Integrated Commissioning & Qualification, Corp.
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Integrated Commissioning & Qualification, Corp. Employees
Integrated Commissioning & Qualification, Corp. June 2012 - October 2012
Genzyme June 2011 - August 2011
Skills
Software Development, Java, C++, Mobile Applications, Databases, JavaScript, Objective-C, Microsoft Office, HTML, Efficiency, Word Processing, Embedded Systems, Programming, Computer Hardware, Highly motivated..., Matlab, Multisim, Observation, Business Strategy, PSoC, Accurate Data Entry
Education
University of New Hampshire 2009 — 2014
Bachelor's degree, Computer Engineering
Integrated Commissioning & Qualification, Corp. August 2014 - Present
Merck 2013 - 2014
Merck 2011 - 2013
Foundations Behavioral Health 2009 - 2010
Profact Proteomics 2009 - 2009
Bio/Data Corporation 2008 - 2009
Skills
Microbiology, PCR, Biochemistry, Biotechnology, Laboratory, HPLC, Sop, Vaccines, Pharmaceutical Industry, Quality Control, Formulation, GMP, Validation, Cell Biology, Medical Devices
Education
Delaware Valley University 2006 — 2009
Bachelor of Science (BS), Pre-Professional Biology
Intergrated Commissioning and Qualification December 2012 - March 2014
Integrated Commissioning & Qualification, Corp. December 2012 - March 2014
PRO Unlimited September 2010 - December 2012
Quality Personnel September 2009 - September 2010
INC August 2008 - September 2009
Veritude - Fidelity Investments September 2006 - November 2007
FedEx Express March 2003 - November 2007
Education Development Center, Inc January 1998 - July 2001
Skills
Outlook, Microsoft Excel, Leadership, PowerPoint, Microsoft Word, Salesforce.com, Logistics, Strategic Planning, Cross-functional Team..., Process Scheduler, Operations Management, Customer Service, Employee Relations, Microsoft Office, Human Resources, Gage Insite, Process Improvement, Software Documentation, Analysis, Therapeutic Massage, Team Building, Management, Research, Project Management, Training, Administrative..., Troubleshooting, Budgets, Sop, Marketing, Event Planning, GMP, Office Management, Recruiting, Healthcare
Education
Salter School-Fall River Campus 2012 — 2013
Licentiate degree, Massage Therapy/Therapeutic Massage
Mass Bay Community College 2009 — 2010
Medical Microbiology and Bacteriology
New Horizons Computer Learning Center 1999 — 2002
Certified Internet Webmaster Track, Databases
New England Institute of Technology 1993 — 1995
Associate of Science (AS), Medical/Clinical Assistant
King Philip Regional 1982 — 1986
High School Diploma, Business/Corporate Communications
Integrated Commissioning & Qualification, Corp. June 2014 - Present
Genzyme September 2012 - June 2014
Biogen Idec December 2004 - September 2011
Skills
21 CFR Part 11, Validation, CAPA, Change Control, GMP, Trackwise, GxP, LIMS, FDA, Quality Assurance, GLP, Quality System, Sop, TrackWise, Aseptic Processing, Biopharmaceuticals, SOP, Biotechnology
Education
University of Massachusetts Boston 1995 — 1999
Integrated Commissioning & Qualification, Corp. September 2012 - May 2013
URI EMS January 2009 - August 2012
CVS Caremark April 2006 - June 2012
Neuro-Rehabilitation Laboratory May 2010 - September 2010
URI Department of Engineering January 2010 - July 2010
Assistive Technology Laboratory May 2009 - July 2009
URI Biotechnology Laboratory September 2004 - June 2005
Skills
Matlab, C++, Pspice, Biotechnology, Medical Devices, Programming, Validation, Research, Windows, Microsoft Office, Customer Service
Education
Ross University School of Medicine 2013 — 2017
Doctor of Medicine (M.D.), MS3
University of Rhode Island 2007 — 2011
B.S., Biomedical Engineering
Integrated Commissioning & Qualification, Corp. August 2012 - Present
ULTRA Scientific November 2003 - August 2012
Vishay April 1995 - April 2003
Skills
Clean Rooms, HPLC, GC-MS, ICP-MS, Photolithography, Microsoft Office, Wet Chemistry, Wet Lab, Wet Chemical Etching, Microscopes, Autoclave, Analytical Chemistry, Inorganic Chemistry, AKTA Avant, AKTA Purifier, Spectrophotometry, Osmometer, Blood Gas Analyzer, Validation, Biotechnology, cGMP practices, LIMS, GMP, Project Management, Project Planning, CAPA, Biopharmaceuticals, FDA, Quality Control, 21 CFR Part 11, Technology Transfer, Pharmaceutical Industry
Education
Community College of Rhode Island 1995 — 1997
Coventry High School 1990 — 1994
High School Diploma, General Studies
Integrated Commissioning & Qualification, Corp. 2012 - May 2015
Hanger Prosthetics and Orthotics Inc. March 2011 - August 2011
Nunnery Orthotic and Prosthetic Technologies February 2010 - May 2010
Skills
FDA, Calibration, V&V, Software Documentation, Validation, GMP, Biomedical Engineering, Sop, Biotechnology
Education
University of Hartford 2015 — 2017
Master’s Degree, Prosthetics and Orthotics
University of Rhode Island 2007 — 2012
Bachelor of Science (BS), Biomedical Engineering
Integrated Commissioning & Qualification, Corp. August 2011 - Present
Genzyme sanofi 2012 - 2013
AMRI 2012 - 2012
AstraZeneca 2007 - 2011
Skills
Validation, 21 CFR Part 11, GMP, CAPA, HPLC, Lean Manufacturing, Cross-functional Team..., GLP, Quality Assurance, GxP, Change Control, Quality Auditing, LIMS, FDA, Regulatory Affairs, Sop, Process Simulation, Lifesciences, Biotechnology, Quality Control, GAMP, Pharmaceutical Industry, Process Engineering, Quality Management, Root Cause Analysis, Medical Devices, V&V, Manufacturing, Software Documentation, Computer System..., Quality System, Technology Transfer, ISO 13485, Pharmaceutics, Biopharmaceuticals, Six Sigma, Regulatory Submissions, Regulatory Requirements, Aseptic Processing, Cleaning Validation, Continuous Improvement, SOP
Education
Clark University
Computer Science
Barry-Wehmiller Design Group April 2013 - Present
PharmEng Technology October 2012 - April 2013
Integrated Commissioning & Qualification, Corp. December 2009 - November 2012
Stryker Biotech May 2008 - December 2009
Validation Technologies, Inc. January 2006 - May 2008
Wyeth BioPharma October 2000 - January 2006
Nashua Corp 1997 - 2000
Skills
Process Validation, Validation, cGMP, Biotechnology, GMP, Process Engineering, Metrology, Delta V, V&V, Biopharmaceuticals, Manufacturing, Commissioning, FDA, 21 CFR Part 11, Change Control, Pharmaceutical Industry, Computer System..., GAMP, GxP, Quality System, Sop, Quality Assurance, Troubleshooting, CAPA, Medical Devices, Software Documentation, Regulatory Affairs, ISO 13485, GLP, Process Simulation, LIMS, Calibration, Testing, Technology Transfer, Cleaning Validation, Engineering, Quality Auditing, Aseptic Processing, Root Cause Analysis, Regulatory Requirements, Quality Management, Lifesciences, HPLC, Pharmaceutics, PLC, Sterilization, Chromatography, Cell Culture, Regulatory Submissions, R&D
Education
Merrimack College 1992 — 1995
Electrical and Electronics Engineering
Integrated Commissioning & Qualification, Corp. November 2007 - Present
Amgen January 2003 - November 2007
Valsource Inc. August 1998 - January 2003
Massachusetts Biologics Laboratories 1997 - 1998
BASF Bioresearch Corporation August 1994 - August 1996
Repligen Corporation February 1993 - August 1994
Seragen Corporation May 1992 - February 1993
Sepracor Incorporated October 1990 - May 1992
United States Air Force June 1987 - June 1990
Skills
Project Management, Qualification, Commissioning, Program Management, 21 CFR Part 11, Biotechnology, Sop, Change Control, FDA, GMP, Pharmaceutical Industry, V&V, Quality System, CAPA, Biopharmaceuticals, Computer System..., Lifesciences, Medical Devices, Validation, Quality Assurance, Regulatory Submissions, Technology Transfer, Process Simulation, Quality Control, Manufacturing, GxP, Software Documentation, Cross-functional Team..., Regulatory Affairs, Pharmaceutics, Testing, ISO 13485, Quality Management, Process Engineering, Laboratory, Engineering, Regulatory Requirements, R&D, Quality Auditing, Commercialization, GLP, Vaccines, HPLC, Product Development, Contract Manufacturing, SOP, Equipment Qualification, Project Planning, Corporate Communications, Change Management
Education
Northeastern University 1996 — 2007
Bachelor of Science
Franklin Pierce University 1990 — 1993
Associate of Arts
Integrated Commissioning & Qualification, Corp. September 2014 - Present
Unicorr Packaging Group May 2011 - September 2014
CPI Corp. 2010 - 2011
Skills
AutoCAD, InDesign, Photoshop, Illustrator, Microsoft Office, Adobe Creative Suite, Advertising, Cross-functional Team..., Management, Microsoft Excel, PowerPoint, Project Management, Software Documentation, Training
Education
Salve Regina University 2006 — 2010
Photography
Integrated Commissioning & Qualification, Corp. April 2013 - Present
Shire Pharmaceuticals October 2001 - April 2013
Skills
GMP, Trackwise, Change Control, Sop, Biopharmaceuticals, Validation, CAPA, LIMS, Pharmaceutical Industry, 21 CFR Part 11, Aseptic Processing, FDA, Technology Transfer, Biotechnology, GxP, GLP, Computer System..., Aseptic Technique, V&V, Deviations, Quality System, Chromatography, Regulatory Affairs, Regulatory Requirements, Cleaning Validation, Drug Development, Regulatory Submissions, SOP
Education
University of Massachusetts Lowell 1995 — 1997
Mallinckrodt Pharmaceuticals October 2015 - Present
Universal Nutrients November 2014 - June 2015
MedImmune October 2013 - July 2014
Dr. Reddy's Laboratories February 2013 - September 2013
The Polmarc Group, LLC April 2012 - November 2012
Integrated Commissioning & Qualification, Corp. August 2011 - April 2012
The Polmarc Group, LLC April 2002 - July 2011
Regeneron Pharmaceuticals March 2011 - April 2011
PuraCap September 2010 - December 2010
GE Healthcare March 2010 - October 2010
Skills
Validation, GMP, Pharmaceutical Industry, Training, CAPA, Quality System..., Quality Assurance, Quality Systems..., Regulatory Affairs, Biotechnology, Clinical Development, GxP, FDA, Quality System, V&V, Manufacturing, 21 CFR Part 11, Pharmaceutics, Sop, Regulatory Requirements, Computer System..., SOP, Quality Auditing
Education
University of Texas at Austin 1980 — 1984
New Balance March 2014 - Present
New Balance December 2013 - March 2014
Jola Venture Inc. June 2010 - December 2013
Integrated Commissioning & Qualification, Corp. July 2012 - August 2012
Pollak June 2011 - January 2012
CR Bard June 2010 - December 2010
Johnson & Johnson August 2009 - January 2010
Skills
Pro Engineer, Design for Manufacturing, Design of Experiments, Machining, Matlab, Product Design, Medical Devices, CAD, Engineering, R&D, Engineering Management, Mechanical Engineering
Education
Northeastern University 2012 — 2013
Master of Science (MS), Engineering Management
Northeastern University 2007 — 2012
Bachelor of Science, Mechanical Engineering
Milton public
Integrated Commissioning & Qualification, Corp. July 2012 - Present
Amgen 2005 - 2009
Skills
Change Control, 21 CFR Part 11, Sop, Validation, Biopharmaceuticals, Computer System..., GMP, CIP, SIP, Risk Management, Risk Assessment, CAPA, Microsoft Word, Adobe Professional, Microsoft Office, Microsoft Excel, ISPE, ASTM 2500, plateau, GDP, Plateau
Education
New England Institute of Technology
Coastal Calibration Laboratories, Inc. June 2015 - Present
Genzyme, a sanofi company August 2014 - June 2015
Integrated Commissioning & Qualification, Corp. December 2012 - April 2014
Integrated Commissioning & Qualification, Corp. November 2013 - January 2014
Integrated Commissioning & Qualification, Corp. October 2013 - November 2013
Integrated Commissioning & Qualification, Corp. December 2012 - July 2013
Central Communications Systems December 2011 - November 2012
People Solutions July 2009 - January 2010
Columbia Tech October 2007 - July 2009
UMass Biologics May 2006 - August 2006
Skills
Calibration/Metrology..., Musician, Construction, Organization, Mechanics, Automotive, Communication, Sales, Manufacturing, Customer Service, Program Management, Microsoft Excel, Metrology, Microsoft Office, Quality Control, Calibration, Team Building, PowerPoint, Lean Manufacturing, Sop, Microsoft Word, Project Management, Electronics, Customer Satisfaction, Quality System, Quality Assurance, Troubleshooting, Continuous Improvement, ISO, Biotechnology, CAPA, Testing, Quality Auditing, GMP, Six Sigma, Root Cause Analysis, Change Control, Commissioning, Software Documentation, 21 CFR Part 11, V&V, SOP
Education
Assabet Valley Regional Technical School 1995 — 1998
Electronics, Certificate of IEP Completion Program
Westborough High 1989 — 1993
Diploma, General Studies
Integrated Commissioning & Qualification, Corp. September 2015 - Present
Genzyme May 2012 - September 2015
Genzyme August 2010 - May 2012
Alexion Pharmaceuticals March 2007 - August 2010
Skills
LIMS, Technology Transfer, Validation, Manufacturing, Filtration, Aseptic Technique, HPLC, V&V, CAPA, Sop, Biotechnology, Aseptic Processing, GMP, Change Control, Pharmaceutical Industry, Trackwise, FDA, Fermentation, 21 CFR Part 11, Biopharmaceuticals, Purification, Protein Purification, Lifesciences, Cell Culture, GLP, Cleaning Validation, Deviations, Chromatography, Computer System..., CIP, cGMP manufacturing, cGMP practices
Education
University of Rhode Island 2001 — 2006
Integrated Commissioning & Qualification, Corp. November 2014 - Present
Mangan Inc. Biopharm division September 2013 - September 2014
East Coast Validation Services LLC 2010 - 2013
East Coast Validation Services, LLC October 2005 - July 2010
Shire Human Genetic Therapies 2007 - 2008
Skills
GMP, Biotechnology, Validation, Sop, CAPA, Change Control, GLP, Biopharmaceuticals, Quality Assurance, GxP, Computer System..., 21 CFR Part 11, GAMP, Quality System, FDA, Pharmaceutical Industry, Life Sciences, V&V, Medical Devices, Regulatory Affairs, Aseptic Processing, SOP
Education
Great Bay Community College 2003 — 2004
Certificate, Biotechnology- Research and Manufacturing methods, Validation
University of New Hampshire 1993 — 1997
BS, Zoology
Integrated Commissioning & Qualification, Corp. February 2015 - Present
Eliassen Group July 2014 - August 2014
Xcellerex April 2008 - April 2014
Biogen Idec April 2001 - April 2008
Alpha Analytical Labs May 1998 - April 2001
Skills
Biopharmaceuticals, GMP, Sop, Validation, FDA, Biotechnology, Technology Transfer, Aseptic Processing, Purification, Aseptic Technique, Chromatography, Cell Culture, Fermentation, Contract Manufacturing, Filtration, Manufacturing, GLP, SOP
Education
Eastern Connecticut State University 1996 — 1998
Bachelor's Degree, Biology, General, 3.1
American International College 1994 — 1996
Biology
Integrated Commissioning & Qualification, Corp. October 2014 - Present
Integrated Commissioning & Qualification, Corp. August 2011 - October 2014
Lonza August 2010 - August 2011
Valsource November 2007 - July 2010
MannKind Corporation November 2007 - June 2009
Amgen November 2005 - November 2007
Skills
Validation
Education
Northeastern University 2000 — 2005
Chemical Engineering
BC High
DPS Engineering April 2015 - Present
Integrated Commissioning & Qualification, Corp. August 2011 - March 2015
US Army December 2005 - August 2011
General Technical Services December 2005 - August 2011
ValSource, LLC January 2000 - December 2005
AHA Consulting Engineers March 1998 - December 1999
Skills
FDA, Quality System, Quality Assurance, Systems Engineering, CAPA, Process Engineering, Commissioning, Testing, Quality Management, Quality Control, V&V, Sop, Medical Devices, Manufacturing, SOP, Biotechnology, GMP
Education
Northeastern University
Mechanical Engineering
Worcester Polytechnic Institute
Woburn High
IPS September 2015 - Present
Integrated Commissioning & Qualification, Corp. August 2012 - September 2015
BFS Pharma February 2011 - August 2012
Advanced Vision Research August 2005 - February 2011
Rob Huson Consulting February 2003 - August 2005
Stelex-The Validation Group April 2002 - February 2003
Stelex-The Validation Group December 2001 - April 2002
Stelex-The Validation Group January 2001 - December 2001
Akorn, Inc February 2000 - January 2001
Akorn, Inc January 1998 - February 2000
Skills
Validation, Medical Devices, Regulatory Affairs, Technology Transfer, Quality Assurance, Manufacturing, Business Strategy, Auditing, Contract Negotiation, Contract Manufacturing, Operations Management, Due Diligence, Research, Intellectual Property, Consulting, Sterilization, Cosmetics, FDA, GMP, Trademarks, Pharmaceutical Industry, 21 CFR Part 11, Sop, Change Control, Biotechnology, Quality System, CAPA, Lifesciences, Computer System..., Supplements, Quality Auditing, GxP, ISO 13485, Product Development, Pharmaceutics, Cross-functional Team..., Ophthalmics, Quality Management, Document Management, Biopharmaceuticals, R&D, Process Engineering, Commercialization, Project Management, Regulatory Requirements, GLP, Quality Control, LIMS, Software Documentation, SOP
Education
University of Illinois at Urbana-Champaign
Bachelor, Chemistry
Integrated Commissioning & Qualification, Corp. June 2011 - Present
Skills
Validation, 21 CFR Part 11, GMP, CAPA, LIMS, Commissioning, Biomedical Engineering, Matlab, Engineering, Aseptic Technique, cGMP, Process Validation, Chromatography, Downstream Processing, Upstream Processing, FMEA
Education
University of Rhode Island 2007 — 2011
Rhode Island
EDUCATIONBachelors of Science, Biomedical Engineering
University of Rhode Island
Bachelor of Science, Biomedical Engineering
Integrated Commissioning & Qualification, Corp. June 2014 - Present
Repligen Corporation May 2012 - May 2014
PBM Nutritionals July 2010 - May 2012
Ben & Jerry’s June 2009 - August 2009
PBM Nutritionals May 2008 - August 2008
PBM Nutritionals May 2007 - August 2007
Skills
HPLC, Chromatography, Chemical Engineering, Chemistry, Distillation, Quality Control, Engineering, Manufacturing, Laboratory, Organic Chemistry, Heat Exchangers, Factory
Education
Clarkson University 2006 — 2010
Bachelors of science, Chemical Engineering