Experience
Validant   July 2014 - Present
Sandoz  April 2007 - May 2014
Sandoz  April 2007 - October 2010
Columbia Analytical Services  March 2006 - February 2007
Green Analytical Chemistry Inc   May 2005 - March 2006

Skills
Competent in Current..., HPLC, Analytical Method..., Dissolution, Process Validation, Analytical Chemistry, GMP, LIMS, GLP, Titration, Chromatography, USP, V&V, UV, UV/Vis, Sop, Validation, SOP, Pharmaceutical Industry, FDA, 21 CFR Part 11

Education
Fort Lewis College   1999 — 2004
Bachelor of Science (B.S.), Chemistry

Experience
Validant   April 2014 - May 2015
ProPharma Group  June 2013 - February 2014
Tolmar Inc.  September 2011 - March 2013
Oso BioPharmaceuticals Manufacturing, LLC  January 2009 - December 2010
Talecris Biotherapeutics, Inc.   August 2000 - May 2007

Skills
Project Management, Statistical Data..., Technical Writing, Compliance management, Training program design, Operational..., Regulatory Agency Audits, Hiring top talent, Agilent Chemstation..., ROI analyses, Smartsolve and..., SQL based LIMS systems, Supervising and..., cGMP in Analytical..., Managing laboratory..., Operational SOP..., Team-building, HPLC methods, CAPA design, QC and MFG Partnerships, Microsoft Office and..., Equipment qualification..., Root Cause Analysis, Deviation report writing, Quality Systems, Parenteral, Solid-Dose,..., Quality System, Talent Management, Training, GMP, LIMS, Quality Control, HPLC, Pharmaceutical Industry, Chemistry, Software Documentation, Team Building, Quality Assurance, Laboratory, FDA, CAPA, Validation, SOP

Education
North Carolina State University - College of Management   2006 — 2012
MBA, Management and Finance

Wofford College   1981 — 1985
B.S., Chemistry

Experience
The City of Calgary  November 2014 - Present
SourceDogg   April 2013 - September 2014
SourceDogg   April 2013 - July 2013
Validant   May 2012 - January 2013
Toys4you Stores and Website   July 2011 - February 2012
CIBC  June 2010 - September 2010
BEF Property, Galway, Ireland and Nice, France.   2002 - 2009

Skills
Supply Chain Management, Management, Business Strategy, Strategy, Business Systems..., Analysis, Digital Marketing, New Business Development, PowerPoint, Microsoft Excel, Business Development, Finance, Marketing, Business Analysis, Corporate Finance, Microsoft Word, Market Research, International Business..., Marketing Strategy, Intercultural..., Business Communications, Word, Website Development, Cygwin, SQL Server Management..., Scrum Master, SSIS, TFS, Data Modeling, SEM, SEO, SDLC, Sprint Planning, jQuery, CSS, Bootstrap, HTML, Quality Assurance, Bug Tracking, Logistics, Procurement, Government Procurement, E-procurement, EPC, SAP ERP, Project Management

Education
National University of Ireland, Galway   2010 — 2011
Master of Science (M.Sc.), International Management, 2.1 2nd class honors grade 1

Galway-Mayo Institute of Technology   2008 — 2009
Bachelor's degree, Business Studies and Marketing, 2.1 2nd class honors grade 1

Ipag Business School   2007 — 2008
Advanced Diploma, International Business, 2.1 2nd class honors grade 1

Academy of Financial Trading   2013 — 2013
Financial Trading Programme

New York Institute of Finance   2012 — 2012
Fixed Income Markets, 3.6

Yeats College   2002 — 2003
Leaving Certificate

Experience
HealthSTAR Communications  August 2014 - Present
Validant   August 2013 - Present
Affymax  May 2012 - April 2013

Skills
Biotechnology, Dialysis, FDA, Medical Devices, Nephrology, Pharmaceutical Industry, Clinical Research, Clinical Development, Clinical Trials, GCP, Healthcare, Diabetes, Medical Affairs, Pharmaceutical Sales, Healthcare Management, Nursing, Cardiology

Education
Bellevue University   2001 — 2003
Master of Business Administration (MBA), Health/Health Care Administration/Management

University of North Carolina at Wilmington   1992 — 1996
Bachelor of Science (BS), Registered Nursing/Registered Nurse

Experience
Calgaz, a division of Air Liquide   October 2014 - Present
Consulting Services  February 2006 - October 2014
Validant   March 2012 - February 2014
First Quality  January 2011 - October 2011
ZeroChaos  April 2008 - December 2008
Fluor  February 2006 - November 2007
Merck  December 1996 - February 2006
US Army  1981 - 1991

Skills
Pharmaceutical Industry, FDA, Quality Assurance, GMP, Quality System, Process Improvement, Training, Continuous Improvement, Biotechnology, Sop, Cross-functional Team..., Regulatory Requirements, Consent Decree, Compliance Remediation, FDA GMP, American Society for..., Workforce Education, Corporate Training, TESOL, Accent Reduction, 21 CFR Part 11, Manufacturing, Change Control, Gap Analysis, Quality Auditing, Document Management, Documentum, Technical Writing, Lifesciences, Technical Training, Employee Training, Training Delivery, Onboarding, ADDIE, Instructor-led Training, Instructional Design, Aseptic Processing, Regulatory Affairs, GxP, SOP, Life Sciences

Education
Barton College   1992 — 1996
BS & BA, Business Management & Hispanic Studies/Spanish, 4.0/3.9

American InterContinental University
Master of Education (M.Ed.), Curriculum and Instruction (50% complete)

Experience
Redapt, Inc.   February 2015 - Present
Validant   November 2011 - January 2015
Extended Day Child Care   June 2009 - November 2011
Pleasanton Unified School District  December 2009 - September 2011
Abercrombie & Fitch  January 2005 - June 2009

Skills
Project Management, Validation, Biotechnology, Quality System, FDA, Medical Devices, Leadership, Cross-functional Team..., Regulatory Affairs, Quality Auditing, Technical Recruiting, ISO, Manufacturing, 21 CFR Part 11, Six Sigma, ISO 13485, R&D, V&V, CAPA, Quality Assurance, Lean Manufacturing, Process Engineering, Clinical Trials, SPC, Consulting, Continuous Improvement, Design of Experiments, Pharmaceutical Industry, Pharmaceutics, Change Control, GMP, Quality Control, GLP, Sop, Minitab, Quality Management, Lifesciences, Product Launch, Process Improvement, Root Cause Analysis, Process Simulation, Software Documentation, Auditing, Product Development

Education
California State University-Chico   2005 — 2009
Bachelor's Degree, Psychology

California State University-Chico   2005 — 2009
Bachelor's Degree, Child Development

Experience
Validant   2013 - Present
Validant   2013 - May 2014
Validant   2013 - October 2013
American Indian Model Schools  September 2012 - 2013
American Indian Public Charter School I   June 2012 - 2013
American Indian Public Charter School II  2010 - 2012

Skills
Research, Management, Training, Data Analysis, Analysis, Microsoft Office, Recruiting, Public Speaking, Teaching, Leadership, Event Planning, Curriculum Design, Microsoft Excel, PowerPoint, Social Media, Microsoft Word, Customer Service, Editing, Strategic Planning, Pharmaceutical Industry, FDA, Biotechnology, Curriculum Development, Leadership Development, Educational Leadership, Community Outreach, Nonprofits, Social Networking, Lesson Planning, Educational Technology, Public Relations, Classroom, Teacher Training, Team Leadership, Classroom Management, Facebook, Differentiated..., Literacy, Python

Education
University of California, Berkeley
Bachelor of Arts, Economics

Alliant International University-San Francisco Bay
California Multiple Subjects Teaching Credential, Education

University of Michigan   2015 — 2015
Coursera/10-Week MOOC, Python

Experience
Validant   June 2012 - November 2012
EMD Millipore Corporation  January 2012 - June 2012
EMD Millipore  August 2010 - January 2012
Millipore  November 2009 - August 2010
Thermo Fisher Scientific  May 2006 - November 2009
Thermo Fisher Scientific  January 2005 - May 2006
Philips Healthcare  July 2003 - December 2004
Agilent Technologies  January 2001 - July 2003

Skills
Strategic Planning, Services Marketing, Business Plan..., Services Management, Portfolio Management, Thought Leadership, Process Improvement, Customer Retention, Contract Management, Business Planning, Service Management, Management, CRM, Product Management, Marketing Management, Strategy, Program Management, Competitive Analysis, Product Development, Budgets, Product Launch, Cross-functional Team..., Medical Devices, Six Sigma, Training, Sales Management, Team Leadership, Market Research, Leadership, Business Development, Marketing Strategy, Sales Operations, Marketing, Marketing Communications, Pricing, Market Planning, Sales, Analysis, Integrated Marketing, Go-to-market Strategy, Operations Management, Market Analysis, Brand Management

Education
Simmons College - Simmons School of Management   1994 — 1996
Masters, Business Administration

Boston University   1990 — 1992
B.S., Mass Communication

University of Massachusetts, Amherst   1988 — 1990

National Laser Institute

Experience
Alcon Laboratories, Inc.   January 2013 - Present
Alcon Laboratories, a Novartis company  June 2012 - Present
Alcon Laboratories, a Novartis company  July 2011 - June 2012
CIBA Vision  April 2010 - July 2011
Validant   February 2009 - January 2010
Cordis  August 2007 - May 2008
Cordis  March 1990 - April 2007

Skills
FDA, CAPA, Quality System, ISO 13485, Regulatory Affairs, Medical Devices, Pharmaceutical Industry, Quality Auditing, Quality Assurance, Regulatory Requirements, Design Control, Manufacturing, Six Sigma, Quality Management, V&V, Design of Experiments, GLP, GMP, Validation, Continuous Improvement, Process Improvement, Sop, 21 CFR Part 11, Quality Control, ISO 14971, Regulatory Submissions, Computer System..., GxP, Change Control, Aseptic Processing, ISO, Technology Transfer, SOP

Education
University of Phoenix
B.S., Business Management

Miami Dade College
Associate of Science (A.S.), Business Administration and Management, General

Experience
BFH Consulting, LLC   February 2011 - Present
Validant   April 2014 - Present
ALKU  December 2013 - March 2014
Validant   April 2013 - November 2013
Validant   August 2011 - April 2013
Abbott Laboratories  June 2009 - January 2011
Abbott Laboratories  February 2004 - May 2009
Abbott Laboratories  January 2002 - January 2004
Abbott Diagnostics  1989 - 2001
Abbott Laboratories  May 1983 - June 1989

Skills
CAPA, FDA, Nutrition, Pharmaceutical Industry, ISO 13485, Medical Devices, 21 CFR Part 820, Quality System, Validation, V&V, GMP, International Operations, Regulatory Affairs, Quality Assurance, Process Improvement, Cross-functional Team..., Technology Transfer, Quality Auditing, Change Control, ISO 14971, ISO, R&D, Product Development, 21 CFR Part 11, Quality Management, Manufacturing, FMEA, Product Launch, Testing, Quality Control, Sop, Root Cause Analysis, GLP, Biomedical Engineering, Design of Experiments, DMAIC, Supply Chain, SPC, Cold Chain, Packaging Engineering, Process Simulation, Supply Chain Management, Six Sigma, SOP

Education
Purdue University Calumet
Bachelor's degree, Electrical Engineering Technology

DePaul University
Business Administration, Management and Operations

Experience
ETHICON Johnson & Johnson  June 2015 - Present
Thermofisher Scientific  November 2014 - March 2015
Baxter Healthcare via USDM   October 2011 - December 2013
Leica Microsystems  January 2011 - June 2011
Regulatory Compliance Associates, Inc.   August 2010 - January 2011
US Data Management  January 2009 - November 2010
US Data Management  November 2009 - May 2010
2009 - 2009 Validant Consulting   November 2009 - May 2010
Validant   July 2009 - October 2009
Cardinal Health  May 2006 - August 2008

Skills
CAPA, FDA, V&V, Quality System, Software Documentation, Root Cause Analysis, 21 CFR Part 11, Validation, GMP, Change Control, Sop, Pharmaceutical Industry, Biotechnology, Calibration, Computer System..., Cross-functional Team..., Design Control, FMEA, GLP, GxP, Hardware Diagnostics, ISO, ISO 13485, LIMS, Lifesciences, Manufacturing, Medical Devices, Pharmaceutics, Process Improvement, Quality Assurance, Quality Auditing, Quality Control, Regulatory Affairs, Regulatory Requirements, Six Sigma, Technical Writing, Testing, Trackwise, Documentation, Training, Continuous Improvement, Document Management

Education
Illinois State University   1993 — 1995
Bachelor, Biology

in Medical Laboratory Technology @ CLC   1993 — 1995
Bachelor of ScienceAssociate of Applied Science, Biology @ ISU

Experience
Validant   September 2014 - Present
R&Q  June 2014 - September 2014
Maetrics, LLC  January 2014 - June 2014
Hospira  January 2012 - January 2014
Ethicon Endo-Surgery  April 2010 - January 2012
Mercy Mt. Airy Hospital   August 2009 - December 2011
Riverhills Healthcare, Inc.   October 2008 - August 2009
Innovex  April 2005 - November 2007

Skills
Clinical Research, Cardiology, Healthcare, Medical Devices, Oncology, Hospitals, Clinical Trials, Surgery, Neurology, Medicine, Managed Care, Critical Care, Diabetes, Patient Safety, FDA, Regulatory Affairs, Pharmaceutical Industry, ISO 13485, CAPA, SOP, GCP

Education
Concordia University-Wisconsin   2002 — 2005
BSN, Nursing

Experience
The FDA Group   April 2014 - Present
Oxford Global Resources  February 2014 - Present
Validant   September 2013 - Present
ASQ  1993 - Present
American Society for Quality  1993 - 2014
Tunstall Americas  February 2013 - August 2013
Sealed Air Corporation  March 2010 - January 2013
CR Bard  August 1990 - March 2010
SCOTT Laboratories  April 1985 - August 1990
National Cancer Institute  June 1977 - April 1985

Skills
Quality System, ISO 13485, FDA, Quality Management, Root Cause Analysis, Validation, Six Sigma, CAPA, ISO, Medical Devices, GMP, DMAIC, Process Improvement, Lean Manufacturing, ISO 9001, Quality Assurance, Quality Auditing, V&V, Sterilization, Controlled Environments, Aseptic Processing, CQA, SPC, TQM, Cleaning Validation, Supplier Quality, Design Control, Design of Experiments, Process Engineering, Kanban, Regulatory Affairs, FMEA, ASQ, Value Stream Mapping, Operational Excellence, 5S, Microbiology, ISO 14001, Manufacturing, Calibration, Biocompatibility, Six Sigma Black Belt, Continuous Improvement, Mammalian Cell Culture, Minitab, Kaizen, Change Control, Quality Control, ISO 14971, Iso 9000

Education
Anna Maria College   1994 — 1995
MS, Quality Management

Penn State University   1971 — 1976
BS/BS, Biology & Microbiology

Experience
EG Life Sciences  June 2015 - Present
Validant   February 2014 - May 2015
Vapotherm  January 2013 - December 2013
Vapotherm, Inc   August 2009 - December 2012
DENTSPLY International  January 2007 - July 2009
Delaware State Parks  October 2005 - December 2006
Honeywell International  August 2002 - May 2005
MCV Physical Therapy Lab   June 2002 - August 2002
Virginia Commonwealth University  January 2001 - May 2002

Skills
Regulatory Affairs, Product Development, Technical Support, Medical Devices, FDA, Biomedical Engineering, ISO 13485, Design Control, Validation, Lifesciences, CAPA, Quality System, Manufacturing, Cross-functional Team..., Six Sigma, Lean Manufacturing, Sop, Design of Experiments, V&V, Quality Assurance

Education
Johns Hopkins University Advanced Academic Programs   2013 — 2016
Master's degree, Biotechnology Enterprise/Entrepreneurship

Villanova University   2010 — 2011
Certificate, Lean/Six Sigma

Virginia Commonwealth University   2000 — 2005
B.S., Biomedical Engineering

Experience
Black Diamond Networks  October 2014 - April 2015
Radiant Systems Inc.  March 2014 - June 2014
Validant   April 2013 - July 2013
Validant   June 2012 - March 2013
Engineering & Research Associates   January 2011 - June 2011
Ventana Medical Systems Inc  October 2007 - January 2011
Westmed Inc  June 2005 - October 2007
Modern Engineering  April 2002 - September 2003
Abbott Laboratories  August 1993 - July 2001

Skills
Electronics, Validation, RF, Diagnostics, Medical Devices, Lean Manufacturing, Manufacturing, Product Development, Engineering, Testing, AutoCAD, Solidworks, Process Development, Troubleshooting, Assembly, Automation, Supervisory Skills, Process Improvement, Process Engineering, Problem Solving, Quality Assurance, Program Management, Documentation, FDA, PLC, Root Cause Analysis, Software Documentation, Cross-functional Team..., Quality System, Quality Control, Minitab, V&V, Sop, Injection Molding, Process Simulation, ISO 13485, 5S, Design Control, FMEA, Manufacturing..., CAPA, Hardware Diagnostics, Project Management, Manufacturing..., Kaizen, Supply Chain, Design for Manufacturing, 21 CFR, GMP, Iso 9000

Education
Arizona State University   1972 — 1975
Bachelor of Science (B.S.), Electronic Technology

Experience
Center for Employment Opportunities  September 2013 - Present
3 Bridge Networks   April 2013 - July 2013
Validant   September 2011 - August 2012
Validant   February 2011 - September 2011
The Ascent Services Group  2010 - 2010

Skills
Pharmaceutics, Research, Cross-functional Team..., Technical Recruiting, Recruiting, CAPA, Quality Assurance, Change Management, Management Consulting, Strategy, Temporary Placement, Quality System, Program Management, Enterprise Software, Process Improvement, Project Management, Sourcing, 21 CFR Part 11, Consulting, Temporary Staffing, Training

Education
University of California, Berkeley   2007 — 2009
B.A., Sociology

Contra Costa College   2005 — 2007
General Education and Sociology

F.I.D.M. Fashion Institute of Design and Merchandising   2003 — 2005
Associate of Arts (A.A.), Business Merchandise and Marketing

Experience
SeaSpine   March 2015 - Present
Maetrics  October 2013 - April 2015
Allergan Medical  November 2012 - June 2013
Terumo  April 2011 - November 2012
Validant   October 2010 - November 2012
Hospira  2010 - 2011
Abbott Vascular Devices  April 2006 - June 2010
Advanced Bionics  April 2005 - March 2006
TUV America  March 2003 - March 2005
Advanced Sterilization   2002 - 2003

Skills
Quality Systems, Supplier Quality, Business Process..., ISO 13485, Training, Management Review, CAPA, FDA, Quality System, Document Management, Quality Management, V&V, Internal Audit, GMP, Adverse Event Reporting, Medical Devices, Quality Assurance, Quality Auditing, Design Control, ISO 14971, Root Cause Analysis, Six Sigma, GxP, Iso 9000, ISO, SPC, Risk Management, 21 CFR Part 11, Quality Control, Biotechnology, FMEA, Process Improvement, Software Documentation, Validation, Manufacturing, Aseptic Processing, Cross-functional Team..., Change Control, Auditing, Computer System..., Sop, Regulatory Submissions, Regulatory Affairs, R&D, Pharmaceutical Industry, Technology Transfer, GLP, Clinical Trials, Process Simulation, Biopharmaceuticals

Education
University of Phoenix   2006 — 2009
MBA, Business

California State University-Long Beach   1972 — 1976
BSIT, Quality Asssurance Specialty

Experience
Integra LifeSciences  October 2014 - Present
Validant   May 2014 - October 2014
LifeCell Corporation  July 2013 - May 2014
LifeCell Corporation  November 2009 - July 2013
Our Lady of Lourdes Health Care System   May 2007 - November 2009
Gife of Life Donor Program   September 2003 - May 2007
The Julian Krinsky Group  June 2003 - July 2006
Deborah Heart and Lung Center/ Deborah Hospital  January 1991 - September 2003
United States Army Reserve  June 1988 - April 2000
Robert Wood Johnsson University Hospital Hamilton  January 1989 - January 1991

Skills
Quality Assurance, Donor Suitability, Documentation Practices, Nursing Documentation, QA Documentation, Change Control, Process Quality..., Critical Care, Quality Patient Care, Organ and Tissue..., Transplant, Clinical Research, EMS, Process Improvement, Healthcare, Software Documentation, Cross-functional Team..., Hospitals, Healthcare Management, Surgery, ACLS, Nursing, Kidney Transplant, BLS, Project Management, FDA, Managed Care, Nursing Education, Oncology, Clinical Trials, Medical Devices, Cardiology, Orthopedic, Medical/Surgical, ICU, Medicine, Infectious Diseases, Biotechnology, Cancer, EMR, Patient Safety

Education
University of Phoenix   2013 — 2016
MHA-Informatics, Healthcare Administration/Informatics

The College of New Jersey   1985 — 1988
BSN, Nursing

Michigan State University   1982 — 1984
pre-nursing

Experience
Novartis Animal Health  November 2012 - Present
Validant   April 2012 - November 2012
Biogen Idec  July 2011 - April 2012
GlaxoSmithKline  August 2007 - July 2011
GSK  2007 - July 2011
Abraxis Oncology  March 2007 - August 2007
DanChem Technologies, Inc.   2004 - 2007
Wyeth  February 2001 - September 2006
AAI Development Services  December 1998 - February 2001

Skills
FDA, CAPA, Validation, Quality Assurance, SOP, Change Control, GMP, Quality System, Pharmaceutical Industry, Quality Auditing

Education
North Carolina Agricultural and Technical State University   1990 — 1997
Bachelor of Science (BS), Chemistry

Experience
REI  October 2012 - Present
Long and Foster  March 2011 - 2013
The Proper Property Proprietary   February 2011 - 2013
Episcopal High School  February 2011 - June 2012
CAL Sailing   March 2010 - June 2010
Validant   October 2009 - March 2010
"Ride!" They Cried   May 2009 - August 2009
Burke & Herbert Bank & Trust   January 2009 - May 2009
Pacific Expeditions Ltd.   February 2008 - April 2008
Austin Grill  May 2006 - August 2006

Skills
VA Real Estate Lisence, Microsoft Office, Photoshop, HTML, Website Development, Business Communications, Conflict Resolution, Real Estate, Team Building, Market Research, Coaching, Management, Customer Service, Public Relations, Social Media, Nonprofits, Teaching

Education
Northern Virginia Community College   2011 — 2011
Automotive Engineering

Bond University   2007 — 2008

University of Mary Washington   2004 — 2008
Bachelor of Science, Business Administration

Experience
LexaMed  February 2014 - Present
Synergy Health   July 2012 - December 2013
Medtronic  December 2011 - July 2012
Validant   December 2010 - December 2011
Maetrics LLC  April 2008 - December 2010
LexaMed  November 2007 - April 2008
J & J Scientific Products   February 2007 - December 2007
Baxter Healthcare  February 2005 - January 2007
MasterTaste  November 2003 - December 2004
ASO Corporation   June 2001 - November 2003

Skills
CAPA, Validation, FDA, ISO 13485, Medical Devices, V&V, Quality System, FMEA, Manufacturing, Regulatory Affairs, Continuous Improvement, Quality Assurance, SPC, ISO, Sop, Quality Auditing, Change Control, GMP

Education
Gannon University   1981 — 1985
Bachelor of Science, Biology

Experience
Oxford International  July 2015 - Present
PharmaBio Serv   June 2015 - July 2015
Maetrics, LLC  March 2013 - December 2014
Validant   July 2012 - March 2013
Piramal Critical Care, Inc  October 2010 - June 2012
Validant   March 2010 - October 2010
Halo Pharmaceuticals, Inc.   January 2009 - April 2010
Abbott Laboratories  August 2003 - December 2008

Skills
Quality Management, Quality Systems Design, Quality System..., cGMP practices, CFR Part 210 & 211, CFR 21 Part 820, ISO 13485, Quality Auditing, ICH guidelines, Validation, FDA, Quality Assurance, FDA GMP, Quality Control, Quality System, GxP, CAPA, GMP, Six Sigma, Medical Devices, Root Cause Analysis, Cross-functional Team..., 21 CFR Part 11, Pharmaceutical Industry, Regulatory Affairs, SOP, Change Control, GLP, V&V, Process Improvement

Education
Lehigh University - College of Business and Economics   1997 — 2002
MBA, General Administration

Penn State University   1968 — 1972
Bachelor's degree, Ceramic Sciences and Engineering

Experience
consultancy  October 2014 - Present
Validant   May 2013 - Present
Boston Scientific  2014 - 2015
Boston Scientific  2014 - 2015
Boston Scientific  2014 - 2015
Boston Scientific  2014 - 2015
Varian Medical Systems  2013 - 2014
Philips  January 2011 - November 2011
Consultant, Anson Group   July 2010 - January 2011
none  February 2008 - April 2010

Skills
Medical Devices, ISO 13485, FDA, Regulatory Affairs, Validation, Quality Assurance, Quality Auditing, Biotechnology, Pharmaceutical Industry, Cross-functional Team..., 21 CFR Part 11, R&D, Process Improvement, Sop, Product Launch, ISO, CAPA, Quality System, Training, Auditing, Complaint Management, ISO 14971, GMP

Education
California State University-San Marcos   2003 — 2004
Bachelor of Arts (BA), Social Psychology

Southern Cross University   2003 — 2003
Exercise Science, Kinestheology

Experience
Fresenius Medical Care  November 2014 - Present
Validant   August 2014 - November 2014
DOHMEN  March 2014 - June 2014
Maetrics, LLC  January 2013 - October 2013
HeartWare Inc  March 2011 - March 2012
Cordis Corporation  February 2005 - March 2011
Baxter Healthcare Corporation  January 1999 - January 2001

Skills
Medical Devices, Validation, ISO 13485, FDA, Quality System, Quality Assurance, CAPA, Quality Management, 21 CFR, GMP, ISO 14971, V, Complaint Management, Software Documentation, Sop, V&V, Regulatory Affairs

Education
Florida International University   2006 — 2008
Bachelors, International Business and Management

Experience
Charming Charlie  March 2015 - July 2015
Manduka  November 2013 - January 2015
Manduka  November 2011 - November 2013
Manduka  March 2011 - November 2011
Validant   March 2010 - February 2011
Aronowitz & Mecklenburg   December 2008 - January 2010

Skills
Marketing, Research, Content Marketing, Promotions, Eblasts, Google Analytics, Spanish, Foreign Languages, Problem Solving, Teamwork, Communication, Microsoft Excel, Microsoft Word, Outlook, PowerPoint, Organization, Troubleshooting, Meet Deadlines, Fast-paced, Social Media Marketing, Event Management, Retail, Customer Service, Advertising, Blogging, Social Media, Management, Copywriting

Education
Colorado State University   2004 — 2008
Business/Marketing, Marketing

University College Dublin   2006 — 2007
Marketing, International Business/Marketing

Hola Spanish in Buenos Aires
Spanish

Experience
General Assembly  September 2015 - Present
Freelance  April 2015 - Present
Wheel House  April 2015 - Present
Validant   April 2013 - August 2015
Nanosolar  November 2012 - February 2013
University of Vermont  June 2010 - August 2012

Skills
Sketch, User Experience Design, Visual Design, Design Thinking, Rapid Prototyping, InVision, User Experience, Interaction Design, Graphic Design, Adobe Creative Suite, Designing, Research, Illustrator, Data Analysis, Vector Illustration, Ecology, Microsoft Office, Field Work, Chemistry, Laboratory, Data Entry, Biology, Experimental Design, Environmental Science, Performance Metrics, Aquatic Ecology, Taxonomy, Database Integrity, Cross-functional Team..., Kicking Ass, Scientific Writing, Ecological Research, Social Media, Management, Leadership, Customer Service, Database Administration, Applicant Tracking...

Education
General Assembly
User Experience Design Immersive

General Assembly
Visual Design

University of Vermont
Bachelor of Arts (B.A.), Biology, Chemistry, Studio Art

Experience
ProPharma Group  July 2014 - Present
Validant   2012 - 2014
Lab Support, a division of On Assignment  August 2010 - November 2012
Opus Regulatory   August 2005 - April 2010
Cambridge Search   2001 - 2005
Modis  1999 - 2001

Skills
Biotechnology, Packaging, Diagnostic, Chemical, Contract Testing Lab, Environmental, Industrial Manufacturing, Medical Device, Medical Research Labs, Pharmaceutical, Computer System..., Validation, Cleaning Validation, Process Improvement, Quality Assurance, Regulatory Affairs, Global Regulatory..., Medical Information..., Complaint Management, Commissioning, Technology Transfer, Compliance, Manufacturing Operations, Process Engineering, Program Management, Project Management, Business Development

Education
Colby College   1990 — 1994
BA

Experience
Delta Project Management  May 2014 - Present
Validant   April 2012 - May 2014
Art Institute of California - San Francisco  August 2011 - April 2012
Academy of Art University  September 2008 - October 2010
American InterContinental University  September 2007 - September 2008
CareerBuilder.com  May 2007 - September 2007

Skills
Academia, Salesforce.com, Student Development, Interviews, Process Improvement, Human Resources, Analysis, Campus, Cross-functional Team..., Strategy, Employee Training, V&V, Project Planning, Consulting, GMP, Technical Recruiting, Staff Development, Admissions, Validation, Biotechnology, FDA, Leadership, Management, Pharmaceutical Industry

Education
North Park University   2003 — 2007
Bachelor of Arts (B.A.), Sociology

Experience
Validant   September 2015 - Present
Kredible  April 2014 - September 2015
Anteo Group/CSI Companies, a unit of Recruit Holdings Co. Ltd.   September 2013 - March 2014
Anteo Group  2002 - September 2013
Allegis Group  January 2001 - May 2002
Allegis Group London U.K.   July 1996 - December 2000
Andlock, BV Netherlands   May 1995 - December 2000

Skills
Strategy, Strategic Planning, Leadership, Change Management, Start-ups, Project Management, IT Strategy, CRM, Integration, Operational Excellence, PMO, Vendor Management, Strategic Consulting, Management Consulting, Professional Services, Business Process..., Business Intelligence, Technology Planning, Technology Evaluation, Program Management, SaaS, Technology..., Business Continuity, IT Service Management, Business Development

Education
Hope College   1988 — 1992
B.A., Business

Experience
Dohmen Life Science Services  January 2015 - Present
Cincero Investment Properties, Inc.   January 2014 - Present
Validant   July 2014 - January 2015
Carefusion  July 2011 - July 2014
Mentor Corporation  April 2009 - May 2011
Medtronic  August 2007 - April 2009
Johnson & Johnson  July 2004 - August 2007
Janssen Pharmaceutica  April 2001 - July 2004
Elgie Inc.   August 2000 - March 2001
Johnson & Johnson Medical  October 1996 - August 2000

Skills
GMP, V&V, Quality Assurance, Change Control, Design Control, Six Sigma, Quality Auditing, ISO 14971, Quality Control, R&D, Regulatory Submissions, Product Development, Lean Manufacturing, GLP, GxP, Regulatory Requirements, Quality Management, DMAIC, FDA, CAPA, Validation, Quality System, Medical Devices, ISO 13485, Pharmaceutical Industry

Education
Baylor University   1985 — 1990
MS, Chemistry

Texas Wesleyan University   1981 — 1985
B.S., Chemistry

Experience
Validant   December 2013 - Present
Validant   2011 - December 2013
Bay Equity, LLC  April 2010 - October 2011
Guide Dogs for the Blind  June 2009 - June 2010
Plaid Ranch LLC   June 2003 - June 2008
LicenZing LLC   September 2006 - May 2007

Skills
Customer Service, Research, File Management, Newsletters, Press Releases, Database Administration, Employee Relations, HRIS, Benefits Administration, Applicant Tracking..., Talent Acquisition, ADP Payroll, Payroll, FMLA, Onboarding, Deferred Compensation, Interviews, Workforce Planning, Recruiting, Public Relations, Technical Recruiting, Team Building, Training, HR Policies, Personnel Management, Employee Training, Talent Management, Performance Management, Human Resources, Process Improvement, Microsoft Office

Education
Cornell University School of Industrial and Labor Relations   2009 — 2010
Certificate, Human Resources Studies

Dominican University of California   2004 — 2008
BA, Communications

Experience
Force Brands - BevForce FoodForce FieldForce  January 2015 - Present
Experis  April 2011 - January 2015
Hays Finance Technology   January 2011 - March 2011
IBM Global Business Services  September 2010 - January 2011
Validant   September 2009 - June 2010
Hays Pharma   March 2007 - August 2009

Skills
Technical Recruiting, Contract Recruitment, Recruiting

Education
Duke University
BA, Economics and Political Science

San Francisco State University
MBA, Management

Experience
TESARO  January 2015 - Present
Validant   August 2014 - January 2015
DKB Consulting   2009 - January 2015
Biogen Idec  July 2010 - July 2014
Millennium Pharmaceuticals  July 2009 - January 2010
Emergent BioDefense   December 2001 - January 2009
Emergent BioDefense Operations   December 2001 - January 2009
Emergent BioSolutions  December 2001 - January 2009
BioPort Corporation  December 2001 - February 2007
ALK-Abello  September 1998 - December 2001

Skills
CMC, Auditing, Training, Facilities Management, Regulatory Affairs, FDA, GMP, Regulatory Submissions, Validation, Biotechnology, CAPA, GLP, Pharmaceutical Industry, Biopharmaceuticals, Sop, Change Control, Technology Transfer, V&V, Lifesciences, Clinical Development, Vaccines, IND, Regulatory Requirements, Pharmaceutics, CRO, Drug Development, R&D, Quality System, Medical Devices, Quality Assurance, Clinical Trials, 21 CFR Part 11, Biologics, Purification, eCTD, NDA, HPLC, LIMS, Quality Control, Assay Development, Oncology, ISO 13485, Chromatography, Formulation, Analytical Chemistry, GxP, Drug Discovery, Aseptic Processing, GCP, Pharmacovigilance

Education
University of Michigan   1988 — 1990
MPH, Public Health - Toxicology

Michigan State University   1979 — 1981
BA, Chemistry

Experience
Underwriters Laboratories  January 2012 - Present
Validant   2011 - January 2012
Tegrant Corporation  November 2010 - May 2011
Sloan Valve Company  January 2010 - December 2010
Baxter Healthcare  2007 - 2009
Shure Inc.  November 2000 - March 2007
Underwriters Laboratories  1986 - 2000

Skills
ISO 14971, Product Development, Medical Device Product..., IEC 62304, Engineering Management, Software Development, Testing, Product Lifecycle..., Medical Devices, Engineering, Cross-functional Team..., Manufacturing, Quality System, Leadership, SPC, Strategy, Kaizen, Process Improvement, R&D, Program Management, Injection Molding, Continuous Improvement, Team Leadership, Project Management, Lean Manufacturing, Product Management, Management

Education
Illinois Institute of Technology   2014 — 2018
Master of Science (M.S.), Computer Science

Illinois Institute of Technology   1992 — 1997
Master of Science (M.S.), Electrical Engineering

University of Illinois at Urbana-Champaign   1982 — 1986
Bachelor of Science, Electrical Engineering

Experience
Validant   2013 - Present
The Quantic Group Ltd.  November 2011 - February 2013
Genzyme  2011 - 2013
The Quantic Group  2011 - 2013
Celgene Corporation  November 2007 - June 2011
Watson Pharmaceuticals  March 2003 - November 2007
Wyeth  1999 - 2003
Baxter International Inc.  1999 - 2003
Marsam Pharmaceuticals, Cherry Hill, NJ   1999 - 1999
Molecular Biosystems, Inc., San Diego, CA   1997 - 1998

Skills
Technology Transfer, Cleaning Validation, Project Management, GMP, GxP, Sop, 21 CFR Part 11, Validation, Computer System..., Aseptic Processing, GAMP, Biopharmaceuticals, Biotechnology, CAPA, LIMS, GLP, Lifesciences, Change Control, Process Validation, Remediation, V&V, Pharmaceutical Industry, Regulatory Requirements, SOP, Life Sciences, Quality Assurance, FDA

Education
Far Eastern University   1976 — 1979
Zoology

Far Eastern University   1976 — 1979

University of Santo Tomas   1974 — 1976
General

Saint Louis University (PH)   1970 — 1974

Saint Louis University (PH)   1970 — 1974

Experience
Sharp Corporation  February 2012 - Present
B2 Solutions LLC   February 2009 - Present
RLM Consulting   January 2002 - Present
USDM  2015 - 2015
Validant   2013 - 2013
Validant   2013 - 2013
Validant   2013 - 2013
Synthes  2011 - 2012
West Pharmaceutical Services  2011 - 2011
Morphotek, Inc.   2009 - 2009

Skills
Validation, Pharmaceutical Industry, FDA, GMP, Sop, Computer System..., Quality Assurance, Software Compliance

Education
computer learning center   1998 — 1999

Eastern Kentucky University   1977 — 1982

Fairleigh Dickinson University   1977 — 1982

Duquesne University   1978 — 1981

Drew University   1976 — 1980

The College of New Jersey   1976 — 1980

Rutgers University-New Brunswick   1975 — 1979

Ursinus College   1975 — 1978

Hammonton High School   1973 — 1977

Experience
Validant   November 2014 - Present
GE Healthcare  March 2007 - December 2013
Abraxis BioScience  November 2006 - March 2007
Abbott Laboratories  July 2004 - November 2006
Sara Lee  July 2001 - July 2004

Skills
CAPA, Medical Devices, FDA, Quality System, Pharmaceutical Industry, Quality Assurance, Regulatory Affairs, ISO 13485, Process Improvement, Validation

Education
Ilinois State

Keller Graduate School of Management of DeVry University   2004 — 2006
MBA & MHRM

Xavier University of Louisiana   1997 — 1999

Chicago State University
BS

Whitney M. Young Magnet HS

Experience
Validant   June 2012 - Present
Pharma Tech Industries  May 2011 - Present
Morton Grove Pharmaceuticals  November 2010 - May 2011
Validant   June 2010 - October 2010
ANI Pharmaceuticals, Inc.   2008 - 2009
Elan  2002 - 2007

Skills
Analytical Chemistry, Quality Assurance, GLP, GMP, Sop, FDA, Validation, Quality System, Change Control, 21 CFR Part 11, CAPA, Computer System..., V&V, GxP, Regulatory Affairs

Education
Maryville University of Saint Louis   1984 — 1988
B.S., Information Systems / Management

University of Missouri-Columbia

Experience
XenoPort, Inc.   September 2015 - Present
Validant   November 2013 - September 2015
Real Staffing  July 2013 - November 2013
Mosaic  June 2012 - October 2012
Boehringer Ingelheim (Formerly Amgen Fremont)   March 2011 - November 2011
Amgen  June 2005 - March 2011
Johnson & Johnson  October 2004 - March 2005
LICENSE INSTRUCTION SCHOOLS   March 2004 - October 2004
PACIFIC NATIONAL REALTORS   October 2002 - October 2004
FREMONT SCHOOL   September 2000 - March 2002

Skills
Presentation Coaching, Training Program..., Development of Training..., Performance Analysis, Learning Management, Training Delivery, Instructional Design, Instructor-led Training, GMP, Training, Quality Assurance, Sop, Employee Training, Software Documentation, Cross-functional Team..., E-Learning, FDA, Learning Management..., Management, Needs Analysis, Program Management, Quality System, SharePoint, Human Resources, Process Improvement, Strategy, Project Management, Pharmaceutical Industry, Change Control, Biotechnology, Validation, CAPA, Biopharmaceuticals, 21 CFR Part 11, SOP

Education
California State University-Sacramento   1999 — 2002
Masters of Arts, English

University of California, Davis   1991 — 1995
Bachelors of Arts, English

Experience
FDA  January 2014 - Present
Validant   November 2011 - February 2012
Dendreon  December 2010 - December 2011
CIBA VISION  May 2010 - December 2010
Biogen Idec  September 2007 - September 2009
Amgen  April 2005 - July 2007
Abbott Laboratories  2002 - 2005
Wyeth  2001 - 2002
Cardinal Health  1999 - 2001

Skills
Technology Transfer, Quality Management, Oracle SQL, cGMP, CAPA, GMP, SPC, FDA, Sop, V&V, Validation, Medical Devices, Quality Assurance, GxP, Pharmaceutics, Quality Auditing, Quality System, Contract Manufacturing, Quality Control, Biotechnology, Trackwise, 21 CFR Part 11, Lean Manufacturing, Cross-functional Team..., HPLC, Manufacturing, Aseptic Processing, IND, Microbiology, Continuous Improvement, Laboratory, Change Control, Calibration, GLP, Minitab, Regulatory Submissions, Pharmaceutical Industry, Software Documentation, SOP, TrackWise

Education
Alabama State University   1994 — 1997
M.S., Microbiology- Immunology

Medical College of Georgia School of Medicine   1989 — 1994
Studied toward MD, Medicine

Paine College   1985 — 1989
B.S., Biology-Chemistry

Harvard University   1987 — 1987
Studied undergraduate Neuroscience, Pre-Med

Experience
DynPort Vaccine Company LLC, A CSC Company  2014 - Present
Ascendia Pharmaceuticals LLC   2014 - Present
Consultant  2011 - Present
Piramal Critical Care  2012 - 2014
Validant   2011 - 2012
Celator Pharmaceuticals  November 2005 - September 2011
Chiron Corporation  January 2003 - November 2005
RCM Technologies  December 2002 - December 2003
Stryker  December 2000 - December 2002
Duramed Pharmaceuticals  December 1998 - December 2000

Skills
Biotechnology, CAPA, GLP, GMP, HPLC, Quality Assurance, Validation, V, Sop, Quality Control, Leadership, Pharmaceutical Industry, FDA, Technology Transfer, Medical Devices, SOP, Quality System

Education
Stevens Institute of Technology   1978 — 1986
Ph.D.

LIU Brooklyn   1974 — 1978
MS

City University of New York City College   1969 — 1973
BS

Experience
Leidos  October 2010 - Present
Validant   June 2010 - September 2010
Osiris Therapeutics  November 2008 - June 2009
Actavis  September 2006 - October 2008
Actavis (previously Alpharma)   September 2006 - October 2008
Actavis  October 2005 - November 2006

Skills
GMP, FDA, Quality System, Change Control, Sop, 21 CFR Part 11, LIMS, Quality Assurance, Pharmaceutical Industry, CAPA, Analytical Chemistry, Biotechnology, Computer System..., Document Management, GLP, HPLC, Laboratory, Lifesciences, Pharmaceutics, Quality Auditing, Quality Control, Quality Management, Regulatory Affairs, Root Cause Analysis

Education
Aquinas College   1997 — 2000
BS, Biology

Saint Joseph's University   1989 — 1993
BS, Psychology

Experience
Halyard Healthcare   October 2014 - Present
Validant   July 2014 - October 2014
CVC Consulting   September 2012 - June 2014
The Quantic Group  April 2011 - August 2012
Botanical Laboratories   December 2008 - April 2011
Leiner health Products  February 2008 - October 2008
Sandoz  April 2003 - January 2008
DSM Pharmaceuticals  1998 - 2003
Alpharma  1993 - 1998
Shering-Plough  1991 - 1993

Skills
Statistics, Agronomy, Cereal Chemistry, Compliance Management, Quality Engineering, Quality Assurance, Quality Auditing, Quality Systems, Quality System, Quality Control, Validation, FDA, Regulatory Affairs, Pharmaceutical Industry, Cleaning Validation, Change Control, 21 CFR Part 11, Sop, CAPA, V&V, GMP, Supplier Quality..., Project Management, Statistical Modeling

Education
North Dakota State University   1980 — 1984
Agonomy/Statistics

Pennsylvania State University-Erie Campus   1973 — 1980
BS, Biology, Genetics

Experience
PPD  June 2013 - Present
Validant   June 2010 - June 2013
Navigant Capital Advisors  June 2006 - June 2010
Jacobs Capital  January 2005 - April 2006
Broadbay Networks  August 1999 - April 2002

Skills
Valuation, Accounting, Financial Analysis, Financial Reporting, Financial Modeling, Business Strategy, Business Development, Investment Banking, Private Equity, Debt, Debt Restructuring, Mergers, Acquisitions, FDA, Mergers & Acquisitions, Due Diligence

Education
Emory University - Goizueta Business School
MBA, Finance and Accounting

The Johns Hopkins University
MS, Biotechnology

Vanderbilt University

The Westminster Schools

Experience
Pharma Tech Industries  June 2013 - April 2015
Validant   March 2013 - May 2013
Pall Corporation  July 2010 - January 2013
Boehringer Ingelheim  August 2009 - July 2010
Boehringer Ingelheim  July 2008 - July 2009
Boehringer Ingelheim  November 2007 - July 2008
Boehringer Ingelheim  January 2006 - November 2007
Merck  August 2003 - September 2005
Merck  August 1999 - August 2003
Merck  June 1993 - August 1999

Skills
Validation, Change Control, Quality System, Quality Assurance, GMP, CAPA, 21 CFR Part 11, FDA, Sop, Cleaning Validation, GxP, Pharmaceutical Industry, Trackwise, LIMS, GLP, Quality Auditing, FDA GMP, Vaccines, Pharmaceutics, Technology Transfer, cGMP practices, Deviation Management, Analytical Chemistry, Chromatography, Regulatory Affairs, Biopharmaceuticals, Contract Manufacturing, Deviations, Quality Management, HPLC, GAMP, ISO 13485, Root Cause Analysis, Quality Control, Regulatory Requirements, Auditing, ISO, Supplier Quality, Equipment Qualification, Raw Materials, cGMP manufacturing, Iso 9000, USP, Pharmaceutical..., Batch Release, NDA, Manufacturing Operations, Thrive in A Fast-paced..., Enjoy Challenges, Cross-functional Team...

Education
Georgia Institute of Technology   1987 — 1989
N/A, Analytical Chemistry

Indiana University of Pennsylvania   1984 — 1987
MS, Analytical Chemistry

St. Xavier's College   1980 — 1983
B.Sc., Chemistry

Experience
Stratus and Associates   April 2007 - Present
Validant   2013 - 2015
Validant   2013 - 2015
Abbott Medical Optics  July 2007 - October 2012
Syngenta  July 2004 - January 2007
Syngenta  June 1995 - July 2004
Syngenta  1992 - 1995
Quality Associates, Inc.   June 1986 - December 1991
Bayer CropScience  September 1984 - September 1986
Bowman Gray School of Medicine  1983 - 1984

Skills
Product Development, Project Management, Portfolio Management, Global Management, Document Management, Stage-Gate, Design Control, Cross-functional Team..., Biotechnology, R&D, Medical Devices, Market Development, GMP, Regulatory Affairs, Validation, GLP, FDA, Quality Assurance

Education
University of North Carolina at Greensboro   1989 — 1992
Master Science - Chemistry, Organic Chemistry, Pesticide Worker Exposure

Guilford College   1979 — 1983
Bachelor in Science, Chemistry, Math, and Geology

Chatham High School

Experience
Durata Therapeutics  May 2014 - Present
Alexion Pharmaceuticals  October 2012 - December 2013
Validant   October 2011 - October 2012
Novo Nordisk Inc.  January 2001 - November 2010
Pfizer Pharmaceuticals  August 1999 - December 2000
Aventis Behring (now CSL Behring)   November 1996 - August 1999
Cephalon (now Teva)   November 1994 - November 1996
Sanofi (Formerly Sterling)   1991 - 1995

Skills
21 CFR Part 11, FDA, GxP, Pharmaceutical Industry, Sop, GMP, Risk Management, Quality Systems Design, Compliance..., GCP, Quality Auditing, Quality Management, Aseptic Processing, CAPA, Biopharmaceuticals, V&V, Regulatory Requirements, Validation, Biotechnology, Quality System, Computer System..., Quality Control, Trackwise, Six Sigma, Quality Assurance, Change Control, Lifesciences, GAMP, GLP, Technology Transfer, Regulatory Affairs, Regulatory Submissions, ISO 13485, Pharmaceutics, Cleaning Validation, Clinical Trials, Medical Devices, Cross-functional Team..., R&D, Clinical Development, CRO, FDA GMP, Vaccines, Pharmacovigilance, Drug Development, SOP, Life Sciences, Process Improvement

Education
Villanova University
Master of Science, Information Science

Chestnut Hill College
BS, Biological Sciences

Experience
Gilead Sciences  November 2013 - Present
Pacific Medical Device   January 2010 - Present
Validant   August 2012 - October 2013
Medlogics DC   March 2005 - August 2010
Medlogics Device Corporation  March 2005 - August 2010
Medlogics Device Corporation  June 2005 - May 2010
Pacific Analytical Laboratory   March 2004 - July 2008
Cerus corporation  2001 - 2004
Cerus Corporation  July 2000 - January 2003
Bayer  January 2000 - May 2000

Skills
Biotechnology, GMP, Clinical Development, GLP, Regulatory Submissions, FDA, Drug Development, HPLC, Medical Devices, Regulatory Affairs, Analytical Chemistry, Lifesciences, Validation, Chromatography, Technology Transfer

Education
University of California, Davis   1985 — 1987
Post, Research

California State University-Fresno   1979 — 1982
MS, Chemistry

The National University   1970 — 1974
BS, Chemistry

Experience
Black Diamond Networks  April 2014 - June 2014
Black Diamond Networks  October 2013 - March 2014
Validant   July 2013 - October 2013
Black Diamond Networks  August 2012 - June 2013
Oxford International  May 2011 - July 2012
Innovations Consulting Group, LLC   February 2007 - March 2011
Maetrics, LLC  September 2005 - January 2007

Skills
Quality Assurance, Employee Training, Risk Management, FDA, ISO 13485, Quality System, Validation, Software Documentation, Sop, Team Building, Program Management, Manufacturing..., CAPA, Team Leadership, Quality Control, Cross-functional Team..., Medical Devices, Clinical Trials, Six Sigma, Quality Management, Process Simulation, Biotechnology, Process Improvement, Regulatory Affairs, Quality Auditing, Lifesciences, Lean Manufacturing, Iso 9000, GMP, FMEA, Testing, Document Management, Pharmaceutical Industry, Clinical Development, Management, Product Development, R&D, Root Cause Analysis, Manufacturing, ISO, Technology Transfer, Operational Excellence, Change Management, SPC, Product Launch, Business Process..., Value Stream Mapping, Kaizen, Training, Strategic Planning

Education
Northeastern University   2012 — 2016
Master of Science (M.S.), Regulatory Affairs for Drugs, Biologics and Medical Devices

Marian University   1998 — 2000
Bachelor of Science (B.S.), Biology and Chemistry

Experience
ONMedical   August 2015 - Present
QCS North America   June 2013 - June 2015
Validant   January 2013 - May 2013
Tunnell Consulting, Inc.   April 2012 - December 2012
Beckman Coulter  September 2006 - December 2011
Schering-Plough Research Institute  September 2001 - September 2006
The University of Iowa  August 1998 - September 2002
Schering-Plough Research Institute  August 1996 - August 1998

Skills
Lean Manufacturing..., Problem Solving, Manufacturing Operations, Quality Systems, cGMP Change Control..., 5S, Facility Operations, GMP, Process Improvement, Lean Manufacturing, Six Sigma, Change Control, Value Stream Mapping, Manufacturing, Kaizen, Industrial Engineering, Medical Devices, Toyota Production System, Continuous Improvement, Kanban, Validation, ISO, Quality System, Sop, Quality Control, FDA, Technology Transfer, V&V, ISO 13485, Root Cause Analysis, Software Documentation, DMAIC, Quality Auditing, Pharmaceutical Industry, Minitab, Testing, Design Control, SOP

Education
New Jersey Institute of Technology   1986 — 1992
IE, Production and Manufacturing

Teterboro School of Aeronautics   1988 — 1990
Aviation Technology A&P FAA, Aircraft Airframe and Power Plant Certification

Experience
Validant   March 2014 - Present
Johnson & Johnson - McNeil Consumer Healthcare  January 2012 - July 2013
Johnson & Johnson - Group of Consumer Companies  July 2010 - December 2011
Johnson & Johnson - Group of Consumer Companies  October 2008 - May 2010
Johnson & Johnson - Group of Consumer Companies  March 2007 - September 2008
Johnson & Johnson - Group of Consumer Companies  March 2006 - March 2007
Johnson & Johnson - Group of Consumer Companies  March 2002 - March 2006
Johnson & Johnson Group of Consumer Companies  November 1997 - March 2002
Johnson & Johnson - Group of Consumer Companies  November 1991 - May 1997
Johnson & Johnson - Group of Consumer Companies  April 1974 - May 1984

Skills
Operations Management, Change Management, Cross-functional Team..., Succession Planning, Strategic Planning, Sales Operations, Strategy, Process Improvement, Sales, Competitive Analysis, Supply Chain, Forecasting, Leadership, Procurement, Supply Chain Management

Education
Duquesne University
BA, English

Experience
Validant   January 2014 - Present
Rhino's Special Ears   2010 - Present
American Medical Systems  2006 - 2009
Microsulis   2006 - 2007
Microsulis   2005 - 2007
CW Bill Young Department of Defense Marrow Donor Program   January 1995 - January 2005
US Navy  1988 - 1998

Skills
Post market Clinical..., Medical Device and..., Lieutenant Commander US..., Critical Care Medicine, Published Author, Medical Devices, Healthcare, Surgery, Capital Equipment, Hospitals, Clinical Research, Cardiology, Training, Operating Room, Management, Surgeons, Nursing

Education
Jacksonville University   1993 — 1995
BSN, Nursing

Saint Anthony School of Nursing   1975 — 1978
Nursing, Nursing

Burlington Central High School   1972 — 1975
High School

Experience
Consulate General of Canada in Chicago   March 2014 - Present
College Track  September 2013 - March 2014
San Francisco Board of Supervisors  September 2013 - March 2014
California State Assembly  September 2013 - December 2013
YWCA Greater Charleston   August 2012 - August 2013
SF Restaurant   June 2003 - August 2012
Validant   November 2011 - March 2012
Campaign for San Francisco Mayor   June 2011 - November 2011
Common Sense Media  June 2011 - August 2011
Einstein Noah Restaurant Group, Inc.   June 2007 - August 2007

Skills
Non-profit Program..., Community Outreach, Cold Calling, Cultural Diversity, Editing, Fundraising, FDA, Program Management, Policy, Research, Recruiting, CRM, Leadership, Budgets, Event Planning, Public Speaking, Nonprofits, Social Media, Event Management, Policy Analysis

Education
McGill University
Bachelor of Arts & Science, Biomedical Sciences, Political Science, Canadian Ethnic and Racial Studies

National University of Singapore
Independent exchange, New Media

UC Berkeley
Independent exchange, Immigration Politics, Physics

Lowell High School

Experience
NSF  October 2014 - Present
Validant   March 2013 - December 2013
Novartis Consumer Health  January 2012 - October 2012
Sandoz, Austria   November 2011 - December 2011
Sandoz, B   August 2011 - November 2011
NNE Pharmaplan  June 2010 - May 2011
Bayer HealthCare  October 2004 - October 2009
Bayer HealthCare  July 2003 - September 2004
Bayer HealthCare  January 2002 - June 2003
Bayer HealthCare  January 1992 - December 2001

Skills
Change Control, GLP, Sop, Data Analysis, Biotechnology, Aseptic Processing, Quality Control, Auditing, Quality Management, Validation, Biopharmaceuticals, Technology Transfer, FDA, Inspection, Continuous Improvement, GMP, Software Documentation, Root Cause Analysis, CAPA, Laboratory, Quality System, Manufacturing, ISO 13485, Medical Devices, Assay Development, GAMP, Regulatory Requirements, Lifesciences, Management, Biochemistry, Quality Assurance, Testing, GCP, LIMS, Cross-functional Team..., Pharmacovigilance, Vaccines, ELISA, GxP, Regulatory Submissions, Six Sigma, Cleaning Validation, 21 CFR Part 11, Training, Pharmaceutical Industry, Quality Auditing, ISO, Internal Audit, Lean Manufacturing, Process Improvement

Education
Gujarat University   1971 — 1975
Bachelor of Science, Microbiology

Experience
Pharmaceutics International Inc. (Pii)   October 2012 - Present
Validant   January 2012 - November 2012
AAIPharma Services Corp.  2002 - 2012
DSM  2001 - 2002
Bausch & Lomb  1989 - 2001
Altana  1986 - 1989
E. R. Squibb and Sons   1978 - 1986
Becton Dickinson  1971 - 1978

Skills
Reviews, Quality Auditing, Regulatory Audits, Aseptic Processing, Validation, GMP, FDA, CAPA, Change Control, Quality System, V&V, GxP, 21 CFR Part 11, Quality Assurance, Manufacturing, Sop, Quality Control, GLP, Pharmaceutical Industry, Technology Transfer, Microbiology, SOP, Sterilization

Education
Seton Hall University
MS, Microbiology

Marist College
BA, Biology

Experience
Validant   May 2015 - Present
Validant   June 2014 - April 2015
Validant   2013 - June 2014
Aprecia Pharmaceuticals  January 2011 - June 2012
Hoffmann-La Roche Inc.  January 2000 - January 2011
Hoffmann-La Roche Inc.  June 1986 - January 2000
Roche Vitamins  June 1996 - August 1999

Skills
Microsoft Project, Microsoft Office, Project Management, Continuous Improvement, Budget, Troubleshooting, Operational Efficiency, Lean Manufacturing, Operational..., Manufacturing, MS Project, FDA, GMP, Quality Control, Leadership, Management, Pharmaceutical Industry, Sop, Pharmaceutics, Validation, CAPA, Technology Transfer, Regulatory Affairs, GLP, 21 CFR Part 11, LIMS, Change Control, Analytical Chemistry, Chromatography, HPLC, Formulation, Regulatory Submissions, Budgets

Education
Rutgers University   1992 — 1994
Master of Business Administration (MBA), Executive MBA

Fairleigh Dickinson University
Master of Science (MS), Chemistry

Experience
Sunovion  April 2015 - Present
Independant  January 2000 - Present
Synageva BioPharma Corp.  December 2013 - February 2015
Shire  June 2013 - December 2013
Validant   June 2012 - March 2013
Multiple  1991 - 2013
AMAG Pharmaceuticals  June 2011 - May 2012
the Quality System Solution   October 2009 - June 2011
Lonza Biologics  October 2010 - April 2011

Skills
GMP, Quality System, Quality Assurance, Lifesciences, Change Control, Auditing, Validation, Sop, Protocol, CAPA, 21 CFR Part 11, FDA, GxP

Education
Lesley University
BA, English

Experience
Pfizer  September 2015 - Present
Hospira  June 2013 - September 2015
Validant   February 2012 - September 2012
CorePharma LLC  March 2011 - October 2011
Sandoz  June 2009 - September 2010
Hospira  June 2004 - June 2006
Bayer  April 1997 - July 2001

Skills
Validation, V&V, Sop, Cleaning Validation, CAPA, FDA, 21 CFR Part 11, GxP, Biotechnology, Pharmaceutical Industry, Technology Transfer, Computer System..., Regulatory Affairs, Aseptic Processing, Pharmaceutics, Quality System, GLP, Deviations, Quality Assurance, Biopharmaceuticals, GAMP, Change Control, Manufacturing, Regulatory Requirements, LIMS, Quality Control, SOP development, ISO 13485, Quality Auditing, Regulatory Submissions, Medical Devices, FDA GMP, Calibration, Chromatography, cGMP practices, Lifesciences, Trackwise, Vaccines, Analytical Chemistry, Formulation, Sterilization, Drug Delivery, Microbiology, Pharmacovigilance, R&D, HPLC, Process Optimization, FMEA Risk Assessment, Internal & External..., APIs

Education
North Carolina State University   1992 — 1996
Bachelor of Science (BS), Biochemistry, 3.25

North Carolina State University   1992 — 1996
Bachelor of Science (B.S.), Zoology/Animal Biology, 3.25

Nash Community College   1990 — 1992
Associate of Arts and Sciences (A.A.S.), Associate of Science and Arts, 4.0

Experience
Validant   September 2013 - Present
Sandoz  June 2012 - July 2013
CIBA Vision  February 2011 - June 2012
Teva Pharmaceuticals  November 2005 - February 2011
Kiel Laboratories  February 2004 - November 2005
Southwest Research Institute  February 2003 - November 2003

Education
Auburn University
BACHELORS OF SCIENCE, Chemistry

Liberty University
MASTER'S, BUSINESS ADMINISTRATION; International Business

Experience
Validant   May 2014 - Present
St. Jude Medical  November 2012 - May 2014
UTSW Medical Center  November 2010 - October 2011
Parkland Health and Hospital Systems  August 2006 - November 2010
Katz Media Group  March 2004 - April 2005

Skills
MS Office, SmartDraw, Donovan Data Systems, PeopleSoft, Office Management, Human Resources, Management, Microsoft Excel, Time Management, Budgets, Microsoft Office, Data Entry, Payroll, SAP, Epic Systems, Customer Service, Software Documentation, PowerPoint

Education
University of North Texas   1998 — 2003
BBA, Business Administration and Management, General

Eastfield College   1996 — 2000
Associate Degree