Azzur Group

Industry: Company

Description

Founded: 2010 Subsidiaries: 3Seed Marketing, Design & Interactive,

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Azzur Group Employees

Employee
Years
Job
Industry
Matthew Romey Matthew Romey Orange County, California Area Details
Matthew Romey's Azzur Group Experience August 2014 - Present
Job Project Manager at Azzur Consulting
Industry Medical Devices
Experience
Azzur Group   August 2014 - Present
Consulting Services  June 2014 - October 2014
GluMetrics, Inc.   November 2011 - September 2013
Glumetrics, Inc.   August 2007 - November 2011
Glumetrics, Inc.   May 2005 - August 2007
Terumo Cardiovascular Systems  1999 - 2005
3M Health Care  1992 - 1999

Skills
Medical Devices, R&D, Cross-functional Team..., Design Control, Validation, FDA, Biomedical Engineering, Product Development, ISO 13485, CAPA, Quality System, V&V, Project Management, Strategic Planning, Statistics, Chemistry, ISO 14971, Process Improvement, Biomaterials, Polymers, GLP, GMP, Lifesciences, Sop, Clinical Development, Clinical Research, Clinical Trials, Six Sigma, Software Documentation, 21 CFR Part 11, Manufacturing, Quality Control, HPLC, GCP, CTMS, Start-ups, Problem Solving, Process Simulation, Commercialization, Biotechnology, Sensors, Regulatory Affairs, Quality Assurance, Design of Experiments, Analytical Chemistry, FDA GMP, Product Launch, Quality Systems, Process Development, Life Sciences

Education
University of California, Irvine - The Paul Merage School of Business   2011 — 2013
Master of Business Administration (M.B.A.), Health Care Executive, 3.87 GPA

University of California, Berkeley
B.S., Chemistry

American Society for Quality
Certified Six Sigma Black Belt Refresher Course

University of California, Irvine - Extension
Project Management

Joshua Ratta Joshua Ratta Greater Boston Area Details
Joshua Ratta's Azzur Group Experience November 2014 - Present
Job Validation Specialist for Azzur Group
Industry Pharmaceuticals
Experience
Azzur Group   November 2014 - Present
Amgen  2015 - 2015
Amgen  2015 - 2015
Lyophilization Services of New England  October 2011 - November 2014
OPK Biotech, LLC  March 2010 - October 2011

Skills
Biotechnology, Molecular Biology, PCR, Cell Culture, Microbiology, Biochemistry, Purification, DNA, ELISA, Western Blotting, HPLC, Genetics, GMP, SDS-PAGE, Chromatography, Immunology, Chemistry, SOP, Fermentation, Science, Protein Purification, cGMP, Diagnostics, Cell Biology

Education
Boston University   2014 — 2018
Bachelor's Degree, Clinical Laboratory Science/Medical Technology/Technologist

Middlesex Community College   2007 — 2012
Associate's degree, Biotechnology

Middlesex Community College   2007 — 2011
As, Biotechnology

Justin Kong Justin Kong Orange County, California Area Details
Justin Kong's Azzur Group Experience December 2012 - August 2014
Job Engineer
Industry Chemicals
Experience
Johnson & Johnson - via Axelon   August 2014 - Present
Azzur Group   December 2012 - August 2014
PSC Biotech  2012 - 2012

Skills
Microsoft Office, Excel, Word, Matlab, Validation, GMP, Software Documentation, Change Control, Troubleshooting, Engineering, Technical Writing, Quality Assurance, AutoCAD, Data Analysis, Medical Devices, FDA, CAPA, 21 CFR Part 11, Sop, Testing, Quality System, Biopharmaceuticals

Education
UC Berkeley   2008 — 2012
Bachelor of Science (B.Sc.), Chemical Engineering

UC Berkeley   2008 — 2012
Bachelor of Science (B.Sc.), Nuclear Engineering

Ken Klingaman Ken Klingaman Greater Los Angeles Area Details
Ken Klingaman's Azzur Group Experience November 2014 - Present
Job Consultant at Azzur Group
Industry Management Consulting
Experience
Azzur Group   November 2014 - Present
The Klingaman Group   April 2013 - January 2015
The Klingaman Group   September 2013 - June 2014
The Klingaman Group   February 2013 - December 2013
Amcor  January 2009 - February 2013
Permaswage  June 2008 - September 2008
City of Santa Ana  September 2006 - April 2008

Skills
Project Management, Solidworks, Lean Manufacturing, Management, Analysis, Supply Chain, Process Improvement, Manufacturing, AutoCAD, Procurement, Industrial Engineering, Microsoft Office, Continuous Improvement, Management Consulting, Business Strategy, Operations Management, 5S, Logistics, Warehousing, Six Sigma, Supply Chain..., Process Flow..., Process Engineering, Proposal Writing, Supply Chain Management, Cross-functional Team..., Procurement Contracts, Capital Projects, Asset Management, Documentation Practices, DMAIC, Engineering, Contract Negotiation, Facilities Management, Quality Management, Product Development, Root Cause Analysis, Project Planning, Value Stream Mapping, Process Scheduler, Kaizen, 21 CFR Part 11, Computerized Systems, CAPA, Change Control, Commissioning

Education
California State Polytechnic University-Pomona   2005 — 2009
Bachelor of Science, Industrial and Manufacturing Engineering

Caitlin Quigley Caitlin Quigley San Francisco Bay Area Details
Caitlin Quigley's Azzur Group Experience February 2013 - Present
Job Helping my clients go from Discovery to Delivery™
Industry Pharmaceuticals
Experience
Azzur Group   February 2013 - Present
MedImmune  February 2013 - Present
Azzur Group   December 2011 - February 2012
Johnson & Johnson  January 2011 - December 2011
IPS  September 2007 - December 2011
Integrated Project Services  September 2007 - December 2011
Shire HGT  2010 - 2010

Skills
GAMP, Computer System..., Cleaning Validation, V&V, 21 CFR Part 11, GxP, Validation, Change Control, GMP, Commissioning, Sop, Quality Auditing, Quality Assurance, Process Engineering, CAPA, Biopharmaceuticals, GLP, Aseptic Processing, LIMS, FDA, SOP

Education
Rosemont College   2004 — 2007
Bachelor's degree, Biochemistry

Bryn Mawr College   2000 — 2003

Joycelin Luc Joycelin Luc Greater Los Angeles Area Details
Joycelin Luc's Azzur Group Experience February 2015 - Present
Job Engineer I at Azzur Group
Industry Medical Devices
Experience
Azzur Group   February 2015 - Present
Azzur Group   December 2014 - February 2015
Adagio Medical Inc.  January 2014 - December 2014
Teco Diagnostics  June 2013 - January 2014
The Scripps Research Institute  June 2012 - September 2012
Sanford-Burnham Medical Research Institute  June 2009 - August 2009

Skills
Solidworks, R&D, Transfection, Laboratory, Plasmid Isolation, Phage Display, Cell, Validation, Western Blotting, Quality Control, Microsoft Excel, Microsoft Office, Microsoft Word, FDA GMP

Education
University of California, Irvine   2010 — 2014
Bachelor of Science (B.S.), Biomedical Engineering

Torrey Pines High School   2006 — 2010
High school diploma

Evangelos Kustubardis Evangelos Kustubardis Greater Boston Area Details
Evangelos Kustubardis's Azzur Group Experience June 2015 - Present
Job Engineer at Azzur Group
Industry Biotechnology
Experience
Azzur Group   June 2015 - Present
Zimmer  October 2014 - June 2015
Hyde Engineering + Consulting  November 2013 - August 2014
Stevens Pharmaceutical Research Center  August 2012 - May 2013
Stevens Institute of Technology  May 2010 - May 2011

Skills
Titrations, Spectrofluorometry, Polarimetry, Preparing Solutions, Gas Chromatography, Fourier Transform..., Atomic Absorption..., Microinjection of Cells, Agarose Gel..., PCR, HPLC, Matlab, Minitab, M-Files, Titration, Pharmaceutical Industry, Laboratory, Protein Chemistry, Antibodies, Cleaning Validation, Recruiters, FTIR, Quality Control, Formulation, GLP, Design of Experiments, UV/Vis, Chromatography, GMP, TOC, Sop, Gage R&R, FMEA, Process Capability, Risk Management, GAMP, Atomic Absorption, Validation, SOP, FDA

Education
Stevens Institute of Technology   2011 — 2013
Master of Science (M.S.), Pharmaceutical Manufacturing

Stevens Institute of Technology   2009 — 2013
Bachelor of Science (B.S.), Chemical Biology

Angela Browne Angela Browne Seattle, Washington Details
Angela Browne's Azzur Group Experience June 2013 - December 2014
Job SR Lead Client Relationship Mananger
Industry Information Technology and Services
Experience
Azzur Group   June 2013 - December 2014
Cody Laboratories, Inc.   September 2012 - February 2013
Self-Employed  March 2012 - May 2012
Self Employed  May 2011 - August 2011
Dendreon  July 2009 - April 2011
Dendreon  August 2008 - June 2009
Diligere Consortium, Inc.   April 2000 - December 2007
KMI/PAREXEL, Inc.   1991 - 1993

Skills
21 CFR Part 11, Pharmaceutical Industry, Computer System..., Validation, FDA, Quality Assurance, CSV, Regulatory Requirements, Change Control, Software Documentation, Lifesciences, CAPA, GxP, GCP, Biotechnology, GLP, GAMP, GMP, Sop, Quality System, V&V, ISO 13485, LIMS, Biopharmaceuticals, Quality Auditing, Quality Control, Regulatory Affairs, Document Management, Technology Transfer, Aseptic Processing, Cross-functional Team..., ISO, Pharmaceutics, Cleaning Validation, Process Simulation

Education
Colorado School of Mines   1991 — 1992
Engineering, General Engineering with Specialty in Chemistry

Delaine Pedevill Delaine Pedevill Greater Los Angeles Area Details
Delaine Pedevill's Azzur Group Experience August 2014 - November 2014
Job Human Resources Specialist at Acosta Sales & Marketing
Industry Consumer Services
Experience
Acosta Sales & Marketing  September 2015 - Present
Professional Human Resources Consultant   December 2014 - June 2015
Azzur Group   August 2014 - November 2014
PSC Biotech  April 2013 - July 2014
Gilead Sciences  January 2005 - February 2008
United Stationers  November 2003 - December 2005
ACCO Brands  July 1998 - February 2000
Avery Dennison Label and Packaging Materials  January 1989 - January 1999

Skills
Team Leadership, Organization, HR Policies, Recruitment, Union Avoidance, Coaching, Employee Relations, Recruiting, Human Resources, HR Software, Employee Benefits, Policy, Leadership, Interviews, Onboarding, Succession Planning, Hiring, Performance Management, Personnel Management, Talent Management

Education
University of Phoenix
Bachelor of Science (BS), Business Administration and Management, General

University of Phoenix
Bachelor of Science (B.S.), Business Administration and Management, General

Raymond Terrell Raymond Terrell Greater Boston Area Details
Raymond Terrell's Azzur Group Experience July 2013 - Present
Job Senior Engineer at Azzur Group
Industry Pharmaceuticals
Experience
Azzur Group   July 2013 - Present
OPK Biotech LLC  June 2010 - June 2013
Crosspoint Engineering  September 2008 - June 2010
Biopure  1994 - 1998

Skills
Validation, Engineering, Cross-functional Team..., Automation, Biotechnology, Risk Management, Control Systems Design, Cleaning Validation, Risk Assessment, GMP, FDA, CAPA, V&V, Quality System, Change Control, Computer System..., 21 CFR Part 11, Pharmaceutical Industry

Education
University of New Hampshire

David Dabbs David Dabbs San Antonio, Texas Area Details
David Dabbs's Azzur Group Experience April 2014 - November 2014
Job Senior Validation Consultant at Azzur Group
Industry Pharmaceuticals
Experience
Quality BioResources   April 2014 - Present
US Army  May 1999 - Present
Azzur Group   April 2014 - November 2014
Center for Disease Detection  April 2012 - March 2014
QTC - A Lockheed Martin Company  September 2011 - April 2012
Talecris  August 2006 - March 2011
Stough Enterprises/PlasmaCare   May 2002 - August 2006
SAIC  January 2000 - January 2002

Skills
Quality Assurance, GMP, FDA, Process Improvement, Validation, Operations Management, Quality Auditing, Auditing, Biotechnology, CAPA, Quality Management, Root Cause Analysis, Continuous Improvement, cGMP, Compliance, Quality Systems, Document Management, TQM, SOP, Documentation, Lean Manufacturing, Life Sciences, Inspection, Process Development, Manufacturing, Problem Solving, Technical Writing, Quality System, Sop, Cross-functional Team..., Regulatory Affairs, Pharmaceutical Industry, Management, Medical Devices, Software Documentation, Process Simulation, Quality Control, Training, Leadership, Data Analysis, 21 CFR Part 11, Clinical Trials, Microbiology, Change Control, Project Management, Lifesciences

Education
Kaplan University-Davenport Campus   2014 — 2016
Master’s Degree, Homeland Security and Emergency Management

Michigan State University   1993 — 1998
Bachelors of Science, Microbiology

United States Army Reserve

Erik Zotter Erik Zotter Allentown, Pennsylvania Area Details
Erik Zotter's Azzur Group Experience April 2015 - Present
Job Principal at Azzur Consulting
Industry Pharmaceuticals
Experience
Azzur Group   April 2015 - Present
Azzur Group   October 2014 - March 2015
Azzur Group LLC   June 2012 - September 2014
Azzur Group   May 2009 - May 2012
Azzur Group   June 2007 - May 2009
Micro-Clean, Inc.   April 2002 - June 2007
Lucent Technologies (Agere Systems)   January 1998 - March 2002

Skills
GMP, ISO, Commissioning, Organization, European Union, FDA, Change Control, Validation, Quality Assurance, Project Planning, Troubleshooting, Sop, CAPA, Technology Transfer, Pharmaceutical Industry, Biotechnology, 21 CFR Part 11, Process Simulation, Testing, Six Sigma, Software Documentation, Quality System, Medical Devices, GxP, Computer System..., Cross-functional Team..., Manufacturing, Quality Control, GAMP, Quality Management, Management, GLP, Regulatory Affairs, Process Engineering, Root Cause Analysis, Quality Auditing, Regulatory Requirements, Calibration, Document Management, ISO 13485, SOP

Education
Cornell University   2014 — 2016
Executive Leadership

Lincoln Technical Institute-Allentown   1996 — 1998
Associate of Arts and Sciences (A.A.S.), Electrical and Electronics Engineering

Brittany Keegan Brittany Keegan Orange County, California Area Details
Brittany Keegan's Azzur Group Experience May 2015 - Present
Job Office Manager at Azzur Group
Industry Marketing and Advertising
Experience
Azzur Group   May 2015 - Present
INNOCEAN USA  December 2014 - April 2015
Power Training Institute   August 2014 - December 2014
American Cancer Society  May 2013 - August 2014

Skills
Microsoft Office 2008..., Microsoft Office Xp, PowerPoint, Microsoft Excel, Time Management, Data Entry, Customer Service, Sales, Telephone Skills, French, Food, Bookkeeping, Filing, Wine, Outlook, Administrative..., Critical Thinking, Facebook, Social Networking, Event Planning, Microsoft Word, Office Management, Social Media, Teamwork, Community Outreach, Recruiting, Event Management, Fundraising, Microsoft Office

Education
University of California, Santa Barbara
Bachelor's degree

Doug Shaw CISA, CRISC Doug Shaw CISA, CRISC Annapolis, Maryland Details
Doug Shaw CISA, CRISC's Azzur Group Experience January 2015 - Present
Job Director of IT & CSV Consulting at Azzur Group
Industry Medical Devices
Experience
Azzur Group   January 2015 - Present
cGMP Validation LLC  March 2007 - January 2015
Actavis  2002 - 2007
Genentech  1999 - June 2002
Bayer  1996 - 1998
Calypte Biomedical  1995 - 1996
Biowhittaker Inc.  1992 - 1995

Skills
21 CFR Part 11, Computer System..., Validation, GMP, CAPA, ISO 13485, Medical Devices, LIMS, ISO 14971, FDA, Software Quality..., Document Management, Software Documentation, Laboratory Automation, Cloud Computing, Risk Management, Risk Assessment, HIPAA, SAP, Software Project..., MS Project, Regression Testing, ERP, Software Engineering, Data Security, SaaS, System Testing, Computer Security, Risk Mitigation, IT Auditing, Healthcare IT, IT Governance, IT Outsourcing, Life Sciences, Software Design, Compliance Audits, Software Development..., 21CFR Part 820, 21CFR Part 210/ 211, ISO 62304, HIPAA Security Rule, Data Privacy, Laboratory Experience, Healthcare Compliance, cGMP, Pharmaceuticals, SOP/ Policy Development, Integration Testing, Quality Systems, V&V

Education
Hood College   1993 — 2000
MS, Biology

Radford University   1987 — 1991
BS, Biology, Chemistry

Nathaniel Preston Houck Nathaniel Preston Houck Raleigh-Durham, North Carolina Area Details
Nathaniel Preston Houck's Azzur Group Experience June 2015 - Present
Job Validation Engineer I Azzur Group
Industry Pharmaceuticals
Experience
Azzur Group   June 2015 - Present
Fujifilm Diosynth Biotechnologies  May 2014 - June 2015
Biomanufacturing Training and Education Center   January 2013 - May 2014
Novartis Vaccines and Diagnostics  May 2013 - August 2013
Mamtek U.S.   May 2011 - August 2011
North Carolina State University  August 2010 - May 2011
Thar Pharmaceuticals   June 2009 - August 2009

Skills
Aseptic Technique, Chemistry, Process Engineering, Filtration, Biofuels, DNA, Spectroscopy, Protein Purification, Purification, Laboratory, Media Prep, Autoclaving, Autoclave, Buffer Prep, Ultracentrifugation, Tangential flow..., Bio-Rad TC20 cell..., Sartorius Wave..., Vi-CELL, Akta Avant..., Ultrafiltration, JMP, Unicorn, Minitab

Education
North Carolina State University
Bachelor's Degree, Biological Engineering Concentrating in Bioprocessing, Minor: Biomanufacturing, 3.12

Central Catholic High School   2005 — 2009
High School, 4.0

Ryan Bogosian Ryan Bogosian Greater Boston Area Details
Ryan Bogosian's Azzur Group Experience October 2014 - Present
Job Consultant at Azzur Group
Industry Chemicals
Experience
Azzur Group   October 2014 - Present
AccuRounds   August 2014 - October 2014
Pfizer  June 2013 - August 2013

Skills
Chemical Engineering, Microsoft Office, Superpro Designer, Aspen Custom Modeler, Microsoft Visio, Adobe Creative Suite, EconExpert, Matlab, IR spectroscopy, Distillation, Adsorption, Liquid-liquid Extraction, Leadership, Microsoft Word, GMP

Education
University of New Hampshire   2010 — 2014
Bachelor of Science, Chemical Engineering

Canton High School   2006 — 2010

Max Lewis Max Lewis Greater Philadelphia Area Details
Max Lewis's Azzur Group Experience June 2013 - October 2014
Job Project Engineer at IPSIntegrated Project Services, Inc.
Industry Construction
Experience
IPS-Integrated Project Services, Inc.   November 2014 - Present
Azzur Group   June 2013 - October 2014
Integrated Project Services  September 2008 - June 2013

Skills
Project Engineering, Construction Management, Construction, Primavera P6, Project Estimation, Commissioning, Microsoft Office 2007, AutoCAD, Engineering, MEP, CPM Scheduling

Education
Drexel University   2007 — 2013
Bachelor's degree, Construction Management

Devin Morse Devin Morse Washington D.C. Metro Area Details
Devin Morse's Azzur Group Experience September 2015 - Present
Job Validation Engineer I at Azzur Group
Industry Pharmaceuticals
Experience
Azzur Group   September 2015 - Present
Azzur Group   April 2014 - September 2014
Chemtura  April 2013 - September 2013

Skills
Chemistry, GMP, Time Management, Validation, GLP, Computer System..., Microsoft Office, PowerPoint, Microsoft Word, Microsoft Excel, Public Speaking

Education
Drexel University   2012 — 2015
Bachelor's degree, Chemistry

Drew University   2010 — 2012
Chemistry, 3.3

Mark P. O'Donnell Mark P. O'Donnell Greater Philadelphia Area Details
Mark P. O'Donnell's Azzur Group Experience 2010 - 2011
Job Principal at Peak Performance Global Services, LLC (Career Agent & Recruiter)
Industry Pharmaceuticals
Experience
Peak Performance Global Services, LLC   January 2014 - Present
PharmEng Technology  January 2012 - January 2014
Biogen Idec  2010 - 2011
Azzur Group   2010 - 2011
Sanofi Pasteur  2006 - 2011
Jacobs Engineering  2003 - 2005
cGMP Validation LLC  2000 - 2003
Merck  1994 - 2002
Raytheon Engineers  1990 - 1998
United States Air Force  1976 - 1982

Skills
Business Development, Project Management, Team Building, Computer System..., Change Control, V&V, 21 CFR Part 11, Validation, GxP, CAPA, FDA, GMP, Sop, Biopharmaceuticals, Pharmaceutical Industry, Quality Management, Biotechnology, GAMP, Quality System, Management, Vaccines, Manufacturing, Commissioning, Technology Transfer, Aseptic Processing, Six Sigma, GLP, Industrial Engineering, Regulatory Affairs, Project Engineering, Root Cause Analysis, Medical Devices, Quality Assurance, Quality Control, Cleaning Validation, ISO 13485, Engineering, Strategy, Pharmaceutics, LIMS, Process Simulation, Regulatory Requirements, Lifesciences, Regulatory Submissions, Quality Auditing, Process Engineering, R&D, Drug Development, Document Management, People Skills

Education
Lehigh County Community College   1978 — 1982
Business Management

Troy State University   1977 — 1978
Business Management

Jonathan B. Smith Jonathan B. Smith New York, New York Details
Jonathan B. Smith's Azzur Group Experience September 2015 - Present
Job Author of Optimize for Growth & Certified EOS Implementer
Industry Professional Training & Coaching
Experience
ChiefOptimizer   September 2015 - Present
Azzur Group   September 2015 - Present
ChiefOptimizer   January 2011 - Present
Wave Dispersion Technologies, Inc.   January 2012 - Present
InnoviMobile   April 2015 - Present
RideScout (Sold to Daimler)   September 2013 - September 2014
Wave Disperson Technologies, Inc.   January 2005 - December 2011

Education
Wesleyan University
Bachelor of Arts (BA)

University of Hartford
Master of Science (MS)

Michigan State University
Certificate

Alex Sirois Alex Sirois Greater Boston Area Details
Alex Sirois's Azzur Group Experience October 2014 - August 2015
Job Graduate Student at Northwestern University
Industry Biotechnology
Experience
Northwestern University  September 2015 - Present
Azzur Group   October 2014 - August 2015
University of Massachusetts Lowell  July 2014 - September 2014
Analog Devices  January 2011 - January 2014

Skills
Microsoft Office, Process Validation, Chemical Vapor..., Photolithography, VBA, Matlab, Polymath, Minitab, cGMP manufacturing, CMMS, Nanomaterials, Process Engineering

Education
University of Massachusetts Lowell   2010 — 2014
Bachelor's Degree, Chemical Engineering

Emily Nelson Emily Nelson San Diego, California Details
Emily Nelson's Azzur Group Experience November 2014 - Present
Job Senior Engineer at Azzur Group
Industry Biotechnology
Experience
Azzur Group   November 2014 - Present
BioSPEQ, Inc, an Azzur Group Company   March 2014 - November 2014
BioSPEQ  October 2013 - March 2014
BioSPEQ  November 2012 - September 2013
Acceleron Pharma  January 2011 - August 2011
Nano-Terra, LLC  January 2010 - June 2010
Procter & Gamble  January 2009 - June 2009
Unilever  June 2008 - August 2008

Skills
Aseptic Technique, HPLC, UV/Vis, Cell Culture, Biotechnology, Chemical Engineering, Osmometer, Nanodrop, Particle Size, Aspen Plus, Fluent, Product Design, Process Engineering, Nanoparticles, Validation, Quality Assurance, GMP, Analytical Chemistry, Laboratory, Quality System

Education
Northeastern University   2007 — 2012
Bachelor of Science (BS), Chemical Engineering

Laura Hua Laura Hua Greater Los Angeles Area Details
Laura Hua's Azzur Group Experience March 2015 - Present
Job Engineer I at Azzur Group
Industry Pharmaceuticals
Experience
Azzur Group   March 2015 - Present
Baxter BioScience  June 2014 - March 2015
UCLA Department of Chemical Engineering, Yi Tang   June 2013 - June 2014
UCLA Department of Neurology, Daniel Geschwind   August 2012 - June 2013

Skills
Matlab, Microsoft Excel, Bacterial Transformation, Bacterial Cell Culture, Gel Electrophoresis, SDS-PAGE, Microsoft Word, PowerPoint, C++, Pro II, Microsoft Visio, Aseptic Gowning, PCR, Protein Expression, Column Chromatography, UV/Vis, GxP, Simulink, Chemical Engineering

Education
University of California, Los Angeles   2010 — 2014
BS, Chemical and Biomolecular Engineering

Mark B. Davenport Mark B. Davenport Costa Mesa, California Details
Mark B. Davenport's Azzur Group Experience April 2015 - July 2015
Job Sustaining Mechanical Engineer at BIOLASE, Inc.
Industry Mechanical or Industrial Engineering
Experience
BIOLASE, Inc.   July 2015 - Present
Azzur Group   April 2015 - July 2015
Cla-Val  May 2014 - April 2015
Alcon, a Novartis company  May 2011 - September 2013
UC Irvine  March 2013 - June 2013
UC Irvine  September 2012 - January 2013
California Baptist University  August 2009 - May 2011
California Baptist University  September 2008 - May 2009

Skills
Mechanical Engineering, Solidworks, Matlab, Engineering, CAD, Pro Engineer, Finite Element Analysis, Inventor, R&D, Medical Devices, Surgical Instruments, Biomedical Engineering, Design for Manufacturing, Manufacturing, Heat Transfer, Thermodynamics, AutoCAD, Labview, Machine Design, Machining, GD&T, Design of Experiments, Biotechnology, Microsoft Office, Microsoft Excel, Mathematica, ISO 13485, FDA, Mechanism Generator, LabVIEW, SolidWorks, Geometric Dimensioning

Education
University of California, Irvine   2012 — 2014
Master of Science (MSME), Mechanical Engineering

California Baptist University   2007 — 2012
Bachelor of Science (BSME), Mechanical Engineering

Bijan Shiravi Bijan Shiravi Orange County, California Area Details
Bijan Shiravi's Azzur Group Experience July 2015 - Present
Job Engineer II at Azzur Group
Industry Pharmaceuticals
Experience
Azzur Group   July 2015 - Present
Triton Engineering Student Council  April 2014 - Present
UC San Diego  May 2014 - June 2015
UC San Diego Nanoengineering Lab   February 2013 - May 2014
La Jolla Bioengineering Institute  September 2013 - December 2013
Lone Star Steakhouse  September 2010 - September 2012
Law Offices of Lee R Goldberg   October 2010 - May 2011
UC Irvine Neurobiology Research Lab   June 2009 - August 2009

Skills
Nanotechnology, Nanofabrication, Research, Customer Service, Microsoft Word, Public Speaking, Matlab, Physics, Nanoparticles, Leadership, Engineering, Project Management, AFM, Solar Cells, Organic Solar Cells, Spin Coating, Peer Tutoring, Photovoltaics, Semiconductors, Organic Semiconductors, Microsoft Office, Microsoft Excel, Characterization, Data Analysis, PowerPoint

Education
University of California, San Diego   2012 — 2015
Bachelor of Science (B.S.), Nanoengineering, 3.68

Orange Coast College   2010 — 2012
Associate of Science (A.S.), Engineering, 3.72

Aliso Niguel High School   2006 — 2010
High School Diploma, 4.01

St. Georges

St. Georges

Lute Yang Lute Yang San Francisco Bay Area Details
Lute Yang's Azzur Group Experience September 2014 - Present
Job Engineer I at Azzur Group
Industry Biotechnology
Experience
Azzur Group   September 2014 - Present
Genentech  November 2013 - August 2014
High Throughput Laboratory at Northwestern University   January 2011 - June 2013
Project on Children's Thinking at Northwestern University   September 2009 - January 2011

Skills
Matlab, Biomedical Engineering, Data Analysis, Mandarin, Access, PowerPoint, Minitab, Microsoft Excel, Microsoft Word, Statistics, Mathematica, Research, Cell Culture, Solidworks, PCR, Experimental Design, CAD, FEM analysis, FMEA, cGMP practices, cGMP manufacturing, Bioprocessing, Quality Assurance, Quality Control, Medical Devices, 5S, Manufacturing, Lean Manufacturing, FDA

Education
Northwestern University   2009 — 2013
Bachelor of Science, Biomedical Engineering

Brad Shives Brad Shives Baltimore, Maryland Area Details
Brad Shives's Azzur Group Experience March 2013 - January 2014
Job Project Manager at BarryWehmiller Design Group
Industry Biotechnology
Experience
Barry-Wehmiller Design Group  February 2014 - Present
Azzur Group   March 2013 - January 2014
Brad Shives Consulting   November 2011 - March 2013
Lonza  March 2008 - November 2011
BLS Contracting   June 2001 - March 2008
Huntzberry Brothers   March 2006 - October 2007
Sytel, Inc  1996 - 2002
US Army  1991 - 1991
US Army  1991 - 1991

Skills
Biotechnology, Lifesciences, Cell Culture, Microsoft Office, Microsoft Excel, Pharmaceutical Industry, Project Management, Strategic Planning, PowerPoint, Quality Assurance, Management, Leadership, Validation, Process Improvement, Contract Management, Team Building, Business Development, Biopharmaceuticals, Sop, FDA, Change Control, 21 CFR Part 11, Quality Control, Computer System..., GxP

Education
Frostburg State University   1988 — 1991
Bachelor of Science (BS), Health and Physical Education/Fitness

Lonza
Greenbelt - Lean Six Sigma

Brad Miscowski Brad Miscowski Greater Boston Area Details
Brad Miscowski's Azzur Group Experience March 2014 - Present
Job Engineer II
Industry Pharmaceuticals
Experience
Azzur Group   March 2014 - Present
OPK Biotech, LLC  November 2011 - December 2013
Lantheus Medical Imaging  January 2010 - November 2011

Skills
AutoCAD, PIDs, PFD, cGMP practices, Process Engineering, Chemical Engineering, Radiation Safety, Validation, GMP, CAPA, FDA, 21 CFR Part 11, Sop, Change Control, Teamwork, Biopharmaceuticals, Purification, Chromatography, HPLC, Aseptic Processing, Cleaning Validation, Process Simulation, Biotechnology, V&V, Technology Transfer, GxP

Education
University of New Hampshire   2005 — 2009
B.S., Chemical Engineering

Boston Architectural College
AutoCAD I-2D

Richard Lambke Richard Lambke Baltimore, Maryland Area Details
Richard Lambke's Azzur Group Experience October 2013 - June 2014
Job Quality Manager at Integrity Consulting
Industry Biotechnology
Experience
Integrity Consulting  January 2015 - Present
Enhanced Compliance Inc.   August 2014 - December 2014
Azzur Group   October 2013 - June 2014
MedImmune  January 2011 - September 2013
Centocor  July 2010 - December 2010
Model Metrics  April 2010 - July 2010
Eisai  August 2008 - May 2010
Par Pharmaceutical  January 2008 - July 2008
Bristol-Myers Squibb  August 2007 - December 2007
GE Healthcare  April 2007 - August 2007

Skills
Software Quality..., Computer System..., 21 CFR Part 11, FDA, GxP, Change Control, Quality Assurance, CAPA, Oral & Written..., Validation, Medical Devices, Pharmaceutics, Quality Auditing, Regulatory Affairs, ISO 13485, Software Documentation, V&V, GMP, Sop, SDLC, Biotechnology, LIMS, Document Management, Pharmaceutical Industry, Cross-functional Team..., Process Improvement, Lifesciences, Quality System, GLP, GAMP, Regulatory Requirements, GCP, Biopharmaceuticals, Quality Control, Protocol, Testing, SOP

Education
Wheaton College   1977 — 1979
Accounting and Finance

Oral Roberts University   1973 — 1977
BS, CSC, Math

Olga Gutman-Gibson Olga Gutman-Gibson Philadelphia, Pennsylvania Details
Olga Gutman-Gibson's Azzur Group Experience August 2013 - February 2015
Job Office Assistant at Azzur Group
Industry Pharmaceuticals
Experience
Azzur Group   August 2013 - February 2015
Checker Cab   May 2010 - February 2013
Environmental Tectonics Corp  July 2007 - April 2009

Skills
Sop, Pharmaceutical Industry, GMP, Quality Assurance, Software Documentation, Transportation, Validation, Logistics, 21 CFR Part 11, V, Microsoft Office, Customer Service, Microsoft Excel, Microsoft Word, Salesforce.com..., QuickBooks, Quicken, FDCPA, Travel Arrangements, Business Travel, Travel Management, Collections, Office Administration, Back Office, Employee Benefits

Education
Community College of Philadelphia   2009 — 2015
Business Administration and Management, General

George Washington High School

Matthew Nagurney Matthew Nagurney Greater New York City Area Details
Matthew Nagurney's Azzur Group Experience October 2011 - August 2012
Job Compliance Audit Specialist at Medtronic Spinal & Biologics
Industry Biotechnology
Experience
Medtronic Spinal & Biologics  November 2014 - Present
Medtronic, Inc.   June 2012 - November 2014
AZZUR GROUP   October 2011 - August 2012
Celgene Corporation - LifeBank   August 2011 - December 2011
New York Blood Center  April 2008 - July 2010
Progenitor Cell Therapy L.L.C   May 2005 - April 2008
Wyeth Pharmaceuticals  May 2004 - April 2005
Schering-Plough Corporation  February 2003 - April 2004
Curative Health Services  January 2000 - February 2003
Curative Health Services  July 1998 - December 1999

Skills
FDA, GMP, Sop, Validation, CAPA, Biotechnology, Change Control, Pharmaceutical Industry, 21 CFR Part 11, Lifesciences, Quality System, Quality Assurance, Aseptic Processing, GxP, GLP, V&V, Regulatory Affairs, Medical Devices, LIMS, Computer System..., Laboratory, Quality Auditing, Quality Control, ISO 13485, Quality Management, Microbiology, Process Improvement, Deviations, Calibration, Biopharmaceuticals, Trackwise, Testing, HPLC, GAMP, Cleaning Validation, Technology Transfer, Manufacturing, FDA GMP, Regulatory Requirements, Regulatory Submissions, Design Control, Chromatography, Root Cause Analysis, GCP, Analytical Chemistry, ISO, Life Sciences

Education
Lycoming College   1987 — 1991
BA, Biology

Temple University
Partial Masters, Pharmaceutical Quality Control

Allison Sanborn Allison Sanborn Lebanon, New Hampshire Details
Allison Sanborn's Azzur Group Experience January 2015 - May 2015
Job Exemplary Skills to support your Company
Industry Executive Office
Experience
Technical Needs  August 2015 - Present
Azzur Group   January 2015 - May 2015
Dartmouth-Hitchcock  September 2013 - November 2014
Dartmouth College  January 2012 - November 2014
TDB Communications  December 2012 - April 2013
Keystone Financial Co.   January 2011 - June 2011
State Street School   August 2010 - June 2011
SAU #88   October 1994 - June 2008

Skills
Organizational..., Computer Literate, Public Speaking, Customer Relations, Budgeting, Fundraising, Organization &..., Budgets, Critical Thinking, Research, Music, Report Development, Account Management, Administrative..., Administrative Work, Customer Service, New Business Development, Process Improvement, Grant Writing, Microsoft Office, Project Planning, Event Planning, Time Management, Nonprofits, Community Outreach, Social Networking, Data Entry, Administration, Teaching, Team Building, Management, Strategic Planning, Microsoft Excel, Healthcare, Program Development, Leadership, Training, Marketing, Policy, Microsoft Word, Social Media, Sales, PowerPoint, Problem Solving, Editing

Education
Grand Canyon University   2011 — 2013
M.C.S., Master Degree in Christian Studies, 3.8

Lesley University   1992 — 1994
M.Ed., Master of Special Education, 3.7

Ithaca College   1979 — 1983
B. Med., Vocal Music Education

Lebanon High School, New Hampshire   1975 — 1979
High School, Diploma

Chris Mansur Chris Mansur Greater Boston Area Details
Chris Mansur's Azzur Group Experience March 2013 - Present
Job Azzur Group LLC, General Manager, New England
Industry Pharmaceuticals
Experience
Azzur Group   March 2013 - Present
OPK Biotech   February 2010 - March 2013
Shire HGT  October 2007 - February 2010
Genentech  December 2003 - October 2007
Pfizer  June 2001 - December 2003
Pfizer  December 2000 - June 2001
CSL Behring  June 2000 - December 2000
Biopure  December 1997 - June 2000
PAREXEL (KMI)   November 1994 - December 1997

Skills
21 CFR Part 11, Computer System..., Validation, GMP, Change Control, CAPA, FDA, V&V, Sop, GAMP, Quality System, GxP, Aseptic Processing, Biotechnology, Technology Transfer, Cleaning Validation, Quality Assurance, Biopharmaceuticals, Quality Control, Chromatography, Trackwise

Education
Boston College - Wallace E. Carroll Graduate School of Management   1999 — 2001
MBA

Worcester Polytechnic Institute   1990 — 1994
Bachelors of Science, BioMechanical Engineering

Gabriel Abreu Gabriel Abreu Revere, Massachusetts Details
Gabriel Abreu's Azzur Group Experience April 2015 - Present
Job Engineer I at Azzur Group
Industry Mechanical or Industrial Engineering
Experience
Azzur Group   April 2015 - Present
University of Massachusetts Amherst  September 2012 - December 2014
Fluid Structure Interactions Laboratory   November 2012 - May 2013
CFAM Technologies   May 2012 - July 2012
Industrial Aerodynamics Laboratory   September 2011 - December 2011

Skills
Matlab, SolidWorks, ANSYS, Fluid Mechanics, Finite Element Analysis, Engineering, Microsoft Office, Simulations, LabVIEW, Problem Solving, Leadership

Education
University of Massachusetts, Amherst   2012 — 2014
Bachelor of Science (B.S.), Mechanical Engineering

Beverly Flight Center   2010 — 2012
Flight Operations, Private Pilot Certificate

University of Massachusetts Lowell   2010 — 2011
Bachelor's Degree, Mechanical Engineering

Revere High School   2006 — 2010
High School

Brad Lozan Brad Lozan Orange County, California Area Details
Brad Lozan's Azzur Group Experience May 2014 - Present
Job General Manager, Azzur California
Industry Pharmaceuticals
Experience
Azzur Group   May 2014 - Present
BioSPEQ  November 2012 - Present
Teva Pharmaceuticals  November 2010 - November 2012
Teva Parenteral Medicines  November 2009 - November 2010
A. D. Brown Corporation, General Engineering Contractors   2005 - November 2009
Baxter Healthcare  2000 - 2005
Baxter Healthcare  1998 - 1998

Skills
Manufacturing, Engineering, Validation, GMP, FDA, CAPA, V&V, Quality System, Change Control, Technology Transfer, Sop, Pharmaceutical Industry, Biotechnology, Cleaning Validation, Medical Devices, 21 CFR Part 11, Six Sigma, Lean Manufacturing, Biopharmaceuticals, Maintenance, Critical Systems, Water, HVAC, Trackwise, Aseptic Processing, Regulatory Requirements, Quality Auditing, SOP

Education
Iowa State University   1995 — 2000
B.S., Chemical Engineering

crystal lake central

Chris Flocco Chris Flocco Greater Philadelphia Area Details
Chris Flocco's Azzur Group Experience 2014 - 2014
Job IT Lead, Computer Systems at Johnson & Johnson
Industry Pharmaceuticals
Experience
Johnson & Johnson  September 2012 - Present
Azzur Group   2014 - 2014
Siemens Healthcare  March 2012 - August 2012
Medimedia, USA  April 2008 - February 2012
IPS  July 2007 - April 2008
MediMedia USA  September 2005 - June 2007
Stelex  2000 - 2005

Skills
Quality Assurance, 21 CFR Part 11, Validation, Business Process, Requirements Gathering, Change Control, Project Management, CAPA, Team Leadership, Software Documentation, Program Management, Medical Devices, Process Improvement, Computer System..., Requirements Analysis, Siebel, Oracle, Cross-functional Team..., SQL, FDA, GxP, Integration, Pharmaceutical Industry, SDLC, Visio, GMP, Software Quality..., Business Analysis, LIMS, Process Engineering, SharePoint, Testing

Education
Drexel University   1998 — 2001
Master's degree, Information Systems

Drexel University   1991 — 1996
Bachelor of Science (BS), Biology

Charlie Hammer Charlie Hammer Greater New York City Area Details
Charlie Hammer's Azzur Group Experience March 2012 - August 2015
Job Staff (Principal) Validation Engineer at Integra LifeSciences
Industry Pharmaceuticals
Experience
Integra LifeSciences  August 2015 - Present
Azzur Group   March 2012 - August 2015
Integra LifeSciences  July 2014 - November 2014
West-Ward Pharmaceuticals  March 2012 - February 2014
Bristol Myers Squibb  2011 - March 2012
Integrated Project Services (IPS)   2007 - August 2011
Cardiovascular Research Foundation  September 2007 - May 2011
Unilife Corporation  November 2010 - April 2011
Forest Laboratories  August 2010 - February 2011
Wyeth  2007 - 2009

Skills
Process Validation, Computer System..., 21 CFR Part 11, Validation, SOP, GMP, cGMP, GxP, GAMP, V&V, Sop, Quality Assurance, GLP, CAPA, Testing, Quality Auditing, FDA, Pharmaceutical Industry, Commissioning, Medical Devices, Quality Management, Manufacturing, Change Control, Biopharmaceuticals, Cleaning Validation, Aseptic Processing, Protocol Development, Building Automation

Education
Rutgers College of Engineering
Bachelor's degree, Chemical and Biochemical Engineering

Middlesex County College
Associate of Science (AS), Chemical Engineering

Elsa Pimentel Elsa Pimentel Puerto Rico area Details
Elsa Pimentel's Azzur Group Experience January 2015 - March 2015
Job Validation Engineer at Azzur Group
Industry Pharmaceuticals
Experience
Azzur Group   January 2015 - March 2015
Neolpharma S.A. de C.V:   May 2014 - November 2014
BMS  December 2013 - January 2014
Pfizer Barceloneta   February 2013 - September 2013
Benevue Pharma   November 2010 - December 2010
Patheon Pharma   September 2009 - December 2009
Catalent Pharma Solutions  August 2008 - November 2008
Invensys Validation Technology   March 2007 - June 2008
Skanska Pharma   February 2004 - March 2007
Foster Wheeler  February 2001 - February 2004

Skills
Validation, Quality Systems, Cleaning Validation, SOP, Process Validation, Commissioning, HVAC, CAPA, GMP, cGMP, Quality Assurance, Pharmaceuticals, Biotechnology, Auditing, Compliance, LIMS, Six Sigma, Documentation, Testing, Computer System..., Investigations, 21 CFR Part 11, Automation, Lean Manufacturing, Medical Devices, Validations, Analysis, GAMP, Change Control, V&V, Software Documentation, Pharmaceutical Industry, Private Investigations, Sop, Quality System, FDA, HPLC, Quality Control, Analytical Chemistry, Manufacturing, Quality Auditing, GxP, Process Simulation, ISO 13485, ISO, Root Cause Analysis, Aseptic Processing, Biopharmaceuticals, Trackwise, Calibration

Education
Universidad Politecnica de PR   1989 — 1996
B.S, Engineering; Industrial Engineering

Universidad Inter Americana de Puerto Rico Chemist   1983 — 1984
BS, Natural Science; Chemistry

University of South Florida   1977 — 1982
Chemistry

Ravi Samavedam Ravi Samavedam Greater Boston Area Details
Ravi Samavedam's Azzur Group Experience May 2014 - Present
Job General Manager at Azzur Group
Industry Biotechnology
Experience
Azzur Group   May 2014 - Present
BioSPEQ  July 2012 - Present
Shire HGT  December 2008 - June 2012
Amgen  August 2003 - December 2008
Baxter BioScience  August 2000 - June 2003

Skills
Process Validation, cGMP, Disposables, Cleaning Validation, CMC, Biotech Manufacturing, Aseptic Processing, Technology Transfer, Regulatory Submissions, Extractables and..., Cold Chain..., Validation Maintenance, Validation, V&V, Biotechnology, GMP, Quality Control, Biopharmaceuticals, 21 CFR Part 11, Change Control, FDA, Computer System..., CAPA, Pharmaceutics, Sop, Pharmaceutical Industry, LIMS, SOP

Education
University of Minnesota-Twin Cities   1997 — 2000

HBTI, Kanpur   1993 — 1997
B. Tech, Biochemical Engineering

BJB College   1990 — 1993

B.L. Robinson B.L. Robinson San Francisco Bay Area Details
B.L. Robinson's Azzur Group Experience May 2014 - Present
Job Validation Engineer Consultant at Azzur Group
Industry Pharmaceuticals
Experience
Azzur Group   May 2014 - Present
Experis Manpower   February 2014 - March 2014
Versa Engineering & Technology  September 2013 - January 2014
TalentBurst, Inc. (Consultant)   January 2013 - June 2013
PharmEng Technology  November 2008 - September 2011
InfoQuest Consulting Group   December 2010 - February 2011
Ryzen Solutions (Broncus Technologies, Inc.)   July 2008 - November 2009
Tac Worldwide (Genentech)   January 2008 - March 2008
Adecco Technical (Novartis, Inc., Bayer Healthcare)   July 2007 - October 2007
Genentech  November 2005 - July 2006

Skills
Validation, GMP, FDA, Sop, Quality System, CAPA, Quality Assurance, V&V, Biotechnology, Medical Devices, Biopharmaceuticals, LIMS, Computer System..., Software Documentation, Quality Control, Clinical Trials, GAMP, Change Control, 21 CFR Part 11, ISO 13485, HPLC, Pharmaceutics, Laboratory, GLP, GxP, Regulatory Affairs, Technology Transfer, Regulatory Requirements, Pharmaceutical Industry, Cleaning Validation, Chemistry, Regulatory Submissions, Lifesciences, Document Management, GCP, R&D, Technical Writing, SOP, Life Sciences

Education
San Diego State University-California State University
Bachelor's Degree, Chemistry

Skyline College   2007 — 2007
Biotechnoloy Manufacturing Certificate, BioManufacturing / Biotechnology

St. Michael's High, Los Angeles, CA

Shannon Wills Shannon Wills Austin, Texas Area Details
Shannon Wills's Azzur Group Experience October 2014 - February 2015
Job Senior Consultant at MicroWorks, Inc.
Industry Pharmaceuticals
Experience
MicroWorks, Inc.   November 2010 - Present
Azzur Group   October 2014 - February 2015
Grifols/Biomat USA, Inc.   October 2008 - November 2010
Baxter Biopharmaceutical Solutions   April 2007 - October 2008
TYCO Healthcare Mallinckrodt Imaging   July 2006 - December 2006
CellzDirect; Austin, TX   May 2005 - July 2006
MicroPharm, Inc. and Micropharm Consulting, Inc.; St. Charles, IL and Georgetown, TX   April 1995 - May 2005
Fujisawa USA, Inc., Melrose Park, IL   February 1993 - April 1995
Kendall McGaw (B.Braun)   April 1987 - September 1988
Allergan Medical Optics  1985 - 1987

Skills
GLP, Pharmaceutical Industry, Validation, Quality System, CAPA, GMP, Quality Assurance, LIMS, Quality Control, Biotechnology, FDA, Aseptic Technique, Aseptic Processing, Cross-functional Team..., Microbiology, Environmental Monitoring, Laboratory, Pharmaceutical..., HPLC

Education
California State University-Long Beach   1979 — 1983
Bachelor of Science, Microbiology, General

Nicole Labrecque Nicole Labrecque Greater Boston Area Details
Nicole Labrecque's Azzur Group Experience August 2014 - Present
Job Validation Engineer at Azzur Group
Industry Biotechnology
Experience
Azzur Group   August 2014 - Present
Merck  January 2012 - April 2014
Merck  July 2008 - January 2012
Garlock Sealing Technologies  June 2007 - August 2007
Saint-Gobain Abrasives  May 2006 - August 2006

Skills
Manufacturing, Change Control, Engineering, GMP, Vaccines, Validation, Sterilization, Chromatography, Quality Assurance, Six Sigma, Sop, Technology Transfer, Quality Control, Filtration, CAPA, Deviation Management, SOP, Pharmaceutical Industry, FDA

Education
Rensselaer Polytechnic Institute   2004 — 2008
B.S., Chemical and Biological Engineering

St. Peter Marian

Hiral Kadakia Hiral Kadakia Greater Los Angeles Area Details
Hiral Kadakia's Azzur Group Experience February 2015 - Present
Job Validation Engineer
Industry Pharmaceuticals
Experience
Azzur Group   February 2015 - Present
Actavis Inc. (Watson Pharmaceuticals)   July 2006 - January 2015
Viral Genetics   January 2006 - March 2006
Watson Pharmaceuticals  June 2005 - December 2005
Baxter International Inc.  October 2004 - May 2005

Skills
Cleaning Validation, Process Validation, GMP, Change Control, Technology Transfer, CAPA, LIMS, SOP development, Deviation Investigation, 21 CFR Part 11, Trackwise, JMP, SOP, FDA, Validation, Pharmaceutical Industry, V&V, Quality System, Deviations, GLP, GxP, Sop, TrackWise, Computer System..., V, ICH Guidelines

Education
Florida Agricultural and Mechanical University   2000 — 2004
Masters, Chemistry

Gujarat University   1996 — 1998
Chemistry

Carmen Di Julio Carmen Di Julio Greater Philadelphia Area Details
Carmen Di Julio's Azzur Group Experience May 2013 - April 2014
Job Computer Software Validation Engineer
Industry Information Technology and Services
Experience
Depuy-Synthes - Companies of Johnson & Johnson  April 2014 - Present
Azzur Group   May 2013 - April 2014
NextDocs  April 2012 - March 2013
ePharmaSolutions  January 2010 - March 2012
Wyeth  January 2009 - June 2009
CSC  April 2008 - November 2008
First Consulting Group  2001 - 2008

Skills
Quality Assurance, SDLC, Testing, SharePoint, Requirements Analysis, Software Documentation, Validation, Document Management, 21 CFR Part 11, Computer System..., Requirements Gathering, Pharmaceutical Industry, Business Analysis, System Testing, GxP, Documentum, Software Development, Integration, Process Improvement, Software Validation, Sop, Change Control, Project Management, Test Director, FirstDoc, Cross-functional Team..., Compliance, Agile, SOP, Software Quality..., Software Project..., Consulting, Enterprise Software, FDA, CAPA, Clinical Trials, Leadership, Documentation, IT Strategy, Life Sciences, Business Process, Quality System

Education
Immaculata University   2004 — 2007
BS, Information Technology

Michael Khavinson Michael Khavinson Greater Philadelphia Area Details
Michael Khavinson's Azzur Group Experience January 2010 - Present
Job Managing Partner at Azzur
Industry Pharmaceuticals
Experience
Azzur   2013 - Present
Azzur Group   January 2010 - Present
CQV LLC   January 2008 - December 2009
ACME RailRoad Co., Inc.   2006 - 2009
Stelex Inc.   1987 - September 2005
Vital Signs  2003 - 2004
w.p. carey   1987 - 1992
Robec Distributors  1986 - 1987

Skills
Validation, FDA, Medical Devices, Quality Assurance, Cross-functional Team..., Pharmaceutical Industry, Process Improvement, GMP, Business Strategy, Project Management, New Business Development, Quality System, Start-ups, Enterprise Content..., Team Building, Strategic Planning, Contract Negotiation, Document Management, SaaS, Enterprise Software

Education
Temple University   1982 — 1987
BA, computer science

Chris Fostek Chris Fostek Greater Philadelphia Area Details
Chris Fostek's Azzur Group Experience July 2012 - March 2014
Job Research Analyst
Industry Pharmaceuticals
Experience
JLL  February 2015 - Present
Laporte Consultants  March 2014 - December 2014
Azzur Group   July 2012 - March 2014
Trinitas Regional Medical Center  June 2006 - December 2009

Skills
21 CFR Part 11, V&V, Change Control, Computer System..., Validation, CAPA, GxP, GMP, FDA, GAMP, Sop, Aseptic Processing, Quality System, Technology Transfer, Pharmaceutical Industry, Biopharmaceuticals, Biotechnology, Quality Assurance, Medical Devices, GLP, Quality Auditing, Regulatory Affairs, LIMS, Technical Documentation, Vaccines

Education
Montclair State University   2002 — 2007
Bachelor of Science (BS), Biology, General

Ocean County College
Associate of Science (A.S.), Biology, General

Kevin F. O'Connor Kevin F. O'Connor Bel Air, Maryland Details
Kevin F. O'Connor's Azzur Group Experience October 2013 - December 2013
Job Sr. Project Manager
Industry Information Technology and Services
Experience
O'Connor & Associates   April 2014 - Present
KPIT  March 2015 - June 2015
Apex Systems  June 2014 - December 2014
Azzur Group   October 2013 - December 2013
Experis  May 2012 - October 2013
CSC  August 2011 - May 2012
William Scotsman  August 2009 - December 2010
O'Connor Consulting, Inc.   October 1999 - October 2009
Catholic Relief Services  October 1999 - October 2009
Catholic Relief Services  October 1999 - October 2009

Skills
Financial Systems, Budgets, Project Management, Project Planning, ERP, JD Edwards, Payroll Systems, Management, Payroll, Analysis, PMO, Training, System Administration, Program Management, Strategy, Databases, Integration, Strategic Planning, Vendor Management, Networking, Leadership, Procurement, Business Intelligence, Information Technology, Business Analysis, Business Process, IT Management, SDLC, SharePoint, Software Documentation, Visio, Business Process..., PMP, PeopleSoft, MS Project, CRM, Process Improvement, IT Strategy, Resource Management, Requirements Analysis, Change Management, Project Portfolio..., ITIL, Project Delivery, Disaster Recovery, IT Service Management, Software Project..., Consulting

Education
Corning Community College
AAS, Computer Science

Corning Community College
Associate Degree, Applied Science; Computer Sciences

Notre Dame High School

Carl Alesi Carl Alesi Greater Philadelphia Area Details
Carl Alesi's Azzur Group Experience June 2010 - Present
Job Validtaion Engineer
Industry Biotechnology
Experience
Azzur Group   June 2010 - Present
Carzo and Associates   2009 - 2010
AMEC  May 2004 - July 2009
Phoenix Imperative, Inc.   July 1997 - May 2004

Skills
Validation, cGMP, Commissioning, V&V, GMP, CAPA

Education
Penn State University   1992 — 1996
BS, Engineering

Keith Tang Keith Tang Greater Boston Area Details
Keith Tang's Azzur Group Experience July 2013 - Present
Job Engineer II at Azzur
Industry Biotechnology
Experience
Azzur Group   July 2013 - Present
The Dennis Group  June 2010 - July 2013
Tufts University  January 2010 - May 2010
Biogen Idec  June 2009 - August 2009
Biogen Idec  June 2008 - August 2008

Skills
Engineering, Process Design, PFD, PIDs, Process Descriptions, Commissioning, AutoCAD, PowerPoint, Excel, Word, Project Engineering

Education
Tufts University   2006 — 2010
Bachelor of Science, Chemical and Biological Engineering

Jordan Pan Jordan Pan Greater Los Angeles Area Details
Jordan Pan's Azzur Group Experience June 2014 - Present
Job Engineer at Azzur Group
Industry Pharmaceuticals
Experience
Azzur Group   June 2014 - Present
National University  July 2012 - June 2014
Laerdal Medical  May 2011 - August 2012
General Photonics  June 2009 - March 2012
General Photonics  March 2008 - June 2009
Quickly Café   July 2006 - June 2009
Handicapper.net   July 2004 - September 2006
South Pasadena and San Marino YMCA   March 2004 - July 2006

Education
National University   2013 — 2014
Master of Science (MS), Computer Science

California State Polytechnic University   2004 — 2009
Bachelor of Science, Electronics and Computer Engineering Technology

Temple City High School   2000 — 2004
High School Degree

Dean Isildakli Dean Isildakli Greater Boston Area Details
Dean Isildakli's Azzur Group Experience June 2013 - Present
Job Engineer II at Azzur Group
Industry Mechanical or Industrial Engineering
Experience
Azzur Group   June 2013 - Present
Lonza  July 2011 - June 2013

Skills
Validation, Chromatography, GMP, Manufacturing, Protein Purification, Engineering, Finite Element Analysis, COMSOL, Biotechnology, Active Pharmaceutical..., Column Chromatography, Column Packing, Clean Rooms, Document Review, UF/DF, Solidworks, CAPA, Purification, V&V

Education
Boston University   2007 — 2011
Bachelor's Degree, Mechanical Engineering

St. Johns High School (Shrewsbury)   2003 — 2007

Andrew Matheson Andrew Matheson Greater Los Angeles Area Details
Andrew Matheson's Azzur Group Experience April 2015 - Present
Job Validation Specialist
Industry Biotechnology
Experience
Azzur Group   April 2015 - Present
Validation Technologies, Inc.   July 2008 - January 2015
USDM  September 2010 - February 2011

Skills
Cleaning Validation, Validation, Autoclave, LIMS, Pharmaceutical Industry, 21 CFR Part 11, V&V, Aseptic Processing, CAPA, GAMP, Computer System..., SOP, FDA, CIP, Change Control, Trackwise, GMP, Manufacturing, GxP, GLP

Education
California Polytechnic State University-San Luis Obispo

Michael DeGirolamo Michael DeGirolamo Reading, Massachusetts Details
Michael DeGirolamo's Azzur Group Experience August 2015 - Present
Job Engineer I at Azzur Group
Industry Biotechnology
Experience
Azzur Group   August 2015 - Present
Glycan Connections   May 2014 - July 2015
East Boston Savings Bank  July 2012 - May 2014
New England Rehabilition Hospital   June 2011 - April 2013

Skills
Microsoft Office, Molecular Biology, Biotechnology, PCR, Microsoft Excel, PowerPoint, Research, Cell Culture, Microsoft Word, Lifesciences, Biochemistry, Microbiology, Western Blotting, Teamwork, Gel Electrophoresis, Customer Service, SDS-PAGE, Life Sciences

Education
University of New Hampshire   2010 — 2014
BS, Biochemistry and Molecular Biology

Roland Cucinella, ASQ CQA Roland Cucinella, ASQ CQA Greater Boston Area Details
Roland Cucinella, ASQ CQA's Azzur Group Experience 2015 - Present
Job Compliance Consultant at Azzur Group
Industry Pharmaceuticals
Experience
Azzur Group   2015 - Present
Bristol-Myers Squibb  2010 - 2015
Lonza  2007 - 2010
Amgen  2006 - 2007
Baxter International Inc.  2003 - 2006

Skills
ASQ Member, • Knowledge of federal..., Extensive training..., Pharmaceutical Industry, GMP, Validation, Sop, FDA, 21 CFR Part 11, CAPA, Change Control, Regulatory Affairs, GLP, Clinical Trials, Computer System..., Biotechnology, V&V, GCP, Quality System, Clinical Development, HPLC, GxP, Quality Assurance, Internal Audit, External Audit, Biopharmaceuticals, LIMS

Education
Chaffey College   2005 — 2006
Biological and Physical Sciences

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