SQA Services, Inc.
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SQA Services, Inc. Employees
US Bureau of Reclamation March 2010 - Present
US Army May 2001 - August 2005
US Army Reserve 2001 - 2005
American Orient Express January 2002 - January 2004
Volt Technical Services May 2001 - July 2001
Quality Assurance NW January 2001 - May 2001
SQA Services, Inc. September 2000 - December 2000
Mar-Tek Industries September 1999 - September 2000
OEA Inc. September 1996 - September 1999
Skills
Engineering, Manufacturing, Quality Assurance, Quality Management, Team Building, Teaching, Marine Engineering, Manufacturing..., Automation, Management, Six Sigma, Continuous Improvement, Systems Engineering, Microsoft Office, Program Management, Customer Service, AutoCAD, Leadership, Microsoft Excel, Project Management, Project Planning, Process Improvement, Strategic Planning, Research, Team Leadership, Testing, Project Engineering, Power Generation, SolidWorks, Engineering Management, Analysis, Mechanical Engineering, CAD, Lean Manufacturing, Inspection, Training, Troubleshooting, Security Clearance, Contract Management, Government
Education
Eastern Washington University 2007 — 2009
Bachelor's degree, Engineerning - Construction Management, 3.4
Spokane Community College 2004 — 2007
Associate's degree, Transfer to EWU, 3.49
Norco Sr High 1983 — 1984
Dodson Jr High School
N/A, Gen ED
Patriot Environmental Laboratory Services, Inc. February 2015 - Present
SQA Services, Inc. August 2010 - November 2014
City of Newport Beach July 2009 - July 2010
Skills
Customer Service, Coordination, Microsoft Office, Microsoft Excel, Microsoft Word, Project Management, Office Administration, Multi Tasking, Geography, Schedules, Process Scheduler, Analysis, Management, Training, Leadership, Quality Assurance
Education
California State University-Long Beach 2007 — 2009
Bachelor of Applied Science (BASc), Environmental Geography
Cypress College 2003 — 2007
Associate's degree, General education
SQA Services, Inc. July 2015 - Present
NTS Unitek March 2015 - Present
Eagle Magnetic - http://www.eaglemagnetic.com/ March 2014 - Present
Verify, Inc. December 2011 - Present
Sacoma International Inc September 2013 - February 2014
Triumph Group (Controls) http://www.triumphgroup.com/companies/triumph-controls-usa January 2001 - November 2011
Lau Industries 1996 - 2001
Pilkington June 1992 - June 1996
Skills
Manufacturing, Engineering, Project Management, Continuous Improvement, Lean Manufacturing, Microsoft Office, Process Improvement, Product Development, Six Sigma, Microsoft Excel, Geometric Dimensioning, Testing, Automotive, Inspection, AS9100, Aerospace, 5S, Sheet Metal, Quality Management, Technical Writing, Manufacturing..., Quality System, Training, Root Cause Analysis, Corrective Actions, Auditing, SPC, Quality Assurance, ISO, Kaizen, FMEA, NDT, Process Engineering, PPAP, Quality Auditing, Quality Control, SAP, Management
Education
University of Phoenix 2012 — 2013
Associate of Science (AS), Information Technology
Olivet Nazarene University 1988 — 1992
Bachelor's Degree, Business Administration and Management, General
SQA Services, Inc. August 2014 - Present
SQA Services, Inc. August 2014 - Present
VaporDNA August 2013 - August 2014
BOOKOFF July 2012 - August 2013
Bath & Body Works August 2010 - March 2011
Skills
Facebook, Public Speaking, Cashiering, Training, Advertising, Communication Skills, Customer Satisfaction, Customer Service, Retail Sales, Microsoft Word, Typing, Twitter, Microsoft PowerPoint, Microsoft Excel, PowerPoint, Social Networking
Education
California State University-Long Beach 2011 — 2012
BA, Communication Studies
SQA Services, Inc. 2013 - Present
Santa Barbara City College 2012 - 2012
Pacific Unitarian Church April 2010 - June 2011
Education
University of California, Santa Barbara 2011 — 2013
B.S., Biological Sciences
United States Air Force Academy 2008 — 2009
SQA Services, Inc. April 2015 - Present
Stryker Sustainability Solutions March 2014 - December 2014
Maetrics, LLC August 2013 - January 2014
Abbott Vascular August 2012 - April 2013
Hospira November 2011 - July 2012
Abbott Diabetes Care January 2011 - October 2011
CACI International Inc June 2008 - June 2009
TAC Worldwide/BAE Systems June 2007 - June 2008
BAE Systems January 2006 - June 2007
Parker Hannifin May 2002 - May 2005
Skills
ISO9001, AS9100, ISO13485, Microsoft Office, Root Cause Analysis, RAB certified QMS..., GD&T, Blueprint reading, ISO 20000, DOE, SPC, TQM, OSHA safety, Environmental Compliance, Kaizen, Lean Manufacturing, ITIL version 3, Quality Assurance, FAR145, JAA/EASA, CAAC, Project management, Iso 9000, Design of Experiments, ISO 13485, FDA, Project Management, V&V, Quality Control, ISO 9000, Quality System, CAPA, Validation
Education
Cleveland State University 1983 — 1988
B.S., Chemical Engineering
Cleveland State University
B.S. Chemical Engineering
Americare Pharmacy May 2012 - Present
SQA Services, Inc. January 2008 - August 2008
Lightower Fiber Networks August 2007 - January 2008
Skills
Customer Service, Microsoft Office, Microsoft Excel, Healthcare, Microsoft Word, PowerPoint, Pharmaceutical Industry, Leadership, Research, Management, Microsoft Project, Outlook, Teamwork, Data Entry, Time Management, Public Speaking, Human Resources
Education
Berkeley College 2013 — 2016
Bachelor's degree, Human Resources Management/Personnel Administration, General
William Paterson University of New Jersey 2006 — 2011
Biology, General
SQA Services, Inc. September 2014 - September 2014
Zistos corporation September 2012 - December 2012
Air Techniques June 2011 - January 2012
Verify July 2010 - June 2011
Swiss Specialties 2002 - May 2009
Smith's aerospace October 1999 - September 2001
Skills
Manufacturing, Machining, Quality Control, Engineering
Education
ASQ 1997 — 1998
Quality programs, quality management, Quality Control Technology/Technician, N/A
Suffolk County Community College 1990 — 1992
N/A, Electrical, Electronics and Communications Engineering, B+
SQA Services, Inc. November 2014 - Present
Skills
SPC, SPC charts, Quality Assurance, Quality Control, Quality System, Microsoft Excel, Microsoft Office, TS16949, Iso 9000, Supplier Quality..., Quality Engineering, New product launch, PPAPs, PFMEA, Control plans, Process Flow Charts, Product Quality, Quality Auditing, JIT, TQM, Lean Manufacturing, Root Cause Analysis, Supplier Quality, Continuous Improvement, Manufacturing, ISO 9000
Education
Macomb Community College 2009 — 2012
Quality Systems Technology, Quality, 3.0
Shell Machine Works, Inc. October 2014 - Present
SQA Services, Inc. September 2014 - October 2014
Quality in Austin April 2014 - October 2014
LTD Material October 2013 - March 2014
Mico Machine Company September 2012 - October 2013
Quality in Austin May 2011 - November 2012
Scientific Machine & Welding March 2011 - April 2011
RSI Inc. September 2006 - August 2010
San Antonio Lighthouse for the Blind June 2004 - September 2006
RG Electronics, Inc. November 2001 - June 2004
Skills
Problem Solving, ISO 9000:2008, AS9100:2009, Business Process..., Procedure Creation, Process Improvement, Procedure Development, Electrical Engineering, Electronics, SMT, Management Consulting, Project Management, Quality Assurance, Quality Management, Supplier Quality, Manufacturing, Lean Manufacturing, Manufacturing..., Contract Manufacturing, Electronics..., Technical Writing, Report Writing, Spreadsheets, Risk Management, Test Management, In-Circuit Test, Word Processing, Linux, Desktop Publishing, Published Author, Instructor-led Training, Hands-on Training, IPC, Soldering, Troubleshooting, Electrical..., Internal Audit, Teaching Adults, Mentoring, Mentoring New Hires, Professional Mentoring, Cross-functional Team..., Team Leadership, Engineering Management, Change Management, Computer Hardware, Windows, CAD, Research, Six Sigma
Education
Iowa Western Community College 1975 — 1976
Electrical and Electronics Engineering
University of Nebraska at Omaha 1975 — 1975
Quality Engineering
Radio Engineering Institute 1972 — 1974
Associate's degree, Electrical and Electronics Engineering
Thomas Jefferson High School, Council Bluffs, IA 1969 — 1971
High School diploma, College Prep
Abstract Electronics Inc February 2015 - Present
SQA Services, Inc. June 2014 - Present
Skills
Quality Assurance, Customer Service, Management, Leadership, Microsoft Office, Microsoft Excel, Teamwork, Team Leadership, Time Management, Inventory Management, Change Management, Windows, Troubleshooting, Call Centers, Training, Budgets, Team Building, Team Management, Sales, Administration, Microsoft Word, PowerPoint, Outlook, Retail, Leadership Development, Purchasing, Hospitality, Event Management, English, Healthcare
Education
Cortiva Institute-Florida 2012 — 2013
St Laszlo tech
Economy
The University of Memphis
Business/Commerce, General
Vasarhelyi Pal tech
Restaurant/Food Services Management
TRF Consulting, LLC January 2012 - Present
SQA Services, Inc. 2012 - Present
Webster University January 2002 - Present
Covidien August 2009 - January 2012
Covidien August 2006 - August 2009
Tyco Healthcare / Mallinckrodt July 2004 - August 2006
Wyeth 2002 - 2004
Skills
GMP, Quality System, CAPA, Quality Assurance, Analytical Chemistry, Root Cause Analysis, FDA, Change Control, Lean Manufacturing, Quality Auditing, Technology Transfer, Quality Management, Quality Control, Process Improvement, Continuous Improvement, Supplier Quality, SPC, Training, FMEA, Aseptic Processing, Analytical Method..., Investigation, Critical Thinking, Parenteral, Equipment Qualification, Pharmaceutical Packaging, Analytical Instruments, Analytical Equipment, Project Management, Laboratory...
Education
University of Kentucky
Certification, Lean Manufacturing
Webster University
Masters Business Administration, 2002
SQA Services, Inc. March 2014 - Present
Clondalkin Group Pharma and Healthcare December 2012 - November 2013
Johnson & Johnson August 2010 - August 2012
St. Jude Medical June 2009 - March 2010
Compass Pharma Services, LLC March 2008 - November 2008
Nosco April 2005 - April 2008
Topflight Corporation April 2002 - April 2005
Skills
Quality System, ISO 13485, CAPA, Quality Auditing, FDA, Quality Management, Change Control, Medical Devices, V&V, GMP, Supplier Quality, Quality Assurance, Root Cause Analysis, Lean Manufacturing, Continuous Improvement, Packaging, Manufacturing, Six Sigma, Quality Control, 5S, Sop, Validation, Kaizen, Iso 9000, Operational Excellence, Cross-functional Team...
Education
International Christian University 1992 — 2000
Doctor of Theology, Theology/Theological Studies
Launch! A Wellness Company. January 2011 - Present
Riviera Sports Physical Therapy June 2002 - Present
The Health Management Academy April 2013 - Present
SQA Services, Inc. December 2008 - August 2010
Pfizer Pharmaceuticals September 1990 - June 2006
Skills
Business Development, Healthcare, Sales, Training, Coaching, Career Counseling, Leadership, Marketing, Start-ups, Pharmaceutical Industry, Managed Care, Leadership Development, Strategic Partnerships, Performance Management, Entrepreneurship, Small Business, Strategy, Cross-functional Team..., Sales Operations, Product Launch, Neurology, Team Building, Team Leadership, Selling, Interviews, Talent Management, Account Management, Time Management, Business Planning
Education
Loyola Marymount University 1986 — 1990
Bachelor of Science, Biology
SQA Services, Inc. 2014 - 2014
SQA Services, Inc. 2014 - 2014
SQA Services, Inc. 2014 - 2014
SQA Services, Inc. 2014 - 2014
Personal Business 2010 - 2011
Medtronic 2004 - 2009
TeligentEMS 2003 - 2003
MTS and EMS in PR 1997 - 2000
Intel 1996 - 1997
Skills
ISO 13485, FMEA, Design of Experiments, Manufacturing, Design for Manufacturing, SPC, DMAIC, Manufacturing..., Root Cause Analysis, Lean Manufacturing
Education
Universidad Politécnica de Puerto Rico
SQA Services, Inc. March 2014 - February 2015
DeVry University March 2012 - December 2013
Inspired by You C.D.C February 2011 - March 2012
Skills
Admissions, Higher Education, Campus, Enrollment Management, Student Affairs, Academic Administration, Higher Education..., Academic Advising, Student Development, Retaining Customers, Adult Education, Student Financial Aid, Student Recruiting, Career Counseling, Critical Thinking, Resume Writing, Career Development, E-Learning, Instructional Design, Microsoft Office, Public Speaking
Education
Keller Graduate School of Management of DeVry University 2014 — 2016
Master of Business Administration (MBA), Health Service Management
DeVry University-Ohio 2011 — 2013
Bachelor of Technical Management (B.T.M.), Health/Health Care Administration/Management, 3.78
Sungear Inc June 2015 - Present
SQA Services, Inc. June 2013 - July 2015
Aviation Equipment Processing April 2014 - May 2015
Jonathan Engineered Solutions May 2006 - June 2013
Thomson Display Mexicana May 2001 - February 2006
Multivisual NEC de Mexico January 1998 - March 2001
Daewoo Orion Mexicana 1996 - 1998
Skills
Task Oriented, Analytics, Product Development, Project Management, Six Sigma, Process Improvement, Cross-functional Team..., FMEA, Lean Manufacturing, Manufacturing, Kaizen, Automotive, Product Management, Engineering, 5S, Program Management, Continuous Improvement, Root Cause Analysis, SPC, Process Engineering, Value Stream Mapping, Lean manufacturing
Education
CETYS Universidad 2008 — 2011
Master Degree, MBA
UABC in Mexicali 1992 — 1996
BS, Electrical Engineer
Don Grimley Consulting October 2009 - Present
NSVSQA January 2009 - July 2011
MasterBrand Cabinets August 2008 - March 2009
Sealy January 2007 - August 2008
NECMSC 2002 - 2005
SQA Services, Inc. 1997 - 2004
SQA Services, Inc. 1997 - 2004
Naval Air Systems Command 1990 - 1997
Skills
Lean Manufacturing, Business Process..., Kaizen, Business Process..., Change Management, six sigma, Theory of Constraints, Kanban, Operational Excellence, Training within Industry, Profound Knowledge, Industry Analysis, Quality Systems..., DMAIC, Quality Management, Process Improvement, Manufacturing, SPC, TQM, Manufacturing Operations, Continuous Improvement, 5S, TPM, Cost Reduction, Toyota Production System, Operations Management, FMEA, Lean Sigma, Cross-functional Team..., ISO, SMED, Quality Assurance, Value Stream Mapping, Manufacturing Management, Root Cause Analysis, Strategic Planning, PDCA, Management Consulting, Lean Initiatives, Business Strategy, Problem Solving, Six Sigma, Manufacturing..., Management, Training, Project Planning, Supply Chain Management, Lean Transformation, Business Process Mapping, Performance Improvement
Education
Kaplan University 2009 — 2011
Business
Oxon Hill High School 1962 — 1965
Kaplan University-Hagerstown Campus
Associate of Arts and Sciences (AAS), Business Administration and Management, General
Saint Leo University
Human Resources
The George Washington University - School of Business
ISO 9000 Lead Auditor
SQA Services, Inc. May 2009 - Present
SQA Services, Inc. December 2008 - May 2009
Wylde Enterprises, LLC July 2008 - January 2009
SQA Services, Inc. November 2007 - November 2008
Skills
Management, Supplier Quality, Supply Chain Management, Quality System, Process Improvement, CAPA, Project Management, New Business Development, Manufacturing, Auditing, FDA, GMP, Supply Chain, Continuous Improvement, Negotiation, Leadership, Supplier Evaluation, Team Leadership, International Business, Management Consulting, Salesforce.com, Strategy, Sales Presentations, International Sales, International Management, International..., Supply Chain Risk..., Pricing Strategy, International Project..., Account Management, Supplier Quality..., Time Management, Development Projects, Customer Management, Presentation Development, Group Presentations, Group Training, Rate Negotiation, Pricing Negotiation, Suppliers Development, Supplier Audits, Supplier Auditing, International Supply...
Education
University of Southern California 2002 — 2006
BS, Public Policy, Planning and Management
Chadwick High School 1998 — 2002
Butech Bliss October 2014 - Present
SQA Services, Inc. September 2014 - October 2014
Kelly Technical/Selas Heat Technology June 2014 - September 2014
Rochling Automotive January 2014 - April 2014
Quality System Architects February 2013 - March 2013
Zimmer Surgical November 2009 - February 2013
The Timken Company June 2007 - June 2009
PTC Alliance September 2000 - April 2006
Skills
Medical Devices, ISO, Word, Quality Systems, FDA, Calibration, Quality System, ISO 13485, Minitab, FDA GMP, Manufacturing, Iso 9000, Gage R, ISO 14971, V&V, Continuous Improvement, Process Improvement, Validation, Root Cause Analysis, CAPA, FMEA, Metrology, Liasoning, Microsoft Word, ISO 9000
Education
ETI Technical College 1988 — 1990
Associate of Applied Science, Electronics, 3.8 GPA
Accenture April 2015 - Present
SHIMADZU CORPORATION 2006 - April 2015
Swissport 2005 - 2006
Castec, Inc. 2003 - 2005
SQA Services, Inc. 2002 - 2003
Accenture 2000 - 2002
Lee Hecht Harrison 1998 - 2000
Skills
Human Resources, Employee Relations, Conflict Resolution, Change Management, Risk Management, Employment Law, Strategic Planning, Process Improvement, Human Resource..., Total Rewards, Employee Benefits, Benefits Administration, Training, Deferred Compensation, Development Of Employees, Organizational..., Payroll, Recruiting, HRIS, Cultural Sensitivity, International..., Workforce Planning, Strategic Policy..., CRM
Education
University of California, Los Angeles 2000 — 2002
Professional Designation in Human Resources Management
University of Washington 1995 — 1997
BA, English
Chapman University 1993 — 1995
ACS Cobham International School, England
SQA Services, Inc. November 2012 - Present
BR Consulting (Canada) July 2010 - Present
Old Dutch Foods March 2014 - October 2014
Wyeth Canada May 2007 - July 2010
Astrazeneca January 2001 - April 2007
Zeneca Pharmaceuticals March 1998 - January 2001
Zeneca Pharmaceuticals 1996 - 1998
Covance 1995 - 1996
Skills
GMP, FDA, Validation, Sop, Regulatory Requirements, Quality Management, CAPA, GxP, 21 CFR Part 11, Computer System..., GLP, Quality Auditing, Internal Audit, FDA GMP, Quality Assurance, GAMP, LIMS, GCP, LC-MS, Quality System, Risk Management, MHRA, Continuous Improvement, SOP development, SOP authoring, Pharmaceutical Industry, Project Management, Risk Assessment, Supplier Evaluation, Change Control, Software Documentation, Auditing, Regulatory Affairs, Management, Biopharmaceuticals, HPLC, Pharmaceutics, ICH Q7, ICH Q9, Supplier Audits, Compliance, Documentation, Health Canada, ASQ Member, Training, Safety, Health and..., HACCP, SQF, SQF practitioner, Food Manufacturing
Education
University of Bradford 1993 — 1996
BSc (Hons), Chemistry with Pharmaceutical and Forensic Science
Coleg Glan Hafren 1991 — 1993
Bishop of Llandaff High School 1985 — 1990
SQA Services, Inc. August 2006 - December 2014
SQA Services March 2002 - August 2006
Applied Materials May 1999 - February 2002
Applied Materials January 1996 - May 1999
Helena Laboratories August 1989 - January 1996
Skills
Inspection, Quality Auditing, Supplier Quality, Validation, Engineering, Cross-functional Team..., Continuous Improvement, Process Engineering, Quality Control, Electronics, Root Cause Analysis, Supply Chain Management, Six Sigma, Materials, Supply Management, Engineering Management, 5S, SPC, GD&T, Automation, Metrology, Microsoft Office, Microsoft Excel, Visio, Teamcenter, PDM, ASME Y14.5, Geometric Dimensioning..., Data Analysis, Pivot Tables, Chart, Flow Charts, Outlook, Oracle, SAP, Training, Vlookup, Conditional Formatting, Macro, Toad
Education
Lamar Institute of Technology 1990 — 1995
Associates, Robotic Technology, 3.0
Airlite Plastics Co October 2007 - Present
SQA Services, Inc. 2009 - 2015
Berry Plastics May 2006 - September 2007
First Data Corporation May 2003 - April 2006
First Data Corporation May 2000 - April 2003
Skyjack Equipment January 1997 - April 2000
Railcar Specialties 1984 - 1996
Railcar Specialties 1984 - 1996
Skills
Quality System, Certified Quality..., Quality Assurance, Root Cause Analysis, RABQSA-Certified Lead..., ISO 9001, ISO 13485, Certified Quality..., 21 CFR 210/211 Medical..., Quality Control, CAPA, Continuous Improvement, Six Sigma, Kaizen, ISO, Manufacturing, Minitab, TQM, Testing, Microsoft Office
Education
University of Nebraska at Omaha
Bachelor of Science (B.S.), Political Science and Government, 3.5
APL Management, Inc. March 2013 - May 2014
SQA Services, Inc. 2010 - 2012
Law Offices of David D. Moriel, APC 2004 - 2005
Skills
Quality Assurance, Internal Audit, Process Improvement, Business Process..., Quality System, Value Stream Mapping, Quality Management, Quality Auditing, ISO, Validation, Six Sigma, Auditing
Education
University of California, Santa Barbara 2007 — 2009
Business Economics with Emphasis in Accoutning
San Pedro High School
SQA Services, Inc. December 2013 - Present
SQA Services, Inc. April 2010 - June 2013
Los Angeles Magazine March 2009 - August 2009
Canyon News February 2009 - March 2009
The Occidental Weekly August 2008 - December 2008
Steez Magazine September 2006 - August 2008
The Occidental Weekly January 2008 - June 2008
Skills
Editing, Social Media, Public Relations, Copy Editing, GMP, Creative Writing, Program Management, Spanish, Storytelling, Editorial, Leadership, Worship, InDesign, Management, Software Documentation, Project Management, Blogging, Coordination, Research, Writing, Facebook, Public Speaking, Journalism, Technical Writing, Proofreading, Time Management, Web Content, PowerPoint, Copywriting, Press Releases, Event Management, Nonprofits, Business Development, Sales
Education
Occidental College 2005 — 2009
Bachelor of Arts (BA), English; Comparative Literary Studies; Journalism
St. Paul's 2002 — 2005
FDA January 2014 - Present
Genzyme February 2012 - January 2014
SQA Services, Inc. July 2011 - January 2014
Teva Pharmaceutical Industries Ltd. September 2010 - June 2011
GlaxoSmithKline October 2009 - July 2010
Stiefel, a GSK company July 2008 - September 2009
Stiefel Laboratories, Inc. July 2007 - June 2008
Stiefel Laboratories, Inc. July 2003 - June 2007
Mindset BioPharmaceuticals 2002 - 2003
NDS Technologies Israel April 2000 - May 2002
Skills
Quality Assurance, GMP, Compliance, Quality Auditing, Knowledge Management, Continuous Improvement, Internal Audit, Quality System, Consent Decree, Biotechnology, Pharmaceutical Industry, GxP, FDA, Management, Biopharmaceuticals, Quality Management, Change Control, Quality Control, 21 CFR Part 11, Software Documentation, Training, ISO 13485, GLP, Computer System..., LIMS, V&V, Regulatory Requirements, Cleaning Validation, Regulatory Submissions, Aseptic Processing, Technology Transfer, Clinical Trials, Trackwise
Education
Albert Einstein College of Medicine of Yeshiva University 1989 — 1992
M.Sc.
Bar-Ilan University 1986 — 1989
B.Sc.
SQA Services, Inc. January 2015 - Present
SQA Services, Inc. February 2007 - January 2015
Little Company of Mary Hospital September 2001 - March 2007
U.S. House of Representatives December 2005 - April 2006
Skills
Supplier Quality, Quality Auditing, Supply Chain Risk..., Quality Assurance, GMP, Temporary Placement, SCRM, Recruiting, Program Management, Regulatory Affairs, Process Improvement, Sourcing, Strategy, Team Leadership, Quality System, Quality Management, Leadership, Auditing, Medical Devices, Continuous Improvement, Human Resources, FDA, Risk Management, Six Sigma, CAPA, Root Cause Analysis, ISO, Training, Sop, Iso 9000, Validation, Talent Acquisition, Technical Recruiting, Manufacturing, Regulatory Requirements, V&V, Biopharmaceuticals, Cross-functional Team..., TQM, Supply Chain, DMAIC, 21 CFR Part 11, Operational Excellence, Business Process..., ISO 13485, Change Control, Pharmaceutical Industry, Kaizen, Change Management
Education
University of California, Santa Barbara 2002 — 2006
BA, Political Science
Kachena Pharma Consultants December 2008 - Present
SQA Services, Inc. 2012 - 2013
Replidyne Inc. April 2005 - June 2008
Ribozyme Pharmaceuticals April 1995 - March 2002
Synergen Inc. January 1993 - August 1994
Berlex Laboratories November 1988 - June 1992
Hoechst-Roussel Pharmaceuticals, Inc. December 1986 - November 1988
Skills
GMP, GLP, FDA, Biotechnology, Pharmaceutical Industry, Regulatory Submissions, R&D, Quality Assurance, Quality Control, Protein Chemistry, Pharmaceutics, Clinical Research, Contract Manufacturing, CMC, Technical Writing, Biopharmaceuticals, Sop, HPLC, Analytical Chemistry, Technology Transfer, Regulatory Affairs, Manufacturing
Education
University of Utah 1981 — 1986
PhD, Chemistry
Montana Tech of the University of Montana 1976 — 1981
Bachelor of Science (BS), Chemistry
Eli Lilly and Company August 2013 - Present
SQA Services, Inc. June 2011 - July 2013
Independent Consulting QA and Logistics June 2010 - May 2011
Piramal June 2009 - April 2010
Sanofi Pasteur October 2006 - October 2008
Wyeth July 2006 - October 2006
Wyeth October 2005 - July 2006
Wyeth June 2004 - October 2005
Wyeth October 2003 - June 2004
Wyeth September 2002 - October 2003
Skills
Troubleshooting, GMP, V&V, FDA, Process Improvement, CAPA, Quality Assurance, Quality System, Formulation, Sop, Root Cause Analysis, Quality Control, Cross-functional Team..., Change Control, Software Documentation, Vaccines, Aseptic Processing, 21 CFR Part 11, Validation, Pharmaceutical Industry, Regulatory Affairs, Medical Devices, ISO 13485, Cleaning Validation, SOP
Education
Lake Forest Graduate School of Management 2000 — 2000
Master of Business Administration (MBA), Business with Healthcare Specialization (Not Completed)
Loyola University of Chicago 1993 — 1997
Bachelor of Science (B.S.), Major: Biology Minor: Chemistry
The Quantic Group January 2011 - Present
Quantic 2011 - 2015
Quantic 2011 - 2015
Consultant 2010 - 2013
SQA Services, Inc. 2000 - 2010
Pfizer Inc. June 1994 - February 2007
Bristol-Myers Squibb Company 1991 - 1994
Wyeth Ayerst International Inc. 1982 - 1991
L. Perrigo Company 1977 - 1982
The Upjohn Company 1967 - 1977
Skills
Quality Assurance, Auditing, ISO, GMP, Food, Manufacturing, Sop, Validation, FDA, Quality Control, CAPA, Iso 9000, Root Cause Analysis, SOP, Testing, Change Control, Leadership, Medical Devices, Pharmaceutical Industry, GxP, Product Development, 21 CFR Part 11, V&V, Quality System, Quality Management, Quality Auditing, Pharmaceutics, Cross-functional Team..., Process Simulation, Six Sigma, Computer System..., Biotechnology, Aseptic Processing, GLP, Regulatory Requirements, LIMS, Laboratory, Regulatory Affairs, R&D, Technology Transfer, Process Improvement, Software Documentation, Continuous Improvement
Education
Michigan State University 1963 — 1967
Bachelor of Science (BS), Chemistry
SQA Services, Inc. November 2010 - July 2012
Skills
Quality Auditing, Quality Management, Continuous Improvement, Quality System, GMP, ISO, Quality Assurance, Supplier Quality, Process Improvement, FDA, Medical Devices, Six Sigma, Root Cause Analysis, Process Simulation, FMEA, DMAIC
Education
California State University-Long Beach 2009 — 2011
MS, Engineering Management
University of Rajasthan 2003 — 2007
B.E., Electronics & Telecommunication
Silanis Technology September 2014 - Present
Silanis Technology May 2014 - August 2014
SQA Services, Inc. September 2013 - April 2014
SQA Services September 2009 - December 2013
SQA Services, Inc. January 2011 - December 2011
SQA Services, Inc. September 2009 - December 2010
Associated Students Program Board September 2007 - June 2008
Skills
Event Management, Program Management, Quality Assurance, Management, Six Sigma, Process Improvement, Quality Management, Negotiation, Coaching, Team Leadership, Cross-functional Team..., Project Management, Leadership, Project Planning, Team Building, Sales, Account Management, Quality Auditing, Software Documentation, Microsoft Office, Supply Chain Management, Manufacturing, Continuous Improvement, Business Development, Business Strategy, Enterprise Software
Education
UCLA Anderson School of Management 2014 — 2017
Master of Business Administration (M.B.A.)
UC Santa Barbara 2004 — 2008
Bachelor's degree, Business Economics, Minor in Sports Management
ViroPharma Incorporated 2009 - Present
Novartis Consumer Health February 2012 - April 2012
Laboratory Solutions May 2008 - February 2012
ilb Enterprises November 2007 - 2012
SQA Services, Inc. 2008 - August 2010
Pfizer December 2006 - February 2008
Bristol-Myers Squibb 2006 - 2008
Tunnell 2005 - 2008
Tunnell Consulting 2006 - 2007
Skills
GCP, Supplements, GMP, Regulatory Affairs, CRO, GLP, eCTD, Pharmaceutical Industry, FDA
Education
University of Alabama School of Medicine 1980 — 1986
S. G. Fabrectors April 2010 - Present
Digidesign September 2005 - November 2009
SQA Services, Inc. May 2004 - August 2005
Ajax Custom Manufacturing April 2002 - November 2002
The Ahmedabad Electricity Company January 1968 - February 1982
Skills
Quality Assurance, Project Management, Contract Negotiation, Process Control, Negotiation, Engineering, Testing
Education
L.D College of Engineering - Ahmedabad 1964 — 1967
Bachelor of Engineering (B.E.), Mecahnical Engineering
RINA Services Brasil 2007 - Present
Avaliadora Independente 2007 - Present
Qualitas Consultoria Ltda. 1994 - Present
SQA Services, Inc. 2000 - 2010
Skills
ISO 9001, ISO 14001, OHSAS 18001, ISO 13485, ISO/TS 16949, BPF, PBQP-H, Resoluções ANATEL, Quality Management, Supply Chain Management, GMP, Strategic Planning, Quality System, ISO, Business Strategy, Quality Auditing, Kaizen, FMEA, Business Planning, Microsoft Office, Project Management, Project Planning, Consulting, English, Italian, ISO 22000, FSC Certification
Education
FIA - Fundação Instituto de Administração 2008 — 2008
Especialização, Avaliação de Programas e Projetos Sociais
Universidade Estadual de Campinas 1987 — 1990
Master’s Degree, Logica e Filosofia da Ciência
Universidade Estadual de Campinas 1983 — 1986
Bachelor’s Degree, Física
Continental Automotive Systems September 2014 - Present
SQA Services, Inc. November 2013 - September 2014
Bosch April 2013 - November 2013
Bosch August 2011 - April 2013
Bosch November 2010 - August 2011
Bosch Rexroth June 2008 - November 2010
Bosch January 2005 - June 2008
Skills
FMEA, PPAP, APQP, TS16949, Supplier Quality, 8D Problem Solving, 5 Why, Automotive Engineering, Manufacturing, Engineering, Lean Manufacturing, Cross Functional Team..., Automotive, Value Stream Mapping, 5S, Kaizen, Continuous Improvement, SPC, DFMEA, Poka Yoke, ISO, Quality Control, ISO/TS 16949, Quality Management, Root Cause Analysis, Process Improvement
Education
Szent István Egyetem 1999 — 2004
Master's of Science, Mechanical Engineering
SQA Services, Inc. June 2014 - Present
Terrible Towers Consulting March 2014 - Present
ABC Inoac September 2012 - March 2014
General Plug & Manufacturing January 2010 - October 2012
North Coast Santa August 1998 - February 2010
Janesville Acoustics August 2006 - January 2009
The Plastics Group May 2004 - March 2006
Magnesium Aluminum Corporation March 2000 - May 2004
Commercial Vehicle Group 1998 - 2000
Shiloh Industries 1995 - 1998
Skills
Continuous Improvement, TS16949, ISO, Six Sigma, SPC, TQM, 5S, PPAP, FMEA, APQP, Manufacturing..., Quality Management, Lean Manufacturing, Kaizen, Supplier Quality, Quality System, Root Cause Analysis, ISO 14001, Value Stream Mapping, ISO/TS 16949, Quality Control, Operational Excellence, Poka Yoke, CAPA, Injection Molding, Industrial Engineering, Stamping, Management, Design of Experiments, ISO 13485, AS9100, Process Engineering, Iso 9000, Cost Reduction, Manufacturing Management, ISO 9100, Medical Devices, ISO 14971, Manufacturing, Process Improvement, Automotive, Manufacturing..., Cross-functional Team..., DMAIC
Education
Lorain County Community College 2009 — 2009
Cert, 6 Sigma Black Belt
The ExecuSearch Group June 2014 - Present
SQA Services, Inc. May 2014 - Present
ConvaTec September 2013 - April 2014
Enterix Inc, a Quest Diagnostics Company September 2012 - August 2013
Enterix, A Quest Diagnostics Company May 2006 - September 2012
Sanofi-Aventis, March 2004 - March 2006
Almedica Services Corp., Allendale, NJ August 2002 - February 2004
Ortec International, Inc. April 2001 - July 2002
Howmedica Osteonics. a division of Pfizer May 1984 - March 2001
Skills
GMP, FDA, Quality Assurance, Software Documentation, Root Cause Analysis, Validation, Sop, Medical Devices, Change Control, ISO, ISO 13485, GDP, Compliance, CAPA, Complaint Management, Employee Training, Remediation, Internal Audit, External Audit, Document Management, Batch Release, Complaint Investigations, Corrective Actions, Preventive Actions, ISO Management..., Consent Decree, Trackwise, Pilgrim, Siebel, Deviations, Regulatory Requirements, Gap Analysis, SOP authoring, MDRs, Team Leadership, Metrics Reporting, Management Review, Customer Service, Operations Management, Packaging Artwork, Supplier Quality..., Third Party Inspection, Regulatory Interactions, Pharmaceutical Industry, Quality System, SOP
Education
New York University
SQA Services, Inc. May 2012 - Present
Novo Nordisk A/S January 2009 - May 2010
Johnston Community College 2005 - 2008
Purdue Pharma L.P. August 1999 - May 2004
Southern Testing and laboratory August 1994 - August 1999
Skills
Analytical Chemistry, GMP, Chromatography, HPLC, Chemistry, Pharmaceutical Industry, FDA GMP inspections and..., UV/Vis, Research, Validation
Education
University of Mississippi 1991 — 1994
Master’s Degree, Analytical Chemistry
East China University of Science and Technology 1981 — 1985
Bachelor’s Degree, Chemical Engineering
Merz North America August 2015 - Present
SQA Services, Inc. April 2015 - August 2015
Merz North America, Inc August 2013 - April 2015
Merz North America, Inc 2010 - 2013
Hospira, Inc. 2005 - 2010
Abbott Laboratories 1989 - 2005
Skills
CAPA, Medical Devices, Quality Assurance, Pharmaceutical Industry, FDA, Regulatory Affairs, V&V, Design Control, Validation, Product Launch, Sop, Risk Management, Quality System, Quality Auditing, Regulatory Requirements, Software Documentation, ISO 13485, Change Control, GMP, Six Sigma, Quality Management, Process Improvement, Quality Control, Regulatory Submissions, Lean Manufacturing, Technical Complaints, Contract Manufacturing, FDA Audits, Technical Writing
Education
University of Wisconsin-Parkside 1986 — 1989
BS
Gateway Technical College
LPN
Team Industrial Services September 2015 - Present
WESTLAND MANUFACTURING February 2013 - July 2015
SQA Services, Inc. August 2015 - 2015
DMI Industries February 2011 - October 2012
DMI Industries July 2008 - February 2011
BH Electronics January 2008 - July 2008
Skills
Quality Control, Quality System, Testing, Quality Assurance, Manufacturing, Root Cause Analysis, Continuous Improvement
Education
AINDT -American Institute of Nondestructive Testing 2015 — 2015
Certificate, VT, MT, PT, UT and RT
Southwest Minnesota State University 2003 — 2007
Bachelor of Science (BS), Business Administration and Management, General
UL July 2012 - Present
SQA Services, Inc. August 2011 - Present
West Pharmaceutical Services 2006 - 2009
West Pharmaceutical Services 2003 - 2006
West Pharmaceutical Services 2001 - 2003
West Pharmaceutical Services 1995 - 2001
Skills
Policy Writing, cGMP, Quality Auditing, Quality Systems, ISO, SOP, Technical Writing, GMP, Sop, Quality System, Continuous Improvement, FDA, Validation
Education
Rowan University 1972 — 1976
BA, Life Sciences
Philips Medical Systems North America Inc. December 2014 - Present
SQA Services, Inc. September 2014 - December 2014
BenVenue September 2002 - December 2013
Benvenue Medical September 2002 - December 2004
Bedford Anodizing June 1986 - September 2002
Skills
Sop, cGMP practices, CAPA, Visual Inspection, Trackwise, Pharmaceutics, Software Documentation, Equipment Qualification, FDA GMP, Inspection, Deviations, cGMP manufacturing, Aseptic Technique, TrackWise, GMP, Quality Assurance, Pharmaceutical Industry, FDA, Validation, Change Control, 21 CFR Part 11, Quality System, Biotechnology, Medical Devices
Education
Cuyahoga Community College 2012 — 2016
Associates of Science, Environmental Science, "B"
Bedford High School 1977 — 1980
SQA Services, Inc. September 2013 - Present
SCS Fabrication February 2013 - September 2013
Logik Precision April 2011 - February 2013
General Plastics & Composites LP October 2010 - April 2011
Schlumberger June 2010 - August 2010
T.A.W. Manufacturing October 2009 - June 2010
Alloy Carbide April 2005 - June 2009
Skills
Inspection Coordination, Source Inspection, Oil & Gas, GD&T, Mechanical Inspection, Machining, Engineering, Mastercam/ Cam software, 3D Modeling & 2D..., Solidworks/ Cad software, FaroArm, ASME, NDE, ASNT, ASTM, Welding Inspection, CNC Mill & Lathe, Data Management, Continuous Improvement, Calibration, CNC Programming, Cnc, CNC, Metal Fabrication, AutoCAD, Lean Manufacturing, Geometric Dimensioning...
Education
CNC Software,Inc. 2012 — 2012
Certification in Mastercam Multiaxis Training, CNC Programming
San Jacinto College 2004 — 2005
Certification in Engineering Graphics Design, Mechanical Engineering
C.E.king High 2000 — 2004
High School Dipolma
Cai Lun Management March 2015 - Present
SQA Services, Inc. 2014 - 2015
The RyTE Professionals March 2014 - October 2014
Experian 2010 - 2013
Southern California Edison (SCE) 2008 - 2010
Education
California State University-Long Beach 2006 — 2010
Bachelors of Science, Criminal Justice/Police Science
California State University-Long Beach 2006 — 2010
Bachelor of Science (B.S.), Criminal Justice/Police Science