutical Industry, Cleaning Validation, GMP, Quality Assurance, Quality Control, Pharmaceutics, 21 CFR Part 11, Regulatory Affairs, GLP, Change Control, Quality System, Technology Transfer, Laboratory
Education
Ursinus College 1984 — 1988
Bachelor of Science, Analytical Chemistry, Biology, Anthropology
Florida International University
TQM Certification, Quality Management
Keller Graduate School of Management of DeVry University
MBA, Business and Human Resources
TherapeuticsMD December 2014 - Present
NBTY February 2013 - December 2014
Swiss Caps USA September 2009 - February 2013
Abbott Laboratories November 2006 - August 2009
Kos Pharmaceuticals February 2003 - October 2006
Kos Pharmaceuticals, Inc. April 1995 - January 2003
Kos Pharmaceuticals, Inc. October 1990 - April 1995
Materials Processing Technology, Inc (MPT) September 1989 - October 1990
Vitarine Pharmaceuticals 1988 - 1989
Skills
CAPA, Sop, Validation, FDA, Pharmaceutical Industry, Cleaning Validation, GMP, Quality Assurance, Quality Control, Pharmaceutics, 21 CFR Part 11, Regulatory Affairs, GLP, Change Control, Quality System, Technology Transfer, Laboratory
Education
Ursinus College 1984 — 1988
Bachelor of Science, Analytical Chemistry, Biology, Anthropology
Florida International University
TQM Certification, Quality Management
Keller Graduate School of Management of DeVry University
MBA, Business and Human Resources
Cecil Navajas's Swiss Caps USA Experience April 2000 - August 2003
Job QA Manager at Cordis Corp. a J&J Co.
Industry Medical Devices
Experience
Cordis Corporation, a Johnson & Johnson Company August 2003 - Present
Florida International University January 1997 - December 2010
Swiss Caps USA April 2000 - August 2003
Swiss Caps USA April 1998 - April 2000
Pios & Sons Entrerprises April 1996 - April 1998
University of Kuopio, FInland March 1994 - March 1996
University of Havana, Cuba September 1975 - March 1994
Skills
CAPA, FDA, GMP, ISO 13485, Medical Devices, Quality System, Design Control, Pharmaceutical Industry, GLP, Sop, Chemistry, Kaizen, Validation, Six Sigma, Value Stream Mapping, DMAIC, Regulatory Affairs, Quality Assurance, Quality Control, Microbiology, ISO, Laboratory, Quality Auditing, 21 CFR Part 11, Regulatory Requirements, Change Control, Pharmaceutics, R&D
Education
University of Eastern Finland 1994 — 1996
PhD, Pharmaceutical Chemistry
Havana University 1970 — 1975
Bachelor, Pharmaceutical Chemistry
Cordis Corporation, a Johnson & Johnson Company August 2003 - Present
Florida International University January 1997 - December 2010
Swiss Caps USA April 2000 - August 2003
Swiss Caps USA April 1998 - April 2000
Pios & Sons Entrerprises April 1996 - April 1998
University of Kuopio, FInland March 1994 - March 1996
University of Havana, Cuba September 1975 - March 1994
Skills
CAPA, FDA, GMP, ISO 13485, Medical Devices, Quality System, Design Control, Pharmaceutical Industry, GLP, Sop, Chemistry, Kaizen, Validation, Six Sigma, Value Stream Mapping, DMAIC, Regulatory Affairs, Quality Assurance, Quality Control, Microbiology, ISO, Laboratory, Quality Auditing, 21 CFR Part 11, Regulatory Requirements, Change Control, Pharmaceutics, R&D
Education
University of Eastern Finland 1994 — 1996
PhD, Pharmaceutical Chemistry
Havana University 1970 — 1975
Bachelor, Pharmaceutical Chemistry
Linda Hernandez's Swiss Caps USA Experience June 2014 - Present
Job Quality Assurance & Compliance Manager at Swiss Caps USA
Industry Pharmaceuticals
Experience
Swiss Caps USA June 2014 - Present
Reserveage Organics July 2013 - June 2014
NBTY June 2012 - June 2013
STR-Registrar, LLC July 2011 - June 2012
Nature's Products Inc February 2009 - July 2011
Schering-Plough November 2004 - November 2008
Arnet Pharmaceutical November 2003 - November 2004
NBTY 1998 - 2003
Bristol-Myers Squibb, Puerto Rico December 1992 - June 1998
Skills
CAPA, FDA, Quality Management, Quality Assurance, GMP, Validation, Change Control, Sop, Quality System, V&V, Lean Manufacturing, Regulatory Affairs, Quality Control, 21 CFR Part 11, Quality Auditing, Manufacturing, GLP, FDA GMP, Cleaning Validation, Root Cause Analysis, GxP, ISO, Regulatory Requirements, LIMS, ISO 13485, Technology Transfer, Computer System..., Analytical Chemistry, Trackwise, SOP, TrackWise
Education
University of Phoenix 1995 — 1996
MBA, Management
Universidad de Puerto Rico 1976 — 1980
BS, Chemistry
Swiss Caps USA June 2014 - Present
Reserveage Organics July 2013 - June 2014
NBTY June 2012 - June 2013
STR-Registrar, LLC July 2011 - June 2012
Nature's Products Inc February 2009 - July 2011
Schering-Plough November 2004 - November 2008
Arnet Pharmaceutical November 2003 - November 2004
NBTY 1998 - 2003
Bristol-Myers Squibb, Puerto Rico December 1992 - June 1998
Skills
CAPA, FDA, Quality Management, Quality Assurance, GMP, Validation, Change Control, Sop, Quality System, V&V, Lean Manufacturing, Regulatory Affairs, Quality Control, 21 CFR Part 11, Quality Auditing, Manufacturing, GLP, FDA GMP, Cleaning Validation, Root Cause Analysis, GxP, ISO, Regulatory Requirements, LIMS, ISO 13485, Technology Transfer, Computer System..., Analytical Chemistry, Trackwise, SOP, TrackWise
Education
University of Phoenix 1995 — 1996
MBA, Management
Universidad de Puerto Rico 1976 — 1980
BS, Chemistry
Gisele Atkinson's Swiss Caps USA Experience 2005 - 2006
Job Director of Quality at Renew Life Formulas, Inc.
Industry Health, Wellness and Fitness
Experience
Renew Life October 2009 - Present
New Chapter, Inc. 2006 - 2009
Swiss Caps USA 2005 - 2006
Atlantis Foods 2004 - 2004
Rexall Sundown/NBTY 2000 - 2004
Skills
Quality System, FDA, Quality Assurance, CAPA, Validation, Quality Control, Manufacturing, Change Control, Supplements, Biotechnology, SOP, FDA GMP, Microbiology, GMP, Cross-functional Team..., CQA, Auditing, SOP development, FDA Audit
Education
University of Guelph 1991 — 1996
BSc, Microbiology/Biotechnology
Renew Life October 2009 - Present
New Chapter, Inc. 2006 - 2009
Swiss Caps USA 2005 - 2006
Atlantis Foods 2004 - 2004
Rexall Sundown/NBTY 2000 - 2004
Skills
Quality System, FDA, Quality Assurance, CAPA, Validation, Quality Control, Manufacturing, Change Control, Supplements, Biotechnology, SOP, FDA GMP, Microbiology, GMP, Cross-functional Team..., CQA, Auditing, SOP development, FDA Audit
Education
University of Guelph 1991 — 1996
BSc, Microbiology/Biotechnology
Angela Bowman's Swiss Caps USA Experience February 2012 - July 2012
Job Senior Manager, Business Development at Aenova
Industry Pharmaceuticals
Experience
Aenova October 2012 - Present
Contract Pharmacal Corp July 2012 - September 2012
Swiss Caps USA February 2012 - July 2012
Swiss Caps USA October 2010 - February 2012
Swiss Caps USA July 2007 - October 2010
PAL Laboratories, Inc. January 2006 - July 2007
Banner Pharmacaps July 2001 - December 2005
Banner Pharmacaps March 1999 - July 2001
Novartis Animal Health May 1997 - March 1999
CMS, Inc. February 1996 - May 1997
Skills
Leadership, Validation, Business Development, GMP, Marketing Strategy, Pharmaceutical Industry, Customer Service, R&D, Biotechnology, Product Development, Sop, Negotiation, Strategy, New Business Development, Operations Management, Regulatory Affairs, Sales Management, FDA, Strategic Planning, P&L Management, Cross-functional Team..., Ingredients, Nutraceuticals
Education
North Carolina State University
Engineering
Salem College
Bachelor of Arts (B.A.), Mathematics
Aenova October 2012 - Present
Contract Pharmacal Corp July 2012 - September 2012
Swiss Caps USA February 2012 - July 2012
Swiss Caps USA October 2010 - February 2012
Swiss Caps USA July 2007 - October 2010
PAL Laboratories, Inc. January 2006 - July 2007
Banner Pharmacaps July 2001 - December 2005
Banner Pharmacaps March 1999 - July 2001
Novartis Animal Health May 1997 - March 1999
CMS, Inc. February 1996 - May 1997
Skills
Leadership, Validation, Business Development, GMP, Marketing Strategy, Pharmaceutical Industry, Customer Service, R&D, Biotechnology, Product Development, Sop, Negotiation, Strategy, New Business Development, Operations Management, Regulatory Affairs, Sales Management, FDA, Strategic Planning, P&L Management, Cross-functional Team..., Ingredients, Nutraceuticals
Education
North Carolina State University
Engineering
Salem College
Bachelor of Arts (B.A.), Mathematics
Zhao Xu's Swiss Caps USA Experience 2006 - 2008
Job Sr. Scientist at Noven Pharmaceuticals
Industry Pharmaceuticals
Experience
Noven Pharmaceuticals June 2008 - Present
Swiss Caps USA 2006 - 2008
Ivax Research Inc. 2001 - 2006
ICI PU China 1994 - 1997
Education
Florida International University
MS, Chemistry
High School
Noven Pharmaceuticals June 2008 - Present
Swiss Caps USA 2006 - 2008
Ivax Research Inc. 2001 - 2006
ICI PU China 1994 - 1997
Education
Florida International University
MS, Chemistry
High School
Nick Bain's Swiss Caps USA Experience August 1995 - March 1997
Job Vice President of Sales at TR Nutritionals
Industry Health, Wellness and Fitness
Experience
TR Nutritionals July 2005 - Present
BI Nutraceuticals_ Zeullig Group NA June 2000 - June 2005
Zetapharm_ Zeullig Group NA June 1997 - June 2000
Swiss Caps USA August 1995 - March 1997
IVAX November 1993 - August 1995
Pelican Airways March 1991 - December 1994
Skills
Cross-functional Team..., Pharmaceutical Industry, Product Development, Nutraceuticals, New Business Development, Sales Management, Sales Operations, Forecasting
Education
Edinburgh Napier University
BSc, Life Sciences
TR Nutritionals July 2005 - Present
BI Nutraceuticals_ Zeullig Group NA June 2000 - June 2005
Zetapharm_ Zeullig Group NA June 1997 - June 2000
Swiss Caps USA August 1995 - March 1997
IVAX November 1993 - August 1995
Pelican Airways March 1991 - December 1994
Skills
Cross-functional Team..., Pharmaceutical Industry, Product Development, Nutraceuticals, New Business Development, Sales Management, Sales Operations, Forecasting
Education
Edinburgh Napier University
BSc, Life Sciences
Carlyne Belot's Swiss Caps USA Experience 2003 - 2005
Job Experienced Procurement Professional
Industry Health, Wellness and Fitness
Experience
Nature's Products, Inc. March 2012 - Present
Johnson & Johnson January 2008 - March 2010
Leiner Health Products 2006 - 2008
Swiss Caps USA 2003 - 2005
Skills
Product Development, Cross-functional Team..., Forecasting, Pharmaceutical Industry, Supply Chain, Manufacturing, SAP, Management, MRP, GMP, Strategic Planning, Account Management, Sales, Strategic Sourcing, Key Account Management, Inventory Management, Purchasing, Sales Operations, Six Sigma, Contract Negotiation, Process Improvement, Lean Manufacturing, Continuous Improvement, Market Analysis, Procurement, Project Planning, Quality System, Global Sourcing, Logistics, Customer Service, Competitive Analysis, Consumer Products, Sourcing, Negotiation, Leadership, Supply Chain Management
Education
Florida International University
BS, Public Relations, Marketing
Nature's Products, Inc. March 2012 - Present
Johnson & Johnson January 2008 - March 2010
Leiner Health Products 2006 - 2008
Swiss Caps USA 2003 - 2005
Skills
Product Development, Cross-functional Team..., Forecasting, Pharmaceutical Industry, Supply Chain, Manufacturing, SAP, Management, MRP, GMP, Strategic Planning, Account Management, Sales, Strategic Sourcing, Key Account Management, Inventory Management, Purchasing, Sales Operations, Six Sigma, Contract Negotiation, Process Improvement, Lean Manufacturing, Continuous Improvement, Market Analysis, Procurement, Project Planning, Quality System, Global Sourcing, Logistics, Customer Service, Competitive Analysis, Consumer Products, Sourcing, Negotiation, Leadership, Supply Chain Management
Education
Florida International University
BS, Public Relations, Marketing
Rozelle Smith, MSQSM, CQA's Swiss Caps USA Experience 2006 - 2007
Job Director of QA at ECI Pharmaceuticals LLC
Industry Pharmaceuticals
Experience
HeartWare Inc February 2011 - March 2015
QRCC Consulting March 2009 - August 2012
Nautilus Water Co. Ltd. 2008 - 2009
Swiss Caps USA 2006 - 2007
Watson Pharmaceuticals (formerly Andrx Pharmaceuticals) 2002 - 2006
Centers for Disease Control, National Center for Environmental Health 2002 - 2002
Centers for Disease Control, National Center for Environmental Health 2001 - 2001
Skills
USP, Training, LIMS, CAPA, FDA GMP, Root Cause Analysis, CQA, ISO 13485, Lifesciences, Quality Assurance, Validation, Quality Auditing, Quality Control, Change Control, Medical Devices, GxP, GMP, Regulatory Affairs, 21 CFR Part 11, Quality System, HPLC, GCP, Sop, Quality Management, Document Management, GAMP, R&D, Clinical Development, Aseptic Processing, Analytical Chemistry, Cross-functional Team..., 21 CFR, Pharmaceutics, V&V, Raw Materials, Manufacturing, ISO, Process Improvement, Software Documentation, Design Control, Laboratory, Regulatory Requirements, Biotechnology, Deviations, Pharmaceutical Industry, Regulatory Submissions, Chromatography, Trackwise, FDA, Biopharmaceuticals
Education
The National Graduate School of Quality Management (NGS) 2013 — 2014
Master's Degree
Florida Memorial University 1998 — 2001
Bachelor of Science Degree
Akademia Medyczna w Warszawie
HeartWare Inc February 2011 - March 2015
QRCC Consulting March 2009 - August 2012
Nautilus Water Co. Ltd. 2008 - 2009
Swiss Caps USA 2006 - 2007
Watson Pharmaceuticals (formerly Andrx Pharmaceuticals) 2002 - 2006
Centers for Disease Control, National Center for Environmental Health 2002 - 2002
Centers for Disease Control, National Center for Environmental Health 2001 - 2001
Skills
USP, Training, LIMS, CAPA, FDA GMP, Root Cause Analysis, CQA, ISO 13485, Lifesciences, Quality Assurance, Validation, Quality Auditing, Quality Control, Change Control, Medical Devices, GxP, GMP, Regulatory Affairs, 21 CFR Part 11, Quality System, HPLC, GCP, Sop, Quality Management, Document Management, GAMP, R&D, Clinical Development, Aseptic Processing, Analytical Chemistry, Cross-functional Team..., 21 CFR, Pharmaceutics, V&V, Raw Materials, Manufacturing, ISO, Process Improvement, Software Documentation, Design Control, Laboratory, Regulatory Requirements, Biotechnology, Deviations, Pharmaceutical Industry, Regulatory Submissions, Chromatography, Trackwise, FDA, Biopharmaceuticals
Education
The National Graduate School of Quality Management (NGS) 2013 — 2014
Master's Degree
Florida Memorial University 1998 — 2001
Bachelor of Science Degree
Akademia Medyczna w Warszawie
Craig Work's Swiss Caps USA Experience February 2004 - Present
Job Production Manager at Swiss Caps USA
Industry Pharmaceuticals
Experience
Swiss Caps USA February 2004 - Present
Ivax Pharmaceuticals April 1994 - August 1999
Skills
Production Planning, CAPA, Manufacturing Operations, Sop, FDA, Quality System, Pharmaceutical Industry, Lean Manufacturing, Validation, Manufacturing, Cross-functional Team..., LIMS, Operations Management, Inventory Management, Product Development, Pharmaceutical...
Education
Miami Dade College 1991 — 1993
North Bergen Senior High 1989 — 1992
Swiss Caps USA February 2004 - Present
Ivax Pharmaceuticals April 1994 - August 1999
Skills
Production Planning, CAPA, Manufacturing Operations, Sop, FDA, Quality System, Pharmaceutical Industry, Lean Manufacturing, Validation, Manufacturing, Cross-functional Team..., LIMS, Operations Management, Inventory Management, Product Development, Pharmaceutical...
Education
Miami Dade College 1991 — 1993
North Bergen Senior High 1989 — 1992
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