Pharmaceutical Systems Inc
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Pharmaceutical Systems Inc Employees
Employee
Years
Job
Industry
Kesley Gallagher Kesley Gallagher's Pharmaceutical Systems Inc Experience December 2000 - December 2004
Job Senior Manager, Regulatory Affairs at Amgen
Industry Biotechnology
Experience
Amgen January 2013 - Present
Abbott Medical Optics June 2008 - January 2013
Advanced Medical Optics January 2005 - June 2008
Pharmaceutical Systems, Inc December 2000 - December 2004
B. Braun Medical 1995 - 2000
Skills
Medical Devices, FDA, Compliance, Quality Systems, FDA Submissions, CE marking, Pharmaceutical Industry, Design Control, Quality System, Regulatory Submissions, ISO 13485, Product Development, CAPA, GMP, Validation, Change Control, V&V, 21 CFR Part 11, Cross-functional Team..., ISO 14971, Regulatory Affairs, Sop
Education
University of Southern California 2008 — 2010
MS, Regulatory Science
Bowdoin College 1990 — 1994
BA, Biology/Chemistry
Trinity Preparatory School
Amgen January 2013 - Present
Abbott Medical Optics June 2008 - January 2013
Advanced Medical Optics January 2005 - June 2008
Pharmaceutical Systems, Inc December 2000 - December 2004
B. Braun Medical 1995 - 2000
Skills
Medical Devices, FDA, Compliance, Quality Systems, FDA Submissions, CE marking, Pharmaceutical Industry, Design Control, Quality System, Regulatory Submissions, ISO 13485, Product Development, CAPA, GMP, Validation, Change Control, V&V, 21 CFR Part 11, Cross-functional Team..., ISO 14971, Regulatory Affairs, Sop
Education
University of Southern California 2008 — 2010
MS, Regulatory Science
Bowdoin College 1990 — 1994
BA, Biology/Chemistry
Trinity Preparatory School
Kirsten Bishop Kirsten Bishop's Pharmaceutical Systems Inc Experience February 2002 - February 2004
Job Clinical Microbiologist at University of Chicago Medical Center
Industry Hospital & Health Care
Experience
Western Governors University March 2015 - Present
Robert Morris University November 2014 - Present
Purdue University Calumet December 2013 - Present
Alverno Laboratories December 2012 - Present
University of Chicago Medical Center August 2010 - December 2012
Silliker Laboratories, Inc January 2009 - January 2010
Astellas Pharmaceuticals February 2004 - August 2005
Pharmaceutical Systems, Inc February 2002 - February 2004
Case Western Reserve University February 2001 - February 2002
Pharmaceutical Systems Solutions, Inc May 1999 - January 2001
Skills
Laboratory Medicine, Clinical Research, Hospitals, Healthcare, Medical Research, Public Health, Epidemiology, Molecular Biology, Immunology, Microbiology, Cell Culture, PCR, ELISA, Western Blotting, qPCR, RT-PCR, Biochemistry, Microsoft Excel, Microsoft Word, PowerPoint
Education
Rush University 2009 — 2011
MS Science, Clinical Laboratory Science
Southern Illinois University 1997 — 2000
BA, Microbiology
Western Governors University March 2015 - Present
Robert Morris University November 2014 - Present
Purdue University Calumet December 2013 - Present
Alverno Laboratories December 2012 - Present
University of Chicago Medical Center August 2010 - December 2012
Silliker Laboratories, Inc January 2009 - January 2010
Astellas Pharmaceuticals February 2004 - August 2005
Pharmaceutical Systems, Inc February 2002 - February 2004
Case Western Reserve University February 2001 - February 2002
Pharmaceutical Systems Solutions, Inc May 1999 - January 2001
Skills
Laboratory Medicine, Clinical Research, Hospitals, Healthcare, Medical Research, Public Health, Epidemiology, Molecular Biology, Immunology, Microbiology, Cell Culture, PCR, ELISA, Western Blotting, qPCR, RT-PCR, Biochemistry, Microsoft Excel, Microsoft Word, PowerPoint
Education
Rush University 2009 — 2011
MS Science, Clinical Laboratory Science
Southern Illinois University 1997 — 2000
BA, Microbiology
Mark Ratkowski Mark Ratkowski's Pharmaceutical Systems Inc Experience January 2003 - August 2003
Job Supplier Quality Manager at Fisher Clinical Services
Industry Pharmaceuticals
Experience
Fisher Clinical Services February 2015 - Present
Hospira May 2013 - February 2015
Hollister 2010 - May 2013
Hollister July 2007 - 2010
Cardinal Health May 2005 - July 2007
Hospira November 2003 - May 2005
Pharmaceutical Systems, Inc January 2003 - August 2003
Pharmaceutical Systems, Inc April 2002 - January 2003
Northview Laboratories April 1999 - April 2002
Skills
CAPA, GMP, Quality System, Medical Devices, Quality Assurance, ISO 13485, V&V, Quality Control, Microbiology, Sterilization, Contract Manufacturing, Quality Auditing, FDA, Part 820, 21 CFR, Controlled Environments, Environmental Monitoring, Design Control, Laboratory, Change Control, Pharmaceutical Industry, Validation, Clean Rooms, Aseptic Processing, Manufacturing, Sop, SOP
Education
Southern Illinois University, Carbondale 1995 — 1998
BA, Microbiology
Harper College 1993 — 1995
Associates Degree, Science
Fisher Clinical Services February 2015 - Present
Hospira May 2013 - February 2015
Hollister 2010 - May 2013
Hollister July 2007 - 2010
Cardinal Health May 2005 - July 2007
Hospira November 2003 - May 2005
Pharmaceutical Systems, Inc January 2003 - August 2003
Pharmaceutical Systems, Inc April 2002 - January 2003
Northview Laboratories April 1999 - April 2002
Skills
CAPA, GMP, Quality System, Medical Devices, Quality Assurance, ISO 13485, V&V, Quality Control, Microbiology, Sterilization, Contract Manufacturing, Quality Auditing, FDA, Part 820, 21 CFR, Controlled Environments, Environmental Monitoring, Design Control, Laboratory, Change Control, Pharmaceutical Industry, Validation, Clean Rooms, Aseptic Processing, Manufacturing, Sop, SOP
Education
Southern Illinois University, Carbondale 1995 — 1998
BA, Microbiology
Harper College 1993 — 1995
Associates Degree, Science
Sascha Hedjbeli Sascha Hedjbeli's Pharmaceutical Systems Inc Experience 2000 - 2004
Job Purchasing Manager at Rosalind Franklin University
Industry Higher Education
Experience
Rosalind Franklin University February 2015 - Present
Rosalind Franklin University of Medicine and Science 2004 - Present
Pharmaceutical Systems, Inc. 2000 - 2004
Northwestern University July 1995 - October 2000
Loyola University Chicago August 1992 - January 1995
Skills
Microsoft Office, Project Management, Customer Service, Process Improvement, Research, Budgets, Strategic Planning, PowerPoint, Leadership, Public Speaking, Purchasing, Team Building, Microsoft Excel, Training, Microsoft Word, Management, Change Management, Negotiation, Healthcare, Project Planning, Teamwork, Event Planning, Program Management, Organizational...
Education
Loyola University Chicago 1988 — 1995
Von Steuben MSC
Rosalind Franklin University February 2015 - Present
Rosalind Franklin University of Medicine and Science 2004 - Present
Pharmaceutical Systems, Inc. 2000 - 2004
Northwestern University July 1995 - October 2000
Loyola University Chicago August 1992 - January 1995
Skills
Microsoft Office, Project Management, Customer Service, Process Improvement, Research, Budgets, Strategic Planning, PowerPoint, Leadership, Public Speaking, Purchasing, Team Building, Microsoft Excel, Training, Microsoft Word, Management, Change Management, Negotiation, Healthcare, Project Planning, Teamwork, Event Planning, Program Management, Organizational...
Education
Loyola University Chicago 1988 — 1995
Von Steuben MSC
Seth Rindner's Pharmaceutical Systems Inc Experience August 2005 - September 2005
Job Associate QA Manager at Topco Associates LLC
Industry Biotechnology
Experience
Topco Associates LLC July 2015 - Present
Topco Associates LLC July 2015 - Present
Vetter Development Services February 2015 - July 2015
Dow Microbial Control August 2006 - September 2014
Pharmaceutical Systems, Inc. August 2005 - September 2005
Pharmaceutical Systems, Inc. February 2004 - August 2005
Skills
PCR, Molecular Biology, ELISA, Cell Culture, Microbiology, Biotechnology, Western Blotting, GLP, R&D, Lifesciences, Industrial Hygiene, Chemistry, Microsoft Excel, Microsoft Word, Customer Service, Product Development, Laboratory, Life Sciences, Validation
Education
Roosevelt University 2003 — 2004
Master of Science (M.S.), Biotechnology, 3.5
Elmhurst College 1999 — 2002
Bachelor of Science (B.S.), Biology, General
Topco Associates LLC July 2015 - Present
Topco Associates LLC July 2015 - Present
Vetter Development Services February 2015 - July 2015
Dow Microbial Control August 2006 - September 2014
Pharmaceutical Systems, Inc. August 2005 - September 2005
Pharmaceutical Systems, Inc. February 2004 - August 2005
Skills
PCR, Molecular Biology, ELISA, Cell Culture, Microbiology, Biotechnology, Western Blotting, GLP, R&D, Lifesciences, Industrial Hygiene, Chemistry, Microsoft Excel, Microsoft Word, Customer Service, Product Development, Laboratory, Life Sciences, Validation
Education
Roosevelt University 2003 — 2004
Master of Science (M.S.), Biotechnology, 3.5
Elmhurst College 1999 — 2002
Bachelor of Science (B.S.), Biology, General
Jason Robelia Jason Robelia's Pharmaceutical Systems Inc Experience October 2002 - May 2006
Job Sr Analyst, HR Operations at Baxalta
Industry Information Technology and Services
SEAN ZIEGLER SEAN ZIEGLER's Pharmaceutical Systems Inc Experience June 1999 - December 1999
Job Institutional Salesperson at FC Ziegler Company
Industry Consumer Goods
Experience
FC Ziegler Company January 2011 - Present
FC Ziegler Company November 2006 - December 2010
Zachary Scott Theatre 2010 - 2010
US Army July 2000 - July 2006
Abbott Laboratories January 2000 - July 2000
Pharmaceutical Systems, INC June 1999 - December 1999
Skills
Management, Music, Sales, Fitness Training, Leadership, Training, Public Speaking, Marketing, Event Management
Education
The University of Texas at Austin 2007 — 2007
Austin Community College 2006 — 2007
Web Page Design, music
Central Texas College 2002 — 2004
Music
University of Notre Dame 1995 — 1999
BS, Biology
FC Ziegler Company January 2011 - Present
FC Ziegler Company November 2006 - December 2010
Zachary Scott Theatre 2010 - 2010
US Army July 2000 - July 2006
Abbott Laboratories January 2000 - July 2000
Pharmaceutical Systems, INC June 1999 - December 1999
Skills
Management, Music, Sales, Fitness Training, Leadership, Training, Public Speaking, Marketing, Event Management
Education
The University of Texas at Austin 2007 — 2007
Austin Community College 2006 — 2007
Web Page Design, music
Central Texas College 2002 — 2004
Music
University of Notre Dame 1995 — 1999
BS, Biology
Robert Reich Robert Reich's Pharmaceutical Systems Inc Experience 1991 - 2006
Job President at LexaMed, Ltd.
Industry Medical Devices
Experience
LexaMed, Ltd. 2006 - Present
Pharmaceutical Systems, Inc. 1991 - 2006
Ethox Corp 1981 - 1991
Getinge (formerly Castle Company) 1976 - 1981
Pfizer 1973 - 1976
Skills
CAPA, Medical Devices, ISO 13485, Validation, FDA, GMP, GLP, Sop, Microbiology, Pharmaceutical Industry, Quality System, V&V, Change Control, Aseptic Processing, Regulatory Affairs, Sterilization, Quality Assurance, Quality Auditing, R&D, Design Control, Environmental Monitoring, Quality Control, ISO, 21 CFR Part 11, Laboratory, Aseptic Technique, Regulatory Submissions, Biotechnology, Biopharmaceuticals, Lifesciences, HPLC, Technology Transfer, Regulatory Requirements, Analytical Chemistry, Commercialization, Life Sciences, SOP
Education
University of Wisconsin-Madison 1969 — 1972
M.S., Microbiology
Indiana State University 1974 — 1975
Doctorate Program, Microbiology
Rutgers, The State University of New Jersey-New Brunswick 1965 — 1969
B.S., Microbiology
LexaMed, Ltd. 2006 - Present
Pharmaceutical Systems, Inc. 1991 - 2006
Ethox Corp 1981 - 1991
Getinge (formerly Castle Company) 1976 - 1981
Pfizer 1973 - 1976
Skills
CAPA, Medical Devices, ISO 13485, Validation, FDA, GMP, GLP, Sop, Microbiology, Pharmaceutical Industry, Quality System, V&V, Change Control, Aseptic Processing, Regulatory Affairs, Sterilization, Quality Assurance, Quality Auditing, R&D, Design Control, Environmental Monitoring, Quality Control, ISO, 21 CFR Part 11, Laboratory, Aseptic Technique, Regulatory Submissions, Biotechnology, Biopharmaceuticals, Lifesciences, HPLC, Technology Transfer, Regulatory Requirements, Analytical Chemistry, Commercialization, Life Sciences, SOP
Education
University of Wisconsin-Madison 1969 — 1972
M.S., Microbiology
Indiana State University 1974 — 1975
Doctorate Program, Microbiology
Rutgers, The State University of New Jersey-New Brunswick 1965 — 1969
B.S., Microbiology
Cecil Grymkoski's Pharmaceutical Systems Inc Experience 1999 - 2004
Job PRODUCTION
Industry Mining & Metals
Experience
Gcc Rio Grande June 2007 - Present
Amgen 2004 - 2006
PHARMACEUTICAL SYSTEMS INC 1999 - 2004
Abbott Laboratories 1996 - 1998
Enterprise Systems 1982 - 1990
Education
College of Lake County
Gcc Rio Grande June 2007 - Present
Amgen 2004 - 2006
PHARMACEUTICAL SYSTEMS INC 1999 - 2004
Abbott Laboratories 1996 - 1998
Enterprise Systems 1982 - 1990
Education
College of Lake County
Thomas Cullen Thomas Cullen's Pharmaceutical Systems Inc Experience October 1999 - August 2003
Job Section Manager, Analytical R&D at AbbVie, Inc.
Industry Pharmaceuticals
Experience
AbbVie April 2013 - Present
AbbVie January 2013 - April 2013
Abbott Laboratories May 2007 - December 2012
Ferro Pfanstiehl Laboratories August 2003 - May 2007
Pharmaceutical Systems Inc October 1999 - August 2003
Michigan State University September 1994 - May 1999
Skills
Analytical Chemistry, Validation, cGMP, Pharmaceuticals, LC-MS, HPLC, Chromatography, Problem Solving, GMP, R&D, Cleaning Validation, Technical Writing, Team Leadership, UV-Vis, USP, Methods Development, Raw Materials, Quality Assurance, Chemometrics, IND, Mass Spectrometry, SOP, FDA, 21 CFR Part 11, Gas Chromatography, Chemistry, Dissolution, Wet Chemistry, UV, CAPA, Analytical Techniques, LIMS, Chemstation, Titration, Pharmaceutical..., Formulation Development, Quality Systems, Technology Transfer, Process Validation, UV/Vis, Pharmaceutical Industry, GLP, V&V, FTIR, Sop, Quality System, Quality Control, CMC, Drug Development, Drug Delivery
Education
Michigan State University 1994 — 1999
Ph. D, Chemistry
Illinois Benedictine College (now Benedictine University) 1990 — 1994
B. S, Chemistry
Fenwick High School 1986 — 1990
AbbVie April 2013 - Present
AbbVie January 2013 - April 2013
Abbott Laboratories May 2007 - December 2012
Ferro Pfanstiehl Laboratories August 2003 - May 2007
Pharmaceutical Systems Inc October 1999 - August 2003
Michigan State University September 1994 - May 1999
Skills
Analytical Chemistry, Validation, cGMP, Pharmaceuticals, LC-MS, HPLC, Chromatography, Problem Solving, GMP, R&D, Cleaning Validation, Technical Writing, Team Leadership, UV-Vis, USP, Methods Development, Raw Materials, Quality Assurance, Chemometrics, IND, Mass Spectrometry, SOP, FDA, 21 CFR Part 11, Gas Chromatography, Chemistry, Dissolution, Wet Chemistry, UV, CAPA, Analytical Techniques, LIMS, Chemstation, Titration, Pharmaceutical..., Formulation Development, Quality Systems, Technology Transfer, Process Validation, UV/Vis, Pharmaceutical Industry, GLP, V&V, FTIR, Sop, Quality System, Quality Control, CMC, Drug Development, Drug Delivery
Education
Michigan State University 1994 — 1999
Ph. D, Chemistry
Illinois Benedictine College (now Benedictine University) 1990 — 1994
B. S, Chemistry
Fenwick High School 1986 — 1990
Michele (Strelka) Weir's Pharmaceutical Systems Inc Experience 2002 - 2003
Job Quality Engineer at Nypro
Industry Medical Devices
Experience
Nypro May 2011 - February 2014
Baxter Healthcare September 2006 - May 2010
Morton Grove Pharmaceuticals 2003 - 2004
Pharmaceutical Systems, Inc. 2002 - 2003
Bioport 2002 - 2003
Alpharma 2002 - 2002
Purdue Pharmaceuticals 2002 - 2002
Shering Plough 2000 - 2000
Kester Solder 1999 - 1999
Unichema 1997 - 1997
Skills
Six Sigma, Statistics, CAPA, V&V, Validation, FDA, Quality System, GMP, Change Control, 21 CFR Part 11, Computer System..., Sop, ISO 13485, Medical Devices, Quality Assurance, Pharmaceutical Industry, Design Control, Root Cause Analysis, Minitab, FMEA, Injection Molding, Quality Control, Aseptic Processing, ISO, Contract Manufacturing, FDA GMP, Plastics, Gage R, DMAIC, Molding, CQE, Continuous Improvement, Process Improvement, Conflict Resolution, SOP
Education
Purdue University 1996 — 2001
Bachelor of Science (B.S.), Mechanical Engineering
Conant
Nypro May 2011 - February 2014
Baxter Healthcare September 2006 - May 2010
Morton Grove Pharmaceuticals 2003 - 2004
Pharmaceutical Systems, Inc. 2002 - 2003
Bioport 2002 - 2003
Alpharma 2002 - 2002
Purdue Pharmaceuticals 2002 - 2002
Shering Plough 2000 - 2000
Kester Solder 1999 - 1999
Unichema 1997 - 1997
Skills
Six Sigma, Statistics, CAPA, V&V, Validation, FDA, Quality System, GMP, Change Control, 21 CFR Part 11, Computer System..., Sop, ISO 13485, Medical Devices, Quality Assurance, Pharmaceutical Industry, Design Control, Root Cause Analysis, Minitab, FMEA, Injection Molding, Quality Control, Aseptic Processing, ISO, Contract Manufacturing, FDA GMP, Plastics, Gage R, DMAIC, Molding, CQE, Continuous Improvement, Process Improvement, Conflict Resolution, SOP
Education
Purdue University 1996 — 2001
Bachelor of Science (B.S.), Mechanical Engineering
Conant
Sandy Rubio's Pharmaceutical Systems Inc Experience 1995 - 2001
Job Sr. Sterility Assurance Assoc. at Fresenius Kabi
Industry Pharmaceuticals
Experience
Fresenius Kabi October 2013 - Present
MicroWorks, Inc. October 2005 - October 2013
Pharmaceutical Systems, Inc. 1995 - 2001
Fujisawa USA, Inc. 1991 - 1995
Silliker Laboratories 1989 - 1991
Education
Northern Illinois University 1985 — 1988
B.S.
Fresenius Kabi October 2013 - Present
MicroWorks, Inc. October 2005 - October 2013
Pharmaceutical Systems, Inc. 1995 - 2001
Fujisawa USA, Inc. 1991 - 1995
Silliker Laboratories 1989 - 1991
Education
Northern Illinois University 1985 — 1988
B.S.
Dirk Wieringa Dirk Wieringa's Pharmaceutical Systems Inc Experience February 2003 - March 2006
Job Manager MQA at Fresenius Kabi USA
Industry Pharmaceuticals
Experience
Fresenius Kabi September 2011 - Present
LexaMed July 2006 - September 2011
Pharmaceutical Systems Inc. February 2003 - March 2006
Avatar Corporation January 1998 - February 2003
Rhodia 1980 - 1998
Skills
GMP, FDA, Validation, Sop, CAPA, Change Control, Quality Assurance, Aseptic Processing, LIMS, Medical Devices, Pharmaceutics, 21 CFR Part 11, GLP, Manufacturing, Quality System, V&V, Pharmaceutical Industry, Regulatory Affairs, Quality Control, Testing, ISO 13485
Education
Governors State University 1992 — 1995
BS Analytical Chemistry, Chemistry
Bloom Township 1974 — 1977
Diploma
Fresenius Kabi September 2011 - Present
LexaMed July 2006 - September 2011
Pharmaceutical Systems Inc. February 2003 - March 2006
Avatar Corporation January 1998 - February 2003
Rhodia 1980 - 1998
Skills
GMP, FDA, Validation, Sop, CAPA, Change Control, Quality Assurance, Aseptic Processing, LIMS, Medical Devices, Pharmaceutics, 21 CFR Part 11, GLP, Manufacturing, Quality System, V&V, Pharmaceutical Industry, Regulatory Affairs, Quality Control, Testing, ISO 13485
Education
Governors State University 1992 — 1995
BS Analytical Chemistry, Chemistry
Bloom Township 1974 — 1977
Diploma
Hank Hicks Hank Hicks's Pharmaceutical Systems Inc Experience 2001 - 2005
Job CEO at Quality Process Analysis Consulting, Inc
Industry Pharmaceuticals
Experience
Quality Process Analysis Consulting, Inc August 2015 - Present
Hank Hicks Consulting April 2006 - Present
Natural Alternatives International June 2009 - June 2015
Natural Alternatives International October 2007 - June 2009
ArthroCare Corporation 2006 - 2007
ISTA Pharmaceuticals 2006 - 2006
PSI 2001 - 2006
Pharmaceutical Systems, Inc 2001 - 2005
Emergent BioSolutions 2001 - 2004
Radiance Medical Systems 2000 - 2001
Skills
FDA, ISO 13485, GMP, V&V, Change Control, Sop, Manufacturing, CAPA, Medical Devices, Pharmaceutical Industry, R&D, Regulatory Affairs, Quality Assurance, Quality Control, Process Improvement, GLP, Lean Manufacturing, Design Control, Biotechnology, 21 CFR Part 11, SOP
Education
University of California, Berkeley 1971 — 1977
Quality Process Analysis Consulting, Inc August 2015 - Present
Hank Hicks Consulting April 2006 - Present
Natural Alternatives International June 2009 - June 2015
Natural Alternatives International October 2007 - June 2009
ArthroCare Corporation 2006 - 2007
ISTA Pharmaceuticals 2006 - 2006
PSI 2001 - 2006
Pharmaceutical Systems, Inc 2001 - 2005
Emergent BioSolutions 2001 - 2004
Radiance Medical Systems 2000 - 2001
Skills
FDA, ISO 13485, GMP, V&V, Change Control, Sop, Manufacturing, CAPA, Medical Devices, Pharmaceutical Industry, R&D, Regulatory Affairs, Quality Assurance, Quality Control, Process Improvement, GLP, Lean Manufacturing, Design Control, Biotechnology, 21 CFR Part 11, SOP
Education
University of California, Berkeley 1971 — 1977
James Latham James Latham's Pharmaceutical Systems Inc Experience 1999 - 2006
Job Sr. Consultant at LexaMed
Industry Pharmaceuticals
Experience
LexaMed July 2006 - Present
Care Biopharma 1999 - July 2006
Pharmaceutical Systems, Inc. 1999 - 2006
Skills
Aseptic Processing, CAPA, Environmental Monitoring, Validation, cGMP, Process Validation, Change Control, Cleaning Validation, Pharmaceuticals, ISO 13485, Biopharmaceuticals, SOP, Quality Systems, Biotechnology, Medical Devices, Microbiology, Vaccines, Quality Auditing, Document Management, Compliance, Validations, ISO, Manufacturing, GxP, Technical Writing, Quality Assurance, Quality Management, Auditing, Documentation, QSR, QC, Life Sciences, GMP, 21 CFR Part 11, Deviations, V&V, Quality System, Regulatory Affairs, Computer System..., LIMS, Quality Control, GAMP, Sop, Pharmaceutical Industry, Lifesciences, GLP
Education
East Carolina University 1996 — 1997
Molecular Biology
University of Louisville 1988 — 1993
Bachelors, Biology, Chemistry, History, German
LexaMed July 2006 - Present
Care Biopharma 1999 - July 2006
Pharmaceutical Systems, Inc. 1999 - 2006
Skills
Aseptic Processing, CAPA, Environmental Monitoring, Validation, cGMP, Process Validation, Change Control, Cleaning Validation, Pharmaceuticals, ISO 13485, Biopharmaceuticals, SOP, Quality Systems, Biotechnology, Medical Devices, Microbiology, Vaccines, Quality Auditing, Document Management, Compliance, Validations, ISO, Manufacturing, GxP, Technical Writing, Quality Assurance, Quality Management, Auditing, Documentation, QSR, QC, Life Sciences, GMP, 21 CFR Part 11, Deviations, V&V, Quality System, Regulatory Affairs, Computer System..., LIMS, Quality Control, GAMP, Sop, Pharmaceutical Industry, Lifesciences, GLP
Education
East Carolina University 1996 — 1997
Molecular Biology
University of Louisville 1988 — 1993
Bachelors, Biology, Chemistry, History, German
James Donnell James Donnell's Pharmaceutical Systems Inc Experience June 2004 - June 2006
Job COO, QC Microvigilant: Specialist in QC Microbiology for Consumer Pharmaceuticals / Medical Devices, Certified, NRM 2004
Industry Pharmaceuticals
Experience
QC Microvigilant, LLC March 2013 - Present
Independent Consultant January 2013 - March 2013
QSC Inc. (Quality Systems and Compliance) August 2011 - December 2012
Kanghong-Sagent Pharmaceutical, Chengdu, P.R. China August 2008 - March 2011
Cardinal Health / Catalent Pharma Solutions July 2006 - December 2007
Pharmaceutical Systems, Inc. June 2004 - June 2006
NeoRx October 2003 - May 2004
Allergan August 2000 - October 2003
Colgate Oral Pharmaceuticals December 1997 - September 2000
On Assignment Lab Support April 1996 - December 1997
Skills
Compliance..., Corrective and..., Validation, Environmental Monitoring, Equipment Qualification, Method Transfer, FDA, Aseptic Processing, GMP, Quality System, Sop, Cleaning Validation, 21 CFR Part 11, Change Control, Pharmaceutical Industry, Technology Transfer, LIMS, Regulatory Affairs, CAPA, Analytical Chemistry, Quality Assurance, Microbiology, Biopharmaceuticals, Biotechnology, Quality Control, Quality Auditing, Lifesciences, Deviations, USP, FDA GMP, Trackwise, Pharmaceutics, Aseptic Technique, Laboratory, Endotoxin, Sterility Assurance, HPLC, Analytical Method..., Regulatory Requirements, Deviation Management, Pharmaceutical..., GAMP, cGMP practices, Chromatography, Sterilization, V&V, Medical Devices, Life Sciences, cGMP manufacturing, SOP
Education
The University of Texas at Arlington 1988 — 1995
Bachelors, Microbiology
Kansas Wesleyan University
Santo ISD
QC Microvigilant, LLC March 2013 - Present
Independent Consultant January 2013 - March 2013
QSC Inc. (Quality Systems and Compliance) August 2011 - December 2012
Kanghong-Sagent Pharmaceutical, Chengdu, P.R. China August 2008 - March 2011
Cardinal Health / Catalent Pharma Solutions July 2006 - December 2007
Pharmaceutical Systems, Inc. June 2004 - June 2006
NeoRx October 2003 - May 2004
Allergan August 2000 - October 2003
Colgate Oral Pharmaceuticals December 1997 - September 2000
On Assignment Lab Support April 1996 - December 1997
Skills
Compliance..., Corrective and..., Validation, Environmental Monitoring, Equipment Qualification, Method Transfer, FDA, Aseptic Processing, GMP, Quality System, Sop, Cleaning Validation, 21 CFR Part 11, Change Control, Pharmaceutical Industry, Technology Transfer, LIMS, Regulatory Affairs, CAPA, Analytical Chemistry, Quality Assurance, Microbiology, Biopharmaceuticals, Biotechnology, Quality Control, Quality Auditing, Lifesciences, Deviations, USP, FDA GMP, Trackwise, Pharmaceutics, Aseptic Technique, Laboratory, Endotoxin, Sterility Assurance, HPLC, Analytical Method..., Regulatory Requirements, Deviation Management, Pharmaceutical..., GAMP, cGMP practices, Chromatography, Sterilization, V&V, Medical Devices, Life Sciences, cGMP manufacturing, SOP
Education
The University of Texas at Arlington 1988 — 1995
Bachelors, Microbiology
Kansas Wesleyan University
Santo ISD
Michael J. Miller, Ph.D. Michael J. Miller, Ph.D.'s Pharmaceutical Systems Inc Experience February 2002 - September 2003
Job Pharmaceutical microbiology and rapid microbiology method consultant; microbiology expert witness.
Industry Pharmaceuticals
Experience
rapidmicromethods.com June 2010 - Present
Microbiology Consultants, LLC February 2009 - Present
Eli Lilly October 2003 - February 2009
Pharmaceutical Systems, Inc. February 2002 - September 2003
Bausch & Lomb October 2000 - January 2002
Bausch & Lomb January 1997 - September 2000
Bausch & Lomb March 1994 - December 1996
Bausch & Lomb August 1991 - February 1994
Johnson & Johnson July 1988 - July 1991
Skills
FDA, GMP, Validation, Biotechnology, Microbiology, Technology Transfer, Pharmaceutical Industry, Regulatory Affairs, Biopharmaceuticals, Aseptic Processing, Quality System, V&V, Laboratory, Medical Devices, Pharmaceutics, GLP, Quality Control, Clinical Trials, Regulatory Submissions, Quality Assurance, Biochemistry, ISO 13485, Clinical Development, ISO, Sop, Consulting, Lifesciences, Regulatory Requirements, R&D, Chemistry, Commercialization, Immunology, CAPA, Sterilization, 21 CFR Part 11, Analytical Chemistry, Quality Auditing, Science, Drug Delivery, Aseptic Technique, Chromatography, HPLC, Vaccines, Drug Development, Drug Discovery, Infectious Diseases, Oncology, Change Control, GxP, Hardware Diagnostics
Education
Georgia State University 1983 — 1988
Ph.D., Microbiology and Biochemistry
Hobart and William Smith Colleges 1979 — 1983
B.A., Sociology, Anthropology, Chemistry, Microbiology
Levittown MacArthur
Levittown MacArthur
rapidmicromethods.com June 2010 - Present
Microbiology Consultants, LLC February 2009 - Present
Eli Lilly October 2003 - February 2009
Pharmaceutical Systems, Inc. February 2002 - September 2003
Bausch & Lomb October 2000 - January 2002
Bausch & Lomb January 1997 - September 2000
Bausch & Lomb March 1994 - December 1996
Bausch & Lomb August 1991 - February 1994
Johnson & Johnson July 1988 - July 1991
Skills
FDA, GMP, Validation, Biotechnology, Microbiology, Technology Transfer, Pharmaceutical Industry, Regulatory Affairs, Biopharmaceuticals, Aseptic Processing, Quality System, V&V, Laboratory, Medical Devices, Pharmaceutics, GLP, Quality Control, Clinical Trials, Regulatory Submissions, Quality Assurance, Biochemistry, ISO 13485, Clinical Development, ISO, Sop, Consulting, Lifesciences, Regulatory Requirements, R&D, Chemistry, Commercialization, Immunology, CAPA, Sterilization, 21 CFR Part 11, Analytical Chemistry, Quality Auditing, Science, Drug Delivery, Aseptic Technique, Chromatography, HPLC, Vaccines, Drug Development, Drug Discovery, Infectious Diseases, Oncology, Change Control, GxP, Hardware Diagnostics
Education
Georgia State University 1983 — 1988
Ph.D., Microbiology and Biochemistry
Hobart and William Smith Colleges 1979 — 1983
B.A., Sociology, Anthropology, Chemistry, Microbiology
Levittown MacArthur
Levittown MacArthur
Jenny DuHamel's Pharmaceutical Systems Inc Experience 1999 - 2005
Job Business owner at Furry Up, Let's Go! Pet Care Service
Industry Consumer Services
Experience
Furry Up, Let's Go! Pet Care Service August 2007 - Present
Pharmaceutical Systems, Inc. 1999 - 2005
Skills
Project Management, Social Networking, Social Media, Microsoft Office, New Business Development, Small Business, Training, Leadership, Social Media Marketing
Education
Ball State University 1997 — 1999
Bachelor of Arts (B.A.), Business Administration and Management, General
Harper College 1994 — 1997
Associate’s Degree, Liberal Arts and Sciences/Liberal Studies
Furry Up, Let's Go! Pet Care Service August 2007 - Present
Pharmaceutical Systems, Inc. 1999 - 2005
Skills
Project Management, Social Networking, Social Media, Microsoft Office, New Business Development, Small Business, Training, Leadership, Social Media Marketing
Education
Ball State University 1997 — 1999
Bachelor of Arts (B.A.), Business Administration and Management, General
Harper College 1994 — 1997
Associate’s Degree, Liberal Arts and Sciences/Liberal Studies
Paul Jurek Paul Jurek's Pharmaceutical Systems Inc Experience 2002 - 2004
Job Director of Quality and Production at Macrocyclics, Inc.
Industry Chemicals
Experience
Macrocyclics, Inc. 2004 - Present
Pharmaceutical Systems, Inc. 2002 - 2004
Superior Graphite 2000 - 2002
Skills
GMP, FDA, Sop, Chemistry, Analytical Chemistry, Product Development, R&D, Validation, Quality System, HPLC
Education
Texas A&M University 1995 — 1999
Ph.D., Chemistry
Jamestown College 1991 — 1995
B.A., Chemistry
Macrocyclics, Inc. 2004 - Present
Pharmaceutical Systems, Inc. 2002 - 2004
Superior Graphite 2000 - 2002
Skills
GMP, FDA, Sop, Chemistry, Analytical Chemistry, Product Development, R&D, Validation, Quality System, HPLC
Education
Texas A&M University 1995 — 1999
Ph.D., Chemistry
Jamestown College 1991 — 1995
B.A., Chemistry
Al DeLosSantos's Pharmaceutical Systems Inc Experience January 2003 - August 2003
Job Senior Consultant at Northern Trust Corporation
Industry Information Technology and Services
Experience
Northern Trust Corporation November 2013 - Present
Atlantic Power Corporation September 2012 - July 2013
Bank of Montreal August 2007 - March 2012
Rosenthal Collins Group September 2004 - May 2007
Independent September 2003 - August 2004
Pharmaceutical Systems Inc. January 2003 - August 2003
Independent March 2001 - December 2002
Cimlinc Inc. April 1999 - February 2001
International Urban Associates April 1997 - September 1998
SPSS Inc. August 1996 - March 1997
Skills
Business Analysis, Financial Analysis, Project Management, SDLC, Fixed Income, Derivatives, Data Analysis, Process Improvement
Education
Northwestern University - Kellogg School of Management 1995 — 1998
MBA, Finance, Accounting, Marketing
Texas A&M University 1983 — 1988
BS, Mechanical Engineering
Northern Trust Corporation November 2013 - Present
Atlantic Power Corporation September 2012 - July 2013
Bank of Montreal August 2007 - March 2012
Rosenthal Collins Group September 2004 - May 2007
Independent September 2003 - August 2004
Pharmaceutical Systems Inc. January 2003 - August 2003
Independent March 2001 - December 2002
Cimlinc Inc. April 1999 - February 2001
International Urban Associates April 1997 - September 1998
SPSS Inc. August 1996 - March 1997
Skills
Business Analysis, Financial Analysis, Project Management, SDLC, Fixed Income, Derivatives, Data Analysis, Process Improvement
Education
Northwestern University - Kellogg School of Management 1995 — 1998
MBA, Finance, Accounting, Marketing
Texas A&M University 1983 — 1988
BS, Mechanical Engineering
Susan DeBrocke, PMP's Pharmaceutical Systems Inc Experience January 2002 - August 2002
Job IT Program Manager at UnitedHealthcare Community & State
Industry Information Technology and Services
Experience
UnitedHealthcare Community & State October 2009 - Present
US Airways January 2008 - August 2009
Comsys December 2006 - August 2009
US Airways July 2007 - January 2008
US Airways December 2006 - June 2007
DHL 2004 - 2006
Synectics April 2003 - July 2004
Pharmaceutical Systems Inc January 2002 - August 2002
Material Sciences Corporation February 1999 - December 2001
Material Sciences Corporation 1998 - 1999
Skills
Validation, Organization, High Performance Teams, Customer Requirements, Program Management, Process Improvement, SDLC, Business Analysis, Vendor Management, PMP, PMO, Project Management, PMBOK, Solution Architecture, IT Service Management, Requirements Analysis, SharePoint, MS Project, Integration, Cross-functional Team..., Management, Leadership, IT Management, Change Management, Software Documentation, Team Leadership, Visio, Agile Methodologies, Testing, Product Development, Business Process..., Software Project..., Strategy, Project Portfolio..., IT Strategy, ERP, Business Process, Databases, Requirements Gathering, Business Intelligence, Enterprise Software, Resource Management, Governance
Education
Keller Graduate School of Management of DeVry University 1997 — 2001
MBA
Valparaiso University 1978 — 1982
BS
Arlington High School 1974 — 1978
UnitedHealthcare Community & State October 2009 - Present
US Airways January 2008 - August 2009
Comsys December 2006 - August 2009
US Airways July 2007 - January 2008
US Airways December 2006 - June 2007
DHL 2004 - 2006
Synectics April 2003 - July 2004
Pharmaceutical Systems Inc January 2002 - August 2002
Material Sciences Corporation February 1999 - December 2001
Material Sciences Corporation 1998 - 1999
Skills
Validation, Organization, High Performance Teams, Customer Requirements, Program Management, Process Improvement, SDLC, Business Analysis, Vendor Management, PMP, PMO, Project Management, PMBOK, Solution Architecture, IT Service Management, Requirements Analysis, SharePoint, MS Project, Integration, Cross-functional Team..., Management, Leadership, IT Management, Change Management, Software Documentation, Team Leadership, Visio, Agile Methodologies, Testing, Product Development, Business Process..., Software Project..., Strategy, Project Portfolio..., IT Strategy, ERP, Business Process, Databases, Requirements Gathering, Business Intelligence, Enterprise Software, Resource Management, Governance
Education
Keller Graduate School of Management of DeVry University 1997 — 2001
MBA
Valparaiso University 1978 — 1982
BS
Arlington High School 1974 — 1978
Anne Huffman's Pharmaceutical Systems Inc Experience 1998 - 2005
Job Senior Director Quality Assurance at Fresenius Kabi USA
Industry Pharmaceuticals
Experience
Fresenius Kabi USA August 2012 - Present
APP Pharmaceuticals December 2007 - Present
Pharmaceutical Systems, Inc. 1998 - 2005
Education
North Carolina State University 1979 — 1983
Biology, General
Fresenius Kabi USA August 2012 - Present
APP Pharmaceuticals December 2007 - Present
Pharmaceutical Systems, Inc. 1998 - 2005
Education
North Carolina State University 1979 — 1983
Biology, General
Jim Kulla's Pharmaceutical Systems Inc Experience November 1999 - May 2006
Job Sr. Vice President at LexaMed
Industry Pharmaceuticals
Experience
LexaMed July 2006 - Present
LexaMed Ltd. July 2006 - 2008
Pharmaceutical Systems, Inc. November 1999 - May 2006
BEC Laboratories, Inc September 1980 - November 1999
NAMSA November 1977 - September 1980
Baxter Laboratories September 1967 - November 1977
Skills
FDA, Validation, CAPA
Education
University of Illinois College of Medicine 1963 — 1967
MS, Microbiology
Purdue University 1959 — 1963
BS, Biology
LexaMed July 2006 - Present
LexaMed Ltd. July 2006 - 2008
Pharmaceutical Systems, Inc. November 1999 - May 2006
BEC Laboratories, Inc September 1980 - November 1999
NAMSA November 1977 - September 1980
Baxter Laboratories September 1967 - November 1977
Skills
FDA, Validation, CAPA
Education
University of Illinois College of Medicine 1963 — 1967
MS, Microbiology
Purdue University 1959 — 1963
BS, Biology
Navin Tiwari's Pharmaceutical Systems Inc Experience March 2003 - June 2004
Job Process Automation Manager at Genzyme
Industry Computer Software
Experience
Genzyme April 2014 - Present
Genzyme September 2009 - April 2014
Cascade Solutions June 2004 - September 2009
Pharmaceutical Systems, Inc. March 2003 - June 2004
Skills
Automation, Biotechnology, CAPA, GMP, Validation, Process Engineering, Medical Devices, FDA, Process Simulation, Quality System
Education
University of Illinois at Urbana-Champaign
Genzyme April 2014 - Present
Genzyme September 2009 - April 2014
Cascade Solutions June 2004 - September 2009
Pharmaceutical Systems, Inc. March 2003 - June 2004
Skills
Automation, Biotechnology, CAPA, GMP, Validation, Process Engineering, Medical Devices, FDA, Process Simulation, Quality System
Education
University of Illinois at Urbana-Champaign
James Madden's Pharmaceutical Systems Inc Experience 2002 - 2004
Job Quality Manager in Medical Device Manufacturing Industry
Industry Medical Devices
Experience
Lake Region Medical December 2013 - Present
Accellent July 2013 - December 2013
Accellent February 2012 - July 2013
Accellent August 2010 - March 2012
Accellent August 2008 - August 2010
ConMED March 2008 - August 2008
Reglera 2007 - 2007
Boston Scientific 2007 - 2007
bioMerieux 2004 - 2007
Pharmaceutical Systems Inc 2002 - 2004
Skills
Validation, Medical Devices, ISO 13485, CAPA, SPC, Lean Manufacturing, Manufacturing, FMEA, Product Development, Quality Management, Process Validation, Root Cause Analysis, Quality Assurance, Risk Analysis, FDA, Quality Engineering, Quality Auditing, MS Project, Project Planning, International Project..., Engineering, ISO, Manufacturing..., Minitab, Supplier Quality, PPAP, QSR, Process Improvement, Problem Solving, Regulatory Affairs, Calibration, Statistics, cGMP, Process Engineering, Compliance, Inspection, Program Management, Strategic Planning, Quality System, Cross-functional Team..., Supplier Quality..., Gage R&R, Sop, V&V, GMP, Software Documentation, Quality Control, Design of Experiments, ISO 14971, Value Stream Mapping
Education
University of Illinois at Urbana-Champaign 1998 — 2002
Bachelor of Science, Mechanical Engineering
Lake Region Medical December 2013 - Present
Accellent July 2013 - December 2013
Accellent February 2012 - July 2013
Accellent August 2010 - March 2012
Accellent August 2008 - August 2010
ConMED March 2008 - August 2008
Reglera 2007 - 2007
Boston Scientific 2007 - 2007
bioMerieux 2004 - 2007
Pharmaceutical Systems Inc 2002 - 2004
Skills
Validation, Medical Devices, ISO 13485, CAPA, SPC, Lean Manufacturing, Manufacturing, FMEA, Product Development, Quality Management, Process Validation, Root Cause Analysis, Quality Assurance, Risk Analysis, FDA, Quality Engineering, Quality Auditing, MS Project, Project Planning, International Project..., Engineering, ISO, Manufacturing..., Minitab, Supplier Quality, PPAP, QSR, Process Improvement, Problem Solving, Regulatory Affairs, Calibration, Statistics, cGMP, Process Engineering, Compliance, Inspection, Program Management, Strategic Planning, Quality System, Cross-functional Team..., Supplier Quality..., Gage R&R, Sop, V&V, GMP, Software Documentation, Quality Control, Design of Experiments, ISO 14971, Value Stream Mapping
Education
University of Illinois at Urbana-Champaign 1998 — 2002
Bachelor of Science, Mechanical Engineering
Courtney Torchia-Roman's Pharmaceutical Systems Inc Experience 2000 - 2005
Job QA Compliance Supervisor at Fresenius Kabi
Industry Pharmaceuticals
Experience
Fresenius Kabi April 2011 - Present
APP Pharmaceuticals April 2005 - March 2011
Pharmaceutical Systems Inc. 2000 - 2005
Skills
Trackwise, Aseptic Processing, FDA, GMP, Sop, Pharmaceutical Industry, Quality System, Quality Auditing, Environmental Monitoring
Education
Purdue University 1998 — 2002
Bachelor of Science (BS), Microbiology, General and Genetics
Adlai E. Stevenson High School 1994 — 1998
Fresenius Kabi April 2011 - Present
APP Pharmaceuticals April 2005 - March 2011
Pharmaceutical Systems Inc. 2000 - 2005
Skills
Trackwise, Aseptic Processing, FDA, GMP, Sop, Pharmaceutical Industry, Quality System, Quality Auditing, Environmental Monitoring
Education
Purdue University 1998 — 2002
Bachelor of Science (BS), Microbiology, General and Genetics
Adlai E. Stevenson High School 1994 — 1998
Ina Goebel's Pharmaceutical Systems Inc Experience May 2004 - May 2006
Job Research Associate III at Baxter International Inc.
Industry Pharmaceuticals
Experience
Baxter International Inc. July 2013 - Present
Catalent Pharma Solutions December 2010 - July 2013
Catalent Pharma Solutions May 2006 - December 2010
Pharmaceutical Systems inc. May 2004 - May 2006
Skills
CAPA, Quality Control, V&V, Validation, GMP, Laboratory, Sop, Change Control, Microbiology, FDA, Quality Assurance, Environmental Monitoring, USP, Deviations, Aseptic Processing, Pharmaceutical Industry, GxP, LIMS, 21 CFR Part 11, Aseptic Technique
Education
Keller Graduate School of Management of DeVry University 2009 — 2012
MBA, Emphasis in Project Management
Northern Illinois University 1999 — 2004
B.S., Biology, Psychology, Chemistry
Baxter International Inc. July 2013 - Present
Catalent Pharma Solutions December 2010 - July 2013
Catalent Pharma Solutions May 2006 - December 2010
Pharmaceutical Systems inc. May 2004 - May 2006
Skills
CAPA, Quality Control, V&V, Validation, GMP, Laboratory, Sop, Change Control, Microbiology, FDA, Quality Assurance, Environmental Monitoring, USP, Deviations, Aseptic Processing, Pharmaceutical Industry, GxP, LIMS, 21 CFR Part 11, Aseptic Technique
Education
Keller Graduate School of Management of DeVry University 2009 — 2012
MBA, Emphasis in Project Management
Northern Illinois University 1999 — 2004
B.S., Biology, Psychology, Chemistry
Amanda Cleveland's Pharmaceutical Systems Inc Experience 2004 - 2005
Job Clinical Research Associate at ICON Clinical Research
Industry Research
Experience
ICON Clinical Research May 2006 - Present
ACGT 2005 - 2006
Pharmaceutical systems, inc 2004 - 2005
Education
North Central College 2003 — 2004
BA, Biology
ICON Clinical Research May 2006 - Present
ACGT 2005 - 2006
Pharmaceutical systems, inc 2004 - 2005
Education
North Central College 2003 — 2004
BA, Biology
Joanna Stasiek's Pharmaceutical Systems Inc Experience 2002 - 2003
Job at
Industry Pharmaceuticals
Experience
APP Pharmaceuticals May 2010 - Present
APP Pharmaceuticals June 2008 - 2010
Pharmaceutical Systems, Inc. 2002 - 2003
Education
University of Illinois at Urbana-Champaign 1998 — 2002
BS, Chemistry
APP Pharmaceuticals May 2010 - Present
APP Pharmaceuticals June 2008 - 2010
Pharmaceutical Systems, Inc. 2002 - 2003
Education
University of Illinois at Urbana-Champaign 1998 — 2002
BS, Chemistry
Mary Moriva's Pharmaceutical Systems Inc Experience 1994 - 2006
Job Executive Quality Consultant at Regulatory Compliance Associates, Inc.
Industry Pharmaceuticals
Experience
Regulatory Compliance Associates, Inc. May 2013 - Present
American Renolit Corporation LA July 2009 - Present
Maetrics 2008 - 2009
RCA Consulting 2008 - 2008
Leiner Health Products 2007 - 2007
Pharmaceutical Systems, Inc. 1994 - 2006
Skills
Quality System, Medical Devices, Validation, Manufacturing, V&V, ISO 13485, Change Control, Quality Assurance, FDA, CAPA, Quality Auditing, GMP, Process Improvement, ISO, Continuous Improvement, Six Sigma, Analysis, Sop, Cross-functional Team..., Microsoft Excel
Education
Lake Forest Graduate School of Management
Business
Regulatory Compliance Associates, Inc. May 2013 - Present
American Renolit Corporation LA July 2009 - Present
Maetrics 2008 - 2009
RCA Consulting 2008 - 2008
Leiner Health Products 2007 - 2007
Pharmaceutical Systems, Inc. 1994 - 2006
Skills
Quality System, Medical Devices, Validation, Manufacturing, V&V, ISO 13485, Change Control, Quality Assurance, FDA, CAPA, Quality Auditing, GMP, Process Improvement, ISO, Continuous Improvement, Six Sigma, Analysis, Sop, Cross-functional Team..., Microsoft Excel
Education
Lake Forest Graduate School of Management
Business
Diane Albrewczynski's Pharmaceutical Systems Inc Experience 1999 - 2002
Job QC Operations Supervisor
Industry Biotechnology
Experience
Bristol-Myers Squibb May 2008 - Present
AstraZeneca November 2002 - May 2008
Pharmaceutical Systems Inc. 1999 - 2002
Skills
GMP, Validation, Pharmaceutical Industry, Biotechnology, CAPA, Aseptic Processing, Sop, LIMS, Microbiology, Change Control, GLP, Trackwise, FDA, GxP, 21 CFR Part 11, Regulatory Affairs, V&V, Drug Discovery, Infectious Diseases, SOP, TrackWise, Biopharmaceuticals, Technology Transfer
Education
Boston College - Wallace E. Carroll Graduate School of Management 1986 — 1988
none, MBA
Clemson University 1980 — 1982
MS, Microbiology
University of New Hampshire 1974 — 1977
BA, Zoology
Bristol-Myers Squibb May 2008 - Present
AstraZeneca November 2002 - May 2008
Pharmaceutical Systems Inc. 1999 - 2002
Skills
GMP, Validation, Pharmaceutical Industry, Biotechnology, CAPA, Aseptic Processing, Sop, LIMS, Microbiology, Change Control, GLP, Trackwise, FDA, GxP, 21 CFR Part 11, Regulatory Affairs, V&V, Drug Discovery, Infectious Diseases, SOP, TrackWise, Biopharmaceuticals, Technology Transfer
Education
Boston College - Wallace E. Carroll Graduate School of Management 1986 — 1988
none, MBA
Clemson University 1980 — 1982
MS, Microbiology
University of New Hampshire 1974 — 1977
BA, Zoology
Craig Wollschlager's Pharmaceutical Systems Inc Experience 1999 - 2000
Job Microscopy & Digital Imaging Specialist
Industry Medical Devices
Experience
W. Nuhsbaum, Inc. June 2009 - Present
Leica Microsystems January 2006 - June 2009
bioMerieux 2003 - 2005
Abbott Laboratories 2000 - 2003
Pharmaceutical Systems, Inc. 1999 - 2000
Apotex, Inc. 1998 - 1999
Northview Labs, currently SGS Life Science Services 1997 - 1998
Skills
Medical Devices, Digital Imaging, Capital Equipment, Sales, Product Launch, Lifesciences, Market Development, Manufacturing, Biotechnology, Product Marketing, Product Management, Cross-functional Team..., Product Development, Sales Management, Sales Operations, Pharmaceutical Industry, Medical Imaging, Competitive Analysis, Life Sciences, Marketing, Microscopy, R
Education
Lake Forest Graduate School of Management 2003 — 2005
MBA
University of Wisconsin-Stevens Point 1992 — 1997
BS
W. Nuhsbaum, Inc. June 2009 - Present
Leica Microsystems January 2006 - June 2009
bioMerieux 2003 - 2005
Abbott Laboratories 2000 - 2003
Pharmaceutical Systems, Inc. 1999 - 2000
Apotex, Inc. 1998 - 1999
Northview Labs, currently SGS Life Science Services 1997 - 1998
Skills
Medical Devices, Digital Imaging, Capital Equipment, Sales, Product Launch, Lifesciences, Market Development, Manufacturing, Biotechnology, Product Marketing, Product Management, Cross-functional Team..., Product Development, Sales Management, Sales Operations, Pharmaceutical Industry, Medical Imaging, Competitive Analysis, Life Sciences, Marketing, Microscopy, R
Education
Lake Forest Graduate School of Management 2003 — 2005
MBA
University of Wisconsin-Stevens Point 1992 — 1997
BS
Daniel Barbeau's Pharmaceutical Systems Inc Experience 2002 - 2003
Job Site Quality Manager at CareFusion
Industry Pharmaceuticals
Experience
CareFusion September 2014 - Present
Mallinckrodt Pharmaceuticals April 2011 - August 2014
KV Pharmaceutical May 2006 - April 2011
Morton Grove Pharmaceuticals May 2004 - May 2006
Pharmaceutical Systems Inc 2002 - 2003
Skills
FDA, Validation, GMP, V&V, CAPA, Change Control, 21 CFR Part 11, Computer System..., Quality System, Sop, Pharmaceutical Industry, Technology Transfer, LIMS, Cleaning Validation, GxP, Regulatory Affairs, GAMP, Aseptic Processing, GLP, Quality Auditing, Biopharmaceuticals, Contract Manufacturing, Quality by Design, Process Engineering, Continuous Improvement, Quality Assurance, Biotechnology, Cross-functional Team..., R&D, Regulatory Requirements, Pharmaceutics, ISO 13485, Six Sigma, Trackwise, Process Simulation, Quality Management, Quality Control, FDA GMP, Root Cause Analysis, Supplier Quality, SOP development, Design Control, Vaccines, Consent Decree, Regulatory Submissions, Sterilization, Analytical Chemistry, ISO, HPLC, Medical Devices
Education
University of Illinois at Urbana-Champaign 1998 — 2002
BS, Chemical Engineering
CareFusion September 2014 - Present
Mallinckrodt Pharmaceuticals April 2011 - August 2014
KV Pharmaceutical May 2006 - April 2011
Morton Grove Pharmaceuticals May 2004 - May 2006
Pharmaceutical Systems Inc 2002 - 2003
Skills
FDA, Validation, GMP, V&V, CAPA, Change Control, 21 CFR Part 11, Computer System..., Quality System, Sop, Pharmaceutical Industry, Technology Transfer, LIMS, Cleaning Validation, GxP, Regulatory Affairs, GAMP, Aseptic Processing, GLP, Quality Auditing, Biopharmaceuticals, Contract Manufacturing, Quality by Design, Process Engineering, Continuous Improvement, Quality Assurance, Biotechnology, Cross-functional Team..., R&D, Regulatory Requirements, Pharmaceutics, ISO 13485, Six Sigma, Trackwise, Process Simulation, Quality Management, Quality Control, FDA GMP, Root Cause Analysis, Supplier Quality, SOP development, Design Control, Vaccines, Consent Decree, Regulatory Submissions, Sterilization, Analytical Chemistry, ISO, HPLC, Medical Devices
Education
University of Illinois at Urbana-Champaign 1998 — 2002
BS, Chemical Engineering
Alisa Haller's Pharmaceutical Systems Inc Experience 2000 - 2001
Job Technical Reviewer, Sterilization Products at NAMSA
Industry Pharmaceuticals
Experience
NAMSA September 2009 - Present
West Pharmaceutical Services June 2005 - February 2009
Pharmaceutical Systems, Inc. 2000 - 2001
Cole 2000 - 2000
Education
Miami University
Bachelors, Microbiology
NAMSA September 2009 - Present
West Pharmaceutical Services June 2005 - February 2009
Pharmaceutical Systems, Inc. 2000 - 2001
Cole 2000 - 2000
Education
Miami University
Bachelors, Microbiology
Margaret Przybysz's Pharmaceutical Systems Inc Experience 1997 - 2007
Job Sr. Pub Compliance Manager at AbbVie
Industry Pharmaceuticals
Experience
AbbVie November 2013 - Present
Abbvie (through Select Source International) June 2013 - Present
Hospira (through InVentive Health) May 2013 - June 2013
Fenwal December 2007 - April 2013
Pharmaceutical Systems, Inc 1997 - 2007
SoloPak 1996 - 1997
Skills
Validation, CAPA, FDA, Quality System, Quality Auditing, V&V, Medical Devices, Auditing, Microbiology, Training, GMP, ISO 13485, Sop, Change Control, GLP, Design Control, Aseptic Processing, Quality Control, Software Documentation
Education
Loyola University Chicago 1994 — 1996
M.S Program Biology
DePaul University 1990 — 1993
B.S, Biology
AbbVie November 2013 - Present
Abbvie (through Select Source International) June 2013 - Present
Hospira (through InVentive Health) May 2013 - June 2013
Fenwal December 2007 - April 2013
Pharmaceutical Systems, Inc 1997 - 2007
SoloPak 1996 - 1997
Skills
Validation, CAPA, FDA, Quality System, Quality Auditing, V&V, Medical Devices, Auditing, Microbiology, Training, GMP, ISO 13485, Sop, Change Control, GLP, Design Control, Aseptic Processing, Quality Control, Software Documentation
Education
Loyola University Chicago 1994 — 1996
M.S Program Biology
DePaul University 1990 — 1993
B.S, Biology
Dawn Kelley's Pharmaceutical Systems Inc Experience 2003 - 2005
Job Quality Professional
Industry Health, Wellness and Fitness
Experience
Now Foods May 2015 - Present
Now Foods October 2013 - May 2015
URL Pharma, Inc. July 2009 - April 2013
PharmPro December 2005 - July 2009
PHARMACEUTICAL SYSTEMS, INC 2003 - 2005
Skills
Sop, Biotechnology, Quality Assurance, Quality Auditing, Quality System, Cleaning Validation, 21 CFR Part 11, Trackwise, Batch Records, Documentation Practices, Quality Investigations, CAPAs, GxP, Pharmaceutical..., Particle Size Analysis, Microbiology, Bacteriology, Pharmaceutical..., Purified Water, cGMP practices, FDA GMP, SOP development, SOP authoring, USP, Aseptic Technique, Gram Staining, Bacterial Identification, Serial Dilutions, Pipetting, Centrifuge, pH meter, V&V, Aseptic Processing, Change Control, Quality Control, HPLC, Formulation, SOP
Education
Roosevelt University 1999 — 2003
Bachelor of Professional Studies, Chemical Science
Now Foods May 2015 - Present
Now Foods October 2013 - May 2015
URL Pharma, Inc. July 2009 - April 2013
PharmPro December 2005 - July 2009
PHARMACEUTICAL SYSTEMS, INC 2003 - 2005
Skills
Sop, Biotechnology, Quality Assurance, Quality Auditing, Quality System, Cleaning Validation, 21 CFR Part 11, Trackwise, Batch Records, Documentation Practices, Quality Investigations, CAPAs, GxP, Pharmaceutical..., Particle Size Analysis, Microbiology, Bacteriology, Pharmaceutical..., Purified Water, cGMP practices, FDA GMP, SOP development, SOP authoring, USP, Aseptic Technique, Gram Staining, Bacterial Identification, Serial Dilutions, Pipetting, Centrifuge, pH meter, V&V, Aseptic Processing, Change Control, Quality Control, HPLC, Formulation, SOP
Education
Roosevelt University 1999 — 2003
Bachelor of Professional Studies, Chemical Science
Dr. David Khorzad's Pharmaceutical Systems Inc Experience September 2000 - June 2004
Job Healthcare Lean Six Sigma Master Black Belt
Industry Hospital & Health Care
Experience
Abbott Laboratories June 2009 - Present
Abbott Laboratories January 2008 - June 2009
Abbott Laboratories June 2004 - January 2008
PHARMACEUTICAL SYSTEMS, Inc September 2000 - June 2004
Ingersoll Rand January 1999 - September 2000
LMI Technologies April 1997 - January 1999
University of Michigan 1991 - 1996
Skills
Six Sigma, Program Management, Process Improvement, Product Management, Marketing, Strategy, Business Development, Automotive, Sales, Competitive Analysis, Business Process
Education
Lake Forest Graduate School of Management 2000 — 2003
MBA, International Business
University of Michigan 1992 — 1996
PhD, Mechanical Engineering
University of Michigan 1991 — 1992
MS, Mechanical Engineering
Purdue University 1987 — 1991
BS, Mechanical Engineering
Abbott Laboratories June 2009 - Present
Abbott Laboratories January 2008 - June 2009
Abbott Laboratories June 2004 - January 2008
PHARMACEUTICAL SYSTEMS, Inc September 2000 - June 2004
Ingersoll Rand January 1999 - September 2000
LMI Technologies April 1997 - January 1999
University of Michigan 1991 - 1996
Skills
Six Sigma, Program Management, Process Improvement, Product Management, Marketing, Strategy, Business Development, Automotive, Sales, Competitive Analysis, Business Process
Education
Lake Forest Graduate School of Management 2000 — 2003
MBA, International Business
University of Michigan 1992 — 1996
PhD, Mechanical Engineering
University of Michigan 1991 — 1992
MS, Mechanical Engineering
Purdue University 1987 — 1991
BS, Mechanical Engineering
Shane Smithee's Pharmaceutical Systems Inc Experience May 2004 - February 2005
Job Life Science Account Manager at Malvern Instruments
Industry Biotechnology
Experience
Malvern Instruments March 2015 - Present
TAP Biosystems April 2013 - March 2015
PerkinElmer September 2011 - March 2013
Theratest Laboratories March 2005 - September 2011
Pharmaceutical Systems Inc. May 2004 - February 2005
Skills
Genomics, Molecular Biology, Lifesciences, High Throughput..., Biochemistry, Biotechnology, Medical Diagnostics, Sales, Business Development, Commercialization, Laboratory Automation, Laboratory, Chromatography, DNA sequencing, Immunoassays, Cell Biology, Drug Discovery, ELISA, Proteomics, PCR, FDA, Validation, Medical Devices, R&D, Hardware Diagnostics, Sequencing, Analytical Chemistry, Pharmaceutical Industry, Protein Chemistry, Life Sciences, Biopharmaceuticals, Microbiology, Regulatory Affairs, Technology Transfer, Assay Development, GLP, Cell Culture, qPCR, Oncology, Cell, DNA, Clinical Research, Purification
Education
Colorado Technical University 2008 — 2010
M.B.A., Healthcare Management
Illinois State University 2000 — 2004
Bachelors of Science, Biology
Malvern Instruments March 2015 - Present
TAP Biosystems April 2013 - March 2015
PerkinElmer September 2011 - March 2013
Theratest Laboratories March 2005 - September 2011
Pharmaceutical Systems Inc. May 2004 - February 2005
Skills
Genomics, Molecular Biology, Lifesciences, High Throughput..., Biochemistry, Biotechnology, Medical Diagnostics, Sales, Business Development, Commercialization, Laboratory Automation, Laboratory, Chromatography, DNA sequencing, Immunoassays, Cell Biology, Drug Discovery, ELISA, Proteomics, PCR, FDA, Validation, Medical Devices, R&D, Hardware Diagnostics, Sequencing, Analytical Chemistry, Pharmaceutical Industry, Protein Chemistry, Life Sciences, Biopharmaceuticals, Microbiology, Regulatory Affairs, Technology Transfer, Assay Development, GLP, Cell Culture, qPCR, Oncology, Cell, DNA, Clinical Research, Purification
Education
Colorado Technical University 2008 — 2010
M.B.A., Healthcare Management
Illinois State University 2000 — 2004
Bachelors of Science, Biology
William Fleming Ph.D's Pharmaceutical Systems Inc Experience June 1994 - June 1996
Job President and Chief Consultant at GXP and Microbiology Compliance Consulting, LLC
Industry Pharmaceuticals
Experience
GXP and Microbiology Compliance Consulting, LLC June 2012 - Present
Alkermes, Inc August 2012 - August 2013
MedImmune July 2008 - June 2012
Medimmune/AstraZeneca July 2004 - July 2008
Aventis Behring June 1999 - June 2004
DiChem Concentrate, Inc. (contract Manufacturer of Dialysis Concentrates) January 1996 - June 1999
Pharmaceutical Systems, Inc June 1994 - June 1996
Beckman Instruments June 1994 - June 1996
Elmhurst Memorial Healthcare January 1991 - April 1994
Wadley Institutes of Molecular Medicine June 1975 - December 1990
Skills
Validation, GMP, Aseptic Processing, Microbiology, Sop, FDA, CAPA, Biopharmaceuticals, Biotechnology, Pharmaceutical Industry, GLP, Technology Transfer, Quality System, LIMS, V&V, Regulatory Affairs, Vaccines, Cleaning Validation, Change Control, Lifesciences, GxP, Laboratory, Virology, Quality Assurance, Quality Control, Analytical Chemistry, R&D, Assay Development, Aseptic Technique, ELISA, Immunology, Medical Devices, Sterilization, UV/Vis, Monoclonal Antibodies, Pharmaceutics, Environmental Monitoring, 21 CFR Part 11, Chromatography, Drug Development, Computer System..., Trackwise, Clinical Development, Regulatory Submissions, HPLC, Formulation, SOP, Life Sciences
Education
University of North Texas 1975 — 1983
Doctor of Philosophy (PhD), Microbiology and Immunology
Tulane University 1971 — 1973
Master of Science (MS), Medical Microbiology and Bacteriology
Tulane University 1967 — 1971
Bachelor of Science (BS), Biology, General
St. Marks Scool of Texas
GXP and Microbiology Compliance Consulting, LLC June 2012 - Present
Alkermes, Inc August 2012 - August 2013
MedImmune July 2008 - June 2012
Medimmune/AstraZeneca July 2004 - July 2008
Aventis Behring June 1999 - June 2004
DiChem Concentrate, Inc. (contract Manufacturer of Dialysis Concentrates) January 1996 - June 1999
Pharmaceutical Systems, Inc June 1994 - June 1996
Beckman Instruments June 1994 - June 1996
Elmhurst Memorial Healthcare January 1991 - April 1994
Wadley Institutes of Molecular Medicine June 1975 - December 1990
Skills
Validation, GMP, Aseptic Processing, Microbiology, Sop, FDA, CAPA, Biopharmaceuticals, Biotechnology, Pharmaceutical Industry, GLP, Technology Transfer, Quality System, LIMS, V&V, Regulatory Affairs, Vaccines, Cleaning Validation, Change Control, Lifesciences, GxP, Laboratory, Virology, Quality Assurance, Quality Control, Analytical Chemistry, R&D, Assay Development, Aseptic Technique, ELISA, Immunology, Medical Devices, Sterilization, UV/Vis, Monoclonal Antibodies, Pharmaceutics, Environmental Monitoring, 21 CFR Part 11, Chromatography, Drug Development, Computer System..., Trackwise, Clinical Development, Regulatory Submissions, HPLC, Formulation, SOP, Life Sciences
Education
University of North Texas 1975 — 1983
Doctor of Philosophy (PhD), Microbiology and Immunology
Tulane University 1971 — 1973
Master of Science (MS), Medical Microbiology and Bacteriology
Tulane University 1967 — 1971
Bachelor of Science (BS), Biology, General
St. Marks Scool of Texas
Jonathan Markwald's Pharmaceutical Systems Inc Experience November 2002 - June 2004
Job Product Manager, Dremel Corded Rotary Tools at Robert Bosch Tool Corporation
Industry Mechanical or Industrial Engineering
Experience
Robert Bosch Tool Corporation February 2014 - Present
Robert Bosch Tool Corporation June 2012 - February 2014
Robert Bosch Tool Corporation January 2010 - June 2012
Robert Bosch Tool Corporation December 2007 - December 2009
R.G.RAY Corporation June 2004 - December 2007
Pharmaceutical Systems, Inc. November 2002 - June 2004
Skills
Product Development, Pro/Engineer, CAD, Solidworks, Automotive, GD&T, FMEA, Product Design, Project Management, Mechanical Engineering, Manufacturing Processes
Education
DePaul University - Charles H. Kellstadt Graduate School of Business 2009 — 2013
MBA, New Product Management
University of Illinois at Urbana-Champaign 1998 — 2002
B.S., Mechanical Engineering, Minor: Math
Robert Bosch Tool Corporation February 2014 - Present
Robert Bosch Tool Corporation June 2012 - February 2014
Robert Bosch Tool Corporation January 2010 - June 2012
Robert Bosch Tool Corporation December 2007 - December 2009
R.G.RAY Corporation June 2004 - December 2007
Pharmaceutical Systems, Inc. November 2002 - June 2004
Skills
Product Development, Pro/Engineer, CAD, Solidworks, Automotive, GD&T, FMEA, Product Design, Project Management, Mechanical Engineering, Manufacturing Processes
Education
DePaul University - Charles H. Kellstadt Graduate School of Business 2009 — 2013
MBA, New Product Management
University of Illinois at Urbana-Champaign 1998 — 2002
B.S., Mechanical Engineering, Minor: Math
Nancy Gieske's Pharmaceutical Systems Inc Experience 1990 - 1991
Job Principal at Nancy Gieske Consulting
Industry Biotechnology
Experience
Nancy Gieske Consulting May 2011 - Present
Genentech 2010 - 2011
Genentech 2005 - 2010
Chiron Corporation 1997 - 2005
Matrix Pharmaceuticals 1997 - 1997
Baxter Biotech 1993 - 1997
Life Science International 1991 - 1993
Pharmaceutical Systems Inc. 1990 - 1991
Magnetronics, Inc. 1989 - 1990
Skills
Validation, GMP, FDA, Quality Control, Sop, Quality Assurance, Biopharmaceuticals, Change Control, Quality System, Cleaning Validation, Microbiology, Quality Management, CAPA, SOP, Biotechnology, Pharmaceutical Industry, Purification, Laboratory, V, V&V
Education
University of Minnesota-Twin Cities 1985 — 1988
Master of Science (M.Sc.), Food Science, Pharm. Sterilization
South Dakota State University
Bachelor of Science (B.Sc.), Food Science & Nutrition, chemistry
Nancy Gieske Consulting May 2011 - Present
Genentech 2010 - 2011
Genentech 2005 - 2010
Chiron Corporation 1997 - 2005
Matrix Pharmaceuticals 1997 - 1997
Baxter Biotech 1993 - 1997
Life Science International 1991 - 1993
Pharmaceutical Systems Inc. 1990 - 1991
Magnetronics, Inc. 1989 - 1990
Skills
Validation, GMP, FDA, Quality Control, Sop, Quality Assurance, Biopharmaceuticals, Change Control, Quality System, Cleaning Validation, Microbiology, Quality Management, CAPA, SOP, Biotechnology, Pharmaceutical Industry, Purification, Laboratory, V, V&V
Education
University of Minnesota-Twin Cities 1985 — 1988
Master of Science (M.Sc.), Food Science, Pharm. Sterilization
South Dakota State University
Bachelor of Science (B.Sc.), Food Science & Nutrition, chemistry
Lorna González's Pharmaceutical Systems Inc Experience 2002 - 2004
Job Consultant | Developer and Manager of Pharmaceutical Quality programs for Compliance | Microbiologist | Spanish Tutor
Industry Pharmaceuticals
Experience
Pharmaceutical Companies (Hospira, Baxter, Abbott April 2012 - December 2013
Berg Pharma August 2011 - May 2012
Various Pharmaceutical Companies October 2009 - August 2011
University of Chicago 2004 - 2009
Pharmaceutical Systems Inc. 2002 - 2004
ABBOTT 2000 - 2003
Terumo Cardiovascular Systems 1997 - 2000
DIFCO Laboratories 1986 - 1995
Skills
FDA, CAPA, Medical Devices, Quality Assurance, Pharmaceutical Industry, Biotechnology, GMP, Aseptic Processing, Quality Control, SOP authoring, Technology Transfer, Medical Microbiology, Industrial Microbiology, Sterility, Test Method Validation..., Process Validation, IVD, QSR Systems Development, Cleanroom Validation, Environmental Monitoring, USP Microbiology Methods, Validation, Microbiology, Sop, Lifesciences, Quality System, Laboratory, Clinical Trials, GLP, Drug Development, Biopharmaceuticals, Regulatory Affairs, Immunoassays, Immunology, Clinical Research, Manufacturing, Cell Culture, Quality Management, Culture Media, Change Requests..., Change Control, Biochemistry, 21 CFR Part 11, Molecular Biology, Clinical Laboratory..., CRO, Analytical Chemistry, Pharmaceutics, GCP, SOP
Education
Eastern Michigan University 1994 — 1996
Masters, Cellular and Molecular Biology
Michigan State University 1982 — 1984
2nd Bachelors, Medical Technology
Universidad de Puerto Rico
Bachelors, Biology
Pharmaceutical Companies (Hospira, Baxter, Abbott April 2012 - December 2013
Berg Pharma August 2011 - May 2012
Various Pharmaceutical Companies October 2009 - August 2011
University of Chicago 2004 - 2009
Pharmaceutical Systems Inc. 2002 - 2004
ABBOTT 2000 - 2003
Terumo Cardiovascular Systems 1997 - 2000
DIFCO Laboratories 1986 - 1995
Skills
FDA, CAPA, Medical Devices, Quality Assurance, Pharmaceutical Industry, Biotechnology, GMP, Aseptic Processing, Quality Control, SOP authoring, Technology Transfer, Medical Microbiology, Industrial Microbiology, Sterility, Test Method Validation..., Process Validation, IVD, QSR Systems Development, Cleanroom Validation, Environmental Monitoring, USP Microbiology Methods, Validation, Microbiology, Sop, Lifesciences, Quality System, Laboratory, Clinical Trials, GLP, Drug Development, Biopharmaceuticals, Regulatory Affairs, Immunoassays, Immunology, Clinical Research, Manufacturing, Cell Culture, Quality Management, Culture Media, Change Requests..., Change Control, Biochemistry, 21 CFR Part 11, Molecular Biology, Clinical Laboratory..., CRO, Analytical Chemistry, Pharmaceutics, GCP, SOP
Education
Eastern Michigan University 1994 — 1996
Masters, Cellular and Molecular Biology
Michigan State University 1982 — 1984
2nd Bachelors, Medical Technology
Universidad de Puerto Rico
Bachelors, Biology
Reggie Lualhati's Pharmaceutical Systems Inc Experience May 2002 - February 2004
Job Project Engineer at Concep Machine Company, Inc.
Industry Mechanical or Industrial Engineering
Experience
Concep Machine Company, Inc. April 2014 - Present
Medivation April 2014 - July 2014
ATS sortimat April 2012 - July 2014
ixmation North America May 2008 - April 2012
Concep Machine Company, Inc. February 2004 - May 2008
Pharmaceutical Systems, Inc. May 2002 - February 2004
Skills
Automation, Engineering, Solidworks, Design for Manufacturing, Robotics, Mechanical Engineering, Machining, Manufacturing, Machine Design, AutoCAD, CAD, Lean Manufacturing, Manufacturing..., Machine Vision, Project Engineering, Pneumatics, Quality Assurance, FMEA, Sheet Metal, Validation, Root Cause Analysis, GD, ISO 13485, Quality System, Servo, FDA, Machine Tools, Metal Fabrication, SolidWorks PDM Work..., PFMEA, SolidWorks
Education
University of Illinois at Urbana-Champaign 1998 — 2002
Bachelor of Science, Mechanical Engineering
Concep Machine Company, Inc. April 2014 - Present
Medivation April 2014 - July 2014
ATS sortimat April 2012 - July 2014
ixmation North America May 2008 - April 2012
Concep Machine Company, Inc. February 2004 - May 2008
Pharmaceutical Systems, Inc. May 2002 - February 2004
Skills
Automation, Engineering, Solidworks, Design for Manufacturing, Robotics, Mechanical Engineering, Machining, Manufacturing, Machine Design, AutoCAD, CAD, Lean Manufacturing, Manufacturing..., Machine Vision, Project Engineering, Pneumatics, Quality Assurance, FMEA, Sheet Metal, Validation, Root Cause Analysis, GD, ISO 13485, Quality System, Servo, FDA, Machine Tools, Metal Fabrication, SolidWorks PDM Work..., PFMEA, SolidWorks
Education
University of Illinois at Urbana-Champaign 1998 — 2002
Bachelor of Science, Mechanical Engineering
Danielle West's Pharmaceutical Systems Inc Experience September 2005 - November 2006
Job Sr. Advisor, Specialty Pharmacy and Infusion Proposals at CVS Health
Industry Pharmaceuticals
Experience
CVS Health May 2015 - Present
CVS Health January 2013 - May 2015
CVS Health November 2006 - January 2013
Pharmaceutical Systems, Inc. September 2005 - November 2006
Skills
Pharmacy Benefit..., Managed Care, Proposal Writing, Strategy, Cross-functional Team..., Process Improvement, Pharmaceutical Industry, Software Documentation, Medicare Part D, Pharmacy, Pharmacoeconomics, Data Analysis, Pharmacists, Pharmacy Automation, Medicaid, Diabetes, Specialty Pharmaceutical
Education
Marquette University 2001 — 2005
B.S. in Business Administration, International Business, Marketing, Spanish
Universidad Pontificia Comillas 2004 — 2004
Semester Abroad, International Business, Marketing
CVS Health May 2015 - Present
CVS Health January 2013 - May 2015
CVS Health November 2006 - January 2013
Pharmaceutical Systems, Inc. September 2005 - November 2006
Skills
Pharmacy Benefit..., Managed Care, Proposal Writing, Strategy, Cross-functional Team..., Process Improvement, Pharmaceutical Industry, Software Documentation, Medicare Part D, Pharmacy, Pharmacoeconomics, Data Analysis, Pharmacists, Pharmacy Automation, Medicaid, Diabetes, Specialty Pharmaceutical
Education
Marquette University 2001 — 2005
B.S. in Business Administration, International Business, Marketing, Spanish
Universidad Pontificia Comillas 2004 — 2004
Semester Abroad, International Business, Marketing
Hal Patterson's Pharmaceutical Systems Inc Experience February 2002 - November 2004
Job Vice President, Quality Assurance and CMC
Industry Pharmaceuticals
Experience
ORA January 2013 - Present
ISTA Pharmaceuticals November 2004 - April 2013
Pharmaceutical Systems, Inc February 2002 - November 2004
B Braun Medical - Bological Test Center October 1979 - February 2002
Skills
FDA, CAPA, GMP, Pharmaceutical Industry, Change Control, Sop, Validation, Regulatory Affairs, Medical Devices, GLP, Quality System, Biotechnology
Education
University of California, Irvine 1976 — 1978
Bachelor of Science (BS), Biology, General
University of Washington 1973 — 1974
ORA January 2013 - Present
ISTA Pharmaceuticals November 2004 - April 2013
Pharmaceutical Systems, Inc February 2002 - November 2004
B Braun Medical - Bological Test Center October 1979 - February 2002
Skills
FDA, CAPA, GMP, Pharmaceutical Industry, Change Control, Sop, Validation, Regulatory Affairs, Medical Devices, GLP, Quality System, Biotechnology
Education
University of California, Irvine 1976 — 1978
Bachelor of Science (BS), Biology, General
University of Washington 1973 — 1974
Stephen Wortman's Pharmaceutical Systems Inc Experience August 2004 - May 2006
Job Senior Microbiologist at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions November 2014 - Present
Catalent Pharma Solutions May 2006 - November 2014
Pharmaceutical Systems, Inc. August 2004 - May 2006
Education
Northern Illinois University 2000 — 2004
Bachelor's degree, Biology/Biological Sciences, General
Catalent Pharma Solutions November 2014 - Present
Catalent Pharma Solutions May 2006 - November 2014
Pharmaceutical Systems, Inc. August 2004 - May 2006
Education
Northern Illinois University 2000 — 2004
Bachelor's degree, Biology/Biological Sciences, General