Safis-Solutions, LLC
Description
Address: 303 N Alabama St #210, Indianapolis, IN 46204 Phone: (317) 777-6200: Place name: Website: : Category: : : : Hours: : Website: http://www.safis-solutions.com/ Category: Consultant Suggest an editUnable to add this file. Please check that it is a valid photo. Unable to add this file. Please check that it is a valid photo.Add missing informationAdd business hours Unable to add this file. Please check that it is a valid photo. Questions & answers Ask a questionBe the first to ask a question Add a photoThanks for sharing!Your photo will be posted publicly on Google.Contribute MoreDoneUpload public photos of Safis Solutions, LLC Posting publicly on the Web Write a review Reviews Be the first to review
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Safis-Solutions, LLC Employees
Employee
Years
Job
Industry
ChiaYee Ang ChiaYee Ang's Safis-Solutions, LLC Experience December 2013 - April 2014
Job Results Driven Professional with Medical Device R&D/RA Experiences (TriLingual)
Industry Medical Devices
Experience
Eli Lilly and Company May 2014 - Present
Safis Solutions, LLC December 2013 - April 2014
Hologic November 2010 - September 2013
Hologic March 2008 - October 2010
Carrier Corporation August 2005 - February 2008
Carrier Corporation July 2002 - June 2005
Carrier Corporation July 2000 - June 2002
Skills
FMEA, Medical Devices, Engineering, Product Development, ISO 13485, Design Control, Quality System, Root Cause Analysis, Design of Experiments, Design for Manufacturing, Manufacturing..., SPC, V&V, CAPA, FDA, Injection Molding, Validation
Education
Purdue University - Krannert School of Management
Executive MBA, Engineering Management
Indiana University-Purdue University at Indianapolis 2001 — 2004
Master of Science (M.S.), Mechanical Engineering
Indiana University-Purdue University at Indianapolis 1998 — 2000
Bachelor of Science (B.S.), Mechanical Engineering
Eli Lilly and Company May 2014 - Present
Safis Solutions, LLC December 2013 - April 2014
Hologic November 2010 - September 2013
Hologic March 2008 - October 2010
Carrier Corporation August 2005 - February 2008
Carrier Corporation July 2002 - June 2005
Carrier Corporation July 2000 - June 2002
Skills
FMEA, Medical Devices, Engineering, Product Development, ISO 13485, Design Control, Quality System, Root Cause Analysis, Design of Experiments, Design for Manufacturing, Manufacturing..., SPC, V&V, CAPA, FDA, Injection Molding, Validation
Education
Purdue University - Krannert School of Management
Executive MBA, Engineering Management
Indiana University-Purdue University at Indianapolis 2001 — 2004
Master of Science (M.S.), Mechanical Engineering
Indiana University-Purdue University at Indianapolis 1998 — 2000
Bachelor of Science (B.S.), Mechanical Engineering
Michele E. Ware Michele E. Ware's Safis-Solutions, LLC Experience April 2009 - November 2009
Job CEO & President
Industry Management Consulting
Experience
Strategic Global Advantage Associates LLC. November 2009 - Present
Safis Solutions, LLC April 2009 - November 2009
Roche Diagnostics August 2004 - March 2009
Skills
Strategic Thinking, Visionary, Entrepreneurship, Full P&L Responsibility, Critical Thinking, Executive Coaching, Iso 9000, Executive Management, Business Strategy, New Business Development, Business Process..., Record Of Success, Bilingual, Strategy, P&L Management, Business Development, Management, Consulting, Leadership, Enterprise Software, CRM, Process Improvement, Marketing, Sales Management, Cross-functional Team..., Human Resources, Risk Management
Education
Illinois State University 1978 — 1982
BS, Marketing/Spanish- International Business
La Universidad Iberoamericana 1980 — 1981
BS, Spanish
Strategic Global Advantage Associates LLC. November 2009 - Present
Safis Solutions, LLC April 2009 - November 2009
Roche Diagnostics August 2004 - March 2009
Skills
Strategic Thinking, Visionary, Entrepreneurship, Full P&L Responsibility, Critical Thinking, Executive Coaching, Iso 9000, Executive Management, Business Strategy, New Business Development, Business Process..., Record Of Success, Bilingual, Strategy, P&L Management, Business Development, Management, Consulting, Leadership, Enterprise Software, CRM, Process Improvement, Marketing, Sales Management, Cross-functional Team..., Human Resources, Risk Management
Education
Illinois State University 1978 — 1982
BS, Marketing/Spanish- International Business
La Universidad Iberoamericana 1980 — 1981
BS, Spanish
Kim Bauer, CQA's Safis-Solutions, LLC Experience September 2012 - Present
Job Compliance and Business Analyst Professional at Pharmaceutical, Biotech, Medical Device & other FDA regulated industries
Industry Biotechnology
Experience
Safis Solutions, LLC September 2012 - Present
Pfizer Pharmaceuticals June 2007 - October 2011
Pfizer January 2004 - June 2007
Pfizer June 2001 - January 2004
Duke Center for Human Genetic 1999 - 2001
HF Scientific 1992 - 1999
Indiana University Bloomington 1988 - 1991
Skills
Business Analysis, System Administration, Project Implementation, Enterprise Software, Requirements Gathering, Requirements..., Requirements Management, Gap Analysis, Concensus Building, Workflow Analysis, Computer System..., Master Data Management, User Acceptance Testing, Validation, Application Lifecycle..., Change Management, Software Configuration..., Quality Systems, Quality Management, Document Management, Technical Documentation, Hyperion, SAP, CAPA, Documentum, SharePoint, PeopleSoft, Microsoft Office, Excel, Visio, MS Project, Technical Training, Software Training, 21 CFR Part 11, Clinical Development, MES, Pharmaceuticals, Biotechnology, LIMS, GMP, Sop, Cross-functional Team..., Lifesciences, Quality System, Pharmaceutical Industry, Regulatory Affairs, Change Control, Quality Assurance
Education
Indiana University Bloomington 1981 — 1986
BS, Biochemistry
Safis Solutions, LLC September 2012 - Present
Pfizer Pharmaceuticals June 2007 - October 2011
Pfizer January 2004 - June 2007
Pfizer June 2001 - January 2004
Duke Center for Human Genetic 1999 - 2001
HF Scientific 1992 - 1999
Indiana University Bloomington 1988 - 1991
Skills
Business Analysis, System Administration, Project Implementation, Enterprise Software, Requirements Gathering, Requirements..., Requirements Management, Gap Analysis, Concensus Building, Workflow Analysis, Computer System..., Master Data Management, User Acceptance Testing, Validation, Application Lifecycle..., Change Management, Software Configuration..., Quality Systems, Quality Management, Document Management, Technical Documentation, Hyperion, SAP, CAPA, Documentum, SharePoint, PeopleSoft, Microsoft Office, Excel, Visio, MS Project, Technical Training, Software Training, 21 CFR Part 11, Clinical Development, MES, Pharmaceuticals, Biotechnology, LIMS, GMP, Sop, Cross-functional Team..., Lifesciences, Quality System, Pharmaceutical Industry, Regulatory Affairs, Change Control, Quality Assurance
Education
Indiana University Bloomington 1981 — 1986
BS, Biochemistry
C. Terry Phillips C. Terry Phillips's Safis-Solutions, LLC Experience October 2005 - September 2007
Job Professional Human Being
Industry Retail
Experience
Circle K September 2014 - Present
RGIS Inventory Specialists September 2012 - October 2013
RCI (Resort Condominiums International) January 2011 - November 2011
Despain Home Inspections/Property Services January 2008 - November 2010
Safis Solutions, LLC October 2005 - September 2007
Theoris / Analysts International (AiC) / Computer Task Group (CTG) March 2002 - October 2005
Bindley Western Drug Company January 1995 - January 2002
Skills
Desktop computer..., Spanish language skills..., Customer Service, Technical Writing,..., Training / Teaching, Commercial Driving, Intel/AMD-based PCs, Apple Macintosh PCs, AS400 and DEC VAX..., Microsoft Office..., Photoshop, Windows (3.1 to..., Mac OSX (Jaguar, all..., RPG III & IV (limited..., HTML, DreamWeaver, IE, Firefox,, Safari, Spanish (written,..., Microsoft Office, Music, Dreamweaver, Microsoft Excel, Microsoft Word, Technical Writing, PowerPoint, Software Documentation, Teaching
Education
IUPUI/Indiana Univ-Purdue Univ at Indianapolis 1985 — 1987
Bachelor of General Studies (Honors), Music, History and historical research, English, and Writing, 3.85 out of 4.00
Brigham Young University 1975 — 1980
As indicated earlier, Music Education moving to Music Performance.
Circle K September 2014 - Present
RGIS Inventory Specialists September 2012 - October 2013
RCI (Resort Condominiums International) January 2011 - November 2011
Despain Home Inspections/Property Services January 2008 - November 2010
Safis Solutions, LLC October 2005 - September 2007
Theoris / Analysts International (AiC) / Computer Task Group (CTG) March 2002 - October 2005
Bindley Western Drug Company January 1995 - January 2002
Skills
Desktop computer..., Spanish language skills..., Customer Service, Technical Writing,..., Training / Teaching, Commercial Driving, Intel/AMD-based PCs, Apple Macintosh PCs, AS400 and DEC VAX..., Microsoft Office..., Photoshop, Windows (3.1 to..., Mac OSX (Jaguar, all..., RPG III & IV (limited..., HTML, DreamWeaver, IE, Firefox,, Safari, Spanish (written,..., Microsoft Office, Music, Dreamweaver, Microsoft Excel, Microsoft Word, Technical Writing, PowerPoint, Software Documentation, Teaching
Education
IUPUI/Indiana Univ-Purdue Univ at Indianapolis 1985 — 1987
Bachelor of General Studies (Honors), Music, History and historical research, English, and Writing, 3.85 out of 4.00
Brigham Young University 1975 — 1980
As indicated earlier, Music Education moving to Music Performance.
Todd Hubbard's Safis-Solutions, LLC Experience June 2011 - October 2011
Job Program Manager Revenue Cycle Services
Industry Hospital & Health Care
Experience
Indiana University Health May 2015 - Present
Indy Premier Soccer Club June 2013 - Present
Massage Therapy Board at Indiana Professional Licensing Agency June 2012 - Present
MMY Consulting January 2014 - May 2015
MMY Consulting April 2012 - May 2015
MMY Consulting October 2011 - December 2013
Safis Solutions, LLC June 2011 - October 2011
Chrysalis Consulting, LLC January 2010 - November 2010
Crowe Horwath LLP April 2002 - December 2009
Crowe Horwath LLP June 1989 - December 2009
Skills
Project Management, Sales Management, Salesforce.com, Process Improvement, Business Process..., Business Analysis, New Business Development, Consultative Selling, Customer Relations, Sales Process, Direct Sales, Project Planning, Software Project..., Contract Negotiations, Microsoft Dynamics, Microsoft CRM, Forecasting, Professional Services, Software Consulting, Enterprise Content..., Contract Negotiation, Proposal Writing, Strategic Planning, SharePoint, Cloud Computing, Coaching, Solution Selling, Business Process, Customer Service, Change Management, Selling, Management, Strategy, Business Development, Consulting, Leadership, CRM, Enterprise Software, Program Management, Account Management, Sales, Integration
Education
Indiana University 1984 — 1989
B.S.
New Palestine High School 1980 — 1984
Indiana University Health May 2015 - Present
Indy Premier Soccer Club June 2013 - Present
Massage Therapy Board at Indiana Professional Licensing Agency June 2012 - Present
MMY Consulting January 2014 - May 2015
MMY Consulting April 2012 - May 2015
MMY Consulting October 2011 - December 2013
Safis Solutions, LLC June 2011 - October 2011
Chrysalis Consulting, LLC January 2010 - November 2010
Crowe Horwath LLP April 2002 - December 2009
Crowe Horwath LLP June 1989 - December 2009
Skills
Project Management, Sales Management, Salesforce.com, Process Improvement, Business Process..., Business Analysis, New Business Development, Consultative Selling, Customer Relations, Sales Process, Direct Sales, Project Planning, Software Project..., Contract Negotiations, Microsoft Dynamics, Microsoft CRM, Forecasting, Professional Services, Software Consulting, Enterprise Content..., Contract Negotiation, Proposal Writing, Strategic Planning, SharePoint, Cloud Computing, Coaching, Solution Selling, Business Process, Customer Service, Change Management, Selling, Management, Strategy, Business Development, Consulting, Leadership, CRM, Enterprise Software, Program Management, Account Management, Sales, Integration
Education
Indiana University 1984 — 1989
B.S.
New Palestine High School 1980 — 1984
Don Poulsen Don Poulsen's Safis-Solutions, LLC Experience July 2003 - Present
Job Vice President, Business Operations at Safis Solutions, LLC
Industry Biotechnology
Experience
Safis Solutions, LLC July 2003 - Present
Argonaut Technologies 2000 - 2003
RealMed 1997 - 2000
Poulsen International 1994 - 1997
Halliburton 1978 - 1994
Education
University of Oklahoma
Master of Science (MS), Petroleum Engineering
The University of New Mexico 1974 — 1978
Bachelor of Science (BS), Chemical Engineering
The University of New Mexico 1973 — 1977
Bachelor of Science (BS), Mathematics
Safis Solutions, LLC July 2003 - Present
Argonaut Technologies 2000 - 2003
RealMed 1997 - 2000
Poulsen International 1994 - 1997
Halliburton 1978 - 1994
Education
University of Oklahoma
Master of Science (MS), Petroleum Engineering
The University of New Mexico 1974 — 1978
Bachelor of Science (BS), Chemical Engineering
The University of New Mexico 1973 — 1977
Bachelor of Science (BS), Mathematics
Lisa Schuster Lisa Schuster's Safis-Solutions, LLC Experience March 2006 - July 2010
Job Software Validation Engineer
Industry Pharmaceuticals
Experience
US Data Management, LLC May 2014 - Present
Lisa Schuster Consulting November 2012 - Present
Care Innovations™, an Intel-GE Company August 2013 - March 2014
Dendreon July 2010 - September 2012
Safis Solutions, LLC March 2006 - July 2010
Commissioning Agents, Inc 2001 - 2006
General Motors Advanced Technology Vehicles - Continental Design Contractor 2000 - 2001
at Magenquench - Continental Design Contractor 1993 - 2000
Delco Remy Division, General Motors 1983 - 1989
Allied Fibers and Plastics (now Honeywell) 1982 - 1983
Skills
Computer System..., 21 CFR Part 11, Part 820, ISO 14971, ISO 13485, NDA, CMC development, eCTD, Equipment Qualification, Engineering Statistics, Clean Rooms, Delta V, C++, Electronic Signatures, Taguchi, Shainin, Design of Experiments, Cpk, Process Capability, Gage R & R, FDA, Validation, Quality System, Change Control, CAPA, GMP, Quality Assurance, Quality Auditing, Regulatory Affairs, Medical Devices, GxP, Process Simulation, Software Documentation, Biotechnology, ISO, Regulatory Requirements, Process Engineering, GAMP, Testing, V&V, Biopharmaceuticals, GLP
Education
Case Western Reserve University 1978 — 1982
B.S., Chemical Engineering
US Data Management, LLC May 2014 - Present
Lisa Schuster Consulting November 2012 - Present
Care Innovations™, an Intel-GE Company August 2013 - March 2014
Dendreon July 2010 - September 2012
Safis Solutions, LLC March 2006 - July 2010
Commissioning Agents, Inc 2001 - 2006
General Motors Advanced Technology Vehicles - Continental Design Contractor 2000 - 2001
at Magenquench - Continental Design Contractor 1993 - 2000
Delco Remy Division, General Motors 1983 - 1989
Allied Fibers and Plastics (now Honeywell) 1982 - 1983
Skills
Computer System..., 21 CFR Part 11, Part 820, ISO 14971, ISO 13485, NDA, CMC development, eCTD, Equipment Qualification, Engineering Statistics, Clean Rooms, Delta V, C++, Electronic Signatures, Taguchi, Shainin, Design of Experiments, Cpk, Process Capability, Gage R & R, FDA, Validation, Quality System, Change Control, CAPA, GMP, Quality Assurance, Quality Auditing, Regulatory Affairs, Medical Devices, GxP, Process Simulation, Software Documentation, Biotechnology, ISO, Regulatory Requirements, Process Engineering, GAMP, Testing, V&V, Biopharmaceuticals, GLP
Education
Case Western Reserve University 1978 — 1982
B.S., Chemical Engineering
Lora LaBrash's Safis-Solutions, LLC Experience March 2007 - February 2011
Job Business Analyst at Indiana Department of Revenue
Industry Information Technology and Services
Experience
Indiana Department of Revenue April 2013 - Present
Covance (Contracted through TeamSoft) August 2011 - February 2013
HCC Insurance March 2011 - August 2011
Safis Solutions, LLC March 2007 - February 2011
Theoris 2005 - 2007
Technisource 2003 - 2005
CREW Technical Services 2002 - 2003
Farm Bureau Insurance 1998 - 2001
RCI 1983 - 1998
Skills
21 CFR Part 11, Pharmaceutical Industry, Quality Assurance, Sales, Management, Technical Writing, Testing, SharePoint, Integration, Software Documentation, Leadership, FDA, Validation, Process Improvement, Training, Project Management, EDRMS, GMP, Program Management, SDLC, Business Analysis, Requirements Gathering
Education
Ball State University 1973 — 1977
B.S., History Antropology
Indiana Department of Revenue April 2013 - Present
Covance (Contracted through TeamSoft) August 2011 - February 2013
HCC Insurance March 2011 - August 2011
Safis Solutions, LLC March 2007 - February 2011
Theoris 2005 - 2007
Technisource 2003 - 2005
CREW Technical Services 2002 - 2003
Farm Bureau Insurance 1998 - 2001
RCI 1983 - 1998
Skills
21 CFR Part 11, Pharmaceutical Industry, Quality Assurance, Sales, Management, Technical Writing, Testing, SharePoint, Integration, Software Documentation, Leadership, FDA, Validation, Process Improvement, Training, Project Management, EDRMS, GMP, Program Management, SDLC, Business Analysis, Requirements Gathering
Education
Ball State University 1973 — 1977
B.S., History Antropology
David Tribbett's Safis-Solutions, LLC Experience March 2009 - September 2012
Job Regulatory Affairs Principal at Roche Diagnostics
Industry Medical Devices
Experience
Roche Diagnostics September 2012 - Present
Safis Solutions, LLC March 2009 - September 2012
Roche Diagnostics 1991 - 2009
Skills
Regulatory Affairs, Quality Management, GMP, 21 CFR Part 11, Regulatory Submissions, Medical Devices, FDA, CAPA, Validation, Computer System..., Quality Assurance, Quality System, FDA GMP, Regulatory Requirements, Change Control, GxP, Quality Auditing, Root Cause Analysis
Education
Ball State University 1998 — 2001
MS, Information and Communication Sciences
Ball State University 1987 — 1991
BS, Chemistry
Roche Diagnostics September 2012 - Present
Safis Solutions, LLC March 2009 - September 2012
Roche Diagnostics 1991 - 2009
Skills
Regulatory Affairs, Quality Management, GMP, 21 CFR Part 11, Regulatory Submissions, Medical Devices, FDA, CAPA, Validation, Computer System..., Quality Assurance, Quality System, FDA GMP, Regulatory Requirements, Change Control, GxP, Quality Auditing, Root Cause Analysis
Education
Ball State University 1998 — 2001
MS, Information and Communication Sciences
Ball State University 1987 — 1991
BS, Chemistry
Jonny Salyer, MD Jonny Salyer, MD's Safis-Solutions, LLC Experience November 2007 - February 2008
Job Physician Investigator and Business Development at Lovelace Scientific Resources
Industry Pharmaceuticals
Experience
Lovelace Scientific Resources, Inc. March 2012 - Present
Pearl IRB, LLC May 2010 - June 2013
INC Research (via aquisition of MDS Pharma Services) 2009 - 2009
MDS Pharma Services 2008 - 2009
Safis Solutions, LLC November 2007 - February 2008
Covance CLS 2001 - 2007
Specialty Laboratories 2001 - 2001
College of American Pathologists 1993 - 2001
Greater Albuquerque Medical Association 1993 - 2001
SED Medical Laboratories 1991 - 2000
Skills
Clinical Development, Clinical Trials, Medical Affairs, Clinical Research, Pharmaceutical Industry, Regulatory Affairs, FDA, Drug Development, CRO, Pharmacovigilance, Lifesciences, Clinical Data Management, CTMS, Medical Devices, Cancer, Therapeutic Areas, Oncology, Immunology, GCP, Clinical Monitoring, Regulatory Submissions, Laboratory, Biotechnology, Medicine, Healthcare, Protocol, Infectious Diseases, Medical Writing, IND, Biopharmaceuticals, Internal Medicine, ICH-GCP, Diabetes, EDC, Endocrinology, Pulmonology
Education
University of Utah School of Medicine 1986 — 1991
Post-graduate training, Anatomic and Clinical Pathology
University of Utah School of Medicine 1987 — 1988
Fellowship, Clinical Immunology
Indiana University School of Medicine 1982 — 1986
Medical Doctor, Medicine
Indiana University Bloomington 1977 — 1982
Bachelor of Arts, Chemistry
Indiana University Bloomington 1977 — 1982
bachelor of science, Microbiology
Lovelace Scientific Resources, Inc. March 2012 - Present
Pearl IRB, LLC May 2010 - June 2013
INC Research (via aquisition of MDS Pharma Services) 2009 - 2009
MDS Pharma Services 2008 - 2009
Safis Solutions, LLC November 2007 - February 2008
Covance CLS 2001 - 2007
Specialty Laboratories 2001 - 2001
College of American Pathologists 1993 - 2001
Greater Albuquerque Medical Association 1993 - 2001
SED Medical Laboratories 1991 - 2000
Skills
Clinical Development, Clinical Trials, Medical Affairs, Clinical Research, Pharmaceutical Industry, Regulatory Affairs, FDA, Drug Development, CRO, Pharmacovigilance, Lifesciences, Clinical Data Management, CTMS, Medical Devices, Cancer, Therapeutic Areas, Oncology, Immunology, GCP, Clinical Monitoring, Regulatory Submissions, Laboratory, Biotechnology, Medicine, Healthcare, Protocol, Infectious Diseases, Medical Writing, IND, Biopharmaceuticals, Internal Medicine, ICH-GCP, Diabetes, EDC, Endocrinology, Pulmonology
Education
University of Utah School of Medicine 1986 — 1991
Post-graduate training, Anatomic and Clinical Pathology
University of Utah School of Medicine 1987 — 1988
Fellowship, Clinical Immunology
Indiana University School of Medicine 1982 — 1986
Medical Doctor, Medicine
Indiana University Bloomington 1977 — 1982
Bachelor of Arts, Chemistry
Indiana University Bloomington 1977 — 1982
bachelor of science, Microbiology
Tom Cavanagh Tom Cavanagh's Safis-Solutions, LLC Experience April 2009 - September 2009
Job Principal at Quality and Regulatory Consulting
Industry Biotechnology
Experience
Quality and Regulatory Consulting 2014 - Present
Pearl Pathways 2011 - 2014
Symbios Medical Products October 2010 - June 2013
Symbios Medical Products September 2009 - October 2010
Safis Solutions, LLC April 2009 - September 2009
Roche Diagnostics March 2007 - December 2008
Roche Diagnostics December 2005 - March 2007
Roche Diagnostics January 2004 - December 2005
Roche Diagnostics June 1999 - December 2003
Roche Diagnostics June 1999 - December 2003
Skills
Six Sigma, Quality System, Medical Devices, FDA, Quality Assurance, Regulatory Affairs, Biotechnology, Process Improvement, Training, Product Development, Regulatory Submissions, Quality Management, Pharmaceutical Industry, Leadership, Validation, Manufacturing, CAPA, Lean Manufacturing, ISO 13485, GMP, Commercialization
Education
Indiana University-Purdue University at Indianapolis 1981 — 1992
Medical Neurobiology
State University of New York College at Plattsburgh 1971 — 1977
BS, Medical Technology
Chaminade 1967 — 1971
Carl Place
Carl Place
Carl Place
Quality and Regulatory Consulting 2014 - Present
Pearl Pathways 2011 - 2014
Symbios Medical Products October 2010 - June 2013
Symbios Medical Products September 2009 - October 2010
Safis Solutions, LLC April 2009 - September 2009
Roche Diagnostics March 2007 - December 2008
Roche Diagnostics December 2005 - March 2007
Roche Diagnostics January 2004 - December 2005
Roche Diagnostics June 1999 - December 2003
Roche Diagnostics June 1999 - December 2003
Skills
Six Sigma, Quality System, Medical Devices, FDA, Quality Assurance, Regulatory Affairs, Biotechnology, Process Improvement, Training, Product Development, Regulatory Submissions, Quality Management, Pharmaceutical Industry, Leadership, Validation, Manufacturing, CAPA, Lean Manufacturing, ISO 13485, GMP, Commercialization
Education
Indiana University-Purdue University at Indianapolis 1981 — 1992
Medical Neurobiology
State University of New York College at Plattsburgh 1971 — 1977
BS, Medical Technology
Chaminade 1967 — 1971
Carl Place
Carl Place
Carl Place
Delbert Snyder's Safis-Solutions, LLC Experience September 2006 - January 2007
Job President/Technical Consultant at DayStar Computer Consulting, Inc
Industry Information Technology and Services
Experience
Dietrick Appraisal Services, Inc. January 2005 - Present
DayStar Computer Consulting, Inc October 1997 - Present
hhgregg February 2009 - January 2012
Theoris, Inc. April 2003 - January 2012
Simon Property Group 2012 - 2012
Roche Diagnostics October 2008 - February 2009
Roche Diagnostics November 2006 - October 2008
Safis Solutions, LLC September 2006 - January 2007
Safis Solutions, LLC June 2006 - November 2006
Eli Lilly and Company June 2002 - April 2003
Skills
Databases, SQL, Access, Requirements Gathering, Technical Writing, Visio, Business Analysis, Requirements Analysis, Problem Solving, Testing, Visual Basic, SDLC, Microsoft Office, PL/SQL, Software Development, Application Development, Quality Assurance, Troubleshooting, Documentation, Languages, Software Documentation, Microsoft SQL Server, Database Design, Web Services
Education
Anderson University 1973 — 1977
BA, Computer Science/Math
Dietrick Appraisal Services, Inc. January 2005 - Present
DayStar Computer Consulting, Inc October 1997 - Present
hhgregg February 2009 - January 2012
Theoris, Inc. April 2003 - January 2012
Simon Property Group 2012 - 2012
Roche Diagnostics October 2008 - February 2009
Roche Diagnostics November 2006 - October 2008
Safis Solutions, LLC September 2006 - January 2007
Safis Solutions, LLC June 2006 - November 2006
Eli Lilly and Company June 2002 - April 2003
Skills
Databases, SQL, Access, Requirements Gathering, Technical Writing, Visio, Business Analysis, Requirements Analysis, Problem Solving, Testing, Visual Basic, SDLC, Microsoft Office, PL/SQL, Software Development, Application Development, Quality Assurance, Troubleshooting, Documentation, Languages, Software Documentation, Microsoft SQL Server, Database Design, Web Services
Education
Anderson University 1973 — 1977
BA, Computer Science/Math
Mike Neibler Mike Neibler's Safis-Solutions, LLC Experience September 2005 - August 2008
Job VP Business Development at Algaeon, Inc.
Industry Biotechnology
Experience
Algaeon, Inc. 2012 - Present
Life Science & IT Consulting August 2008 - Present
Indiana Biomedical Entrepreneurs Network 2006 - Present
MedLogistics 2011 - 2012
Xylogenics, Inc. 2008 - 2011
International Society of Automation September 2005 - May 2010
Safis Solutions, LLC September 2005 - August 2008
Flexware Innovation, Inc. 2001 - 2005
Compex 1999 - 2001
Automated Technology Associates 1992 - 1994
Skills
Biotechnology, Lifesciences, Business Strategy, Start-up Ventures, Commercialization, Start-ups, Medical Devices, Strategic Planning, Entrepreneurship, Technology Transfer, Product Development, Business Development, Pharmaceutical Industry, Cross-functional Team..., New Business Development, Business Planning, Project Management, FDA, Process Improvement, Validation, Team Building, Quality System, Venture Capital, R&D
Education
The University of Texas at Austin 1975 — 1976
MBA Program, Operations Management
The Ohio State University 1967 — 1972
BS Chemical Engineering, Minor in Computer Science
Algaeon, Inc. 2012 - Present
Life Science & IT Consulting August 2008 - Present
Indiana Biomedical Entrepreneurs Network 2006 - Present
MedLogistics 2011 - 2012
Xylogenics, Inc. 2008 - 2011
International Society of Automation September 2005 - May 2010
Safis Solutions, LLC September 2005 - August 2008
Flexware Innovation, Inc. 2001 - 2005
Compex 1999 - 2001
Automated Technology Associates 1992 - 1994
Skills
Biotechnology, Lifesciences, Business Strategy, Start-up Ventures, Commercialization, Start-ups, Medical Devices, Strategic Planning, Entrepreneurship, Technology Transfer, Product Development, Business Development, Pharmaceutical Industry, Cross-functional Team..., New Business Development, Business Planning, Project Management, FDA, Process Improvement, Validation, Team Building, Quality System, Venture Capital, R&D
Education
The University of Texas at Austin 1975 — 1976
MBA Program, Operations Management
The Ohio State University 1967 — 1972
BS Chemical Engineering, Minor in Computer Science
Roberta Smithey's Safis-Solutions, LLC Experience 2010 - Present
Job Regulatory Consultant
Industry Pharmaceuticals
Experience
Pearl IRB, LLC 2010 - Present
Safis-Solutions, LLC 2010 - Present
Brentridge Estates Homeowners 2015 - 2015
Brentridge Estates Homeowners 2015 - 2015
Brentridge Estates Homeowners 2015 - 2015
BioCritica, Inc. July 2011 - November 2011
Targanta Therapeutic Corporation 2006 - January 2010
Eli Lilly and Company 2003 - 2006
Skills
Regulatory Affairs, Clinical Trials, Pharmaceutical Industry, Clinical Development, Regulatory Submissions, FDA, eCTD, Drug Development, IND, Clinical Research, Medical Writing, Biotechnology, Biopharmaceuticals, CRO, GCP, Lifesciences, Medical Affairs
Education
University of Indianapolis 1970 — 1976
BA, Chemistry
Pearl IRB, LLC 2010 - Present
Safis-Solutions, LLC 2010 - Present
Brentridge Estates Homeowners 2015 - 2015
Brentridge Estates Homeowners 2015 - 2015
Brentridge Estates Homeowners 2015 - 2015
BioCritica, Inc. July 2011 - November 2011
Targanta Therapeutic Corporation 2006 - January 2010
Eli Lilly and Company 2003 - 2006
Skills
Regulatory Affairs, Clinical Trials, Pharmaceutical Industry, Clinical Development, Regulatory Submissions, FDA, eCTD, Drug Development, IND, Clinical Research, Medical Writing, Biotechnology, Biopharmaceuticals, CRO, GCP, Lifesciences, Medical Affairs
Education
University of Indianapolis 1970 — 1976
BA, Chemistry
Mark Vare's Safis-Solutions, LLC Experience June 2011 - November 2011
Job Consultant at Inmar
Industry Pharmaceuticals
Experience
Inmar November 2011 - Present
MagnetNorth, LLC September 2008 - December 2012
Safis Solutions, LLC June 2011 - November 2011
Propeller Marketing LLC May 2006 - September 2010
Stericycle November 2005 - May 2006
NNC Group, LLC 2003 - November 2005
NNC Group LLC 2001 - 2003
NNC Group LLC 1997 - 2001
VA Medical Center 1992 - 1997
Skills
Regulatory Affairs, Quality Assurance, CAPA, Pharmacists, Consulting, Business Strategy, Business Process..., Food Safety, Drug Safety, Consumer Product Safety, FDA GMP, Recalls, Business Development, Public Speaking, Educational Outreach, FDA, Program Management, Marketing, Strategy
Education
Butler University
BS, Pharmacy
Indiana University Bloomington
BA, Political Science
Inmar November 2011 - Present
MagnetNorth, LLC September 2008 - December 2012
Safis Solutions, LLC June 2011 - November 2011
Propeller Marketing LLC May 2006 - September 2010
Stericycle November 2005 - May 2006
NNC Group, LLC 2003 - November 2005
NNC Group LLC 2001 - 2003
NNC Group LLC 1997 - 2001
VA Medical Center 1992 - 1997
Skills
Regulatory Affairs, Quality Assurance, CAPA, Pharmacists, Consulting, Business Strategy, Business Process..., Food Safety, Drug Safety, Consumer Product Safety, FDA GMP, Recalls, Business Development, Public Speaking, Educational Outreach, FDA, Program Management, Marketing, Strategy
Education
Butler University
BS, Pharmacy
Indiana University Bloomington
BA, Political Science
Benhur Benjamin, M.S. RAC's Safis-Solutions, LLC Experience September 2015 - Present
Job Senior Compliance Advisor at Safis Solutions, LLC
Industry Medical Devices
Experience
Safis Solutions, LLC September 2015 - Present
Beckman Coulter August 2013 - Present
Navigant July 2013 - August 2013
Anson Group October 2010 - July 2013
Eli Lilly May 2002 - September 2010
Taratec Development Corporation December 1998 - March 2002
Bio-Reg Associates May 1996 - June 1997
Skills
Quality Auditing, Process Auditing, Computer System..., Medical Devices, FDA, Change Control, Validation, Quality Systems, Pharmaceuticals, CAPA, GMP, Quality Assurance, Process Improvement, Pharmaceutical Industry, 21 CFR Part 11, GxP, Regulatory Affairs, V&V, ISO 13485, Quality System, IT Infrastructure..., Lifesciences, Sop, Strategy, Regulatory Requirements, Biotechnology, GLP, Technology Transfer, Regulatory Submissions, Clinical Trials, Software Documentation, Commercialization, Quality Control, Clinical Development, GCP, LIMS, R&D, Cross-functional Team..., Business Process, Biopharmaceuticals, Manufacturing, Quality Management, Hardware Diagnostics, Design Control, Oncology, Process Simulation, SharePoint, Clinical Research, ISO, GAMP
Education
Indiana University - Kelley School of Business 2008 — 2013
MBA, General Management
University of Maryland College Park 1994 — 1998
M.S., Bioengineering
Allahabad Agricultural Institute 1984 — 1988
Bachelor of Technology, Agricultural Engineering
Safis Solutions, LLC September 2015 - Present
Beckman Coulter August 2013 - Present
Navigant July 2013 - August 2013
Anson Group October 2010 - July 2013
Eli Lilly May 2002 - September 2010
Taratec Development Corporation December 1998 - March 2002
Bio-Reg Associates May 1996 - June 1997
Skills
Quality Auditing, Process Auditing, Computer System..., Medical Devices, FDA, Change Control, Validation, Quality Systems, Pharmaceuticals, CAPA, GMP, Quality Assurance, Process Improvement, Pharmaceutical Industry, 21 CFR Part 11, GxP, Regulatory Affairs, V&V, ISO 13485, Quality System, IT Infrastructure..., Lifesciences, Sop, Strategy, Regulatory Requirements, Biotechnology, GLP, Technology Transfer, Regulatory Submissions, Clinical Trials, Software Documentation, Commercialization, Quality Control, Clinical Development, GCP, LIMS, R&D, Cross-functional Team..., Business Process, Biopharmaceuticals, Manufacturing, Quality Management, Hardware Diagnostics, Design Control, Oncology, Process Simulation, SharePoint, Clinical Research, ISO, GAMP
Education
Indiana University - Kelley School of Business 2008 — 2013
MBA, General Management
University of Maryland College Park 1994 — 1998
M.S., Bioengineering
Allahabad Agricultural Institute 1984 — 1988
Bachelor of Technology, Agricultural Engineering
Geoffrey Jacks's Safis-Solutions, LLC Experience June 2003 - January 2004
Job Software Quality Assurance at Cardiocom/Medtronic
Industry Medical Devices
Experience
Cardiocom/Medtronic March 2014 - Present
Boston Scientific Corporation January 2005 - March 2014
Theoris, Inc January 2004 - January 2005
Safis Solutions LLC June 2003 - January 2004
The National Manufacturing Technology Center at Indianapolis, Inc September 1997 - June 2003
Winslow Fitzgerald & Gold, LLP June 1997 - November 1997
Skills
Requirements Analysis, SOP, Microsoft Office, V&V, Risk Assessment, Computer System..., Quality System, FDA, 21 CFR Part 11, CAPA, System Testing, User Acceptance Testing, Vendor Audit, Project Management, Black Box Testing, White Box Testing, Software Requirements, Requirements Gathering, Requirements..., Traceability Matrix, Independent..., Risk Based Testing, IQ/OQ/PQ, LIMS, PDM, MES, ISO 13485, Medical Devices, Change Control, Quality Assurance, Software Quality..., Design Control, Software Documentation, Quality Auditing, Process Improvement, Root Cause Analysis, Technical Writing, Test Planning, Validation, Protocol, Quality Control, ISO 14971, Sop, GMP, Quality Management, Testing, QTP
Education
Ball State University 1989 — 1995
BS, General Studies
Cardiocom/Medtronic March 2014 - Present
Boston Scientific Corporation January 2005 - March 2014
Theoris, Inc January 2004 - January 2005
Safis Solutions LLC June 2003 - January 2004
The National Manufacturing Technology Center at Indianapolis, Inc September 1997 - June 2003
Winslow Fitzgerald & Gold, LLP June 1997 - November 1997
Skills
Requirements Analysis, SOP, Microsoft Office, V&V, Risk Assessment, Computer System..., Quality System, FDA, 21 CFR Part 11, CAPA, System Testing, User Acceptance Testing, Vendor Audit, Project Management, Black Box Testing, White Box Testing, Software Requirements, Requirements Gathering, Requirements..., Traceability Matrix, Independent..., Risk Based Testing, IQ/OQ/PQ, LIMS, PDM, MES, ISO 13485, Medical Devices, Change Control, Quality Assurance, Software Quality..., Design Control, Software Documentation, Quality Auditing, Process Improvement, Root Cause Analysis, Technical Writing, Test Planning, Validation, Protocol, Quality Control, ISO 14971, Sop, GMP, Quality Management, Testing, QTP
Education
Ball State University 1989 — 1995
BS, General Studies
L. I. Rapkin L. I. Rapkin's Safis-Solutions, LLC Experience 2010 - 2011
Job SQA by Day, Yoga by Night
Industry Information Technology and Services
Experience
Schoen Family Law 2013 - Present
Sogeti November 2011 - Present
Self - Employed November 2005 - Present
International Conference on Software Quality 2014 - 2015
International Conference on Software Quality 2014 - 2015
Safis Solutions, LLC 2010 - 2011
Eli Lilly and Company 2004 - 2010
Theoris 2004 - 2010
CREW Technical Services 1998 - 2000
eCatalogs 1998 - 1999
Skills
Technical Writing, Agile Testing, Business Analysis, Computer System..., Regulatory Documentation, Requirements Management, Requirements Gathering, Requirements Analysis, Manual Testing, User Acceptance Testing, System Testing, ITIL, Yoga, Test Planning, Test Management, Software Quality..., Software Documentation, Integration, Technical Documentation, SharePoint, Visio, SDLC, 21 CFR Part 11, Quality Assurance, Testing, Microsoft SQL Server, MS Project, Agile Project Management, Process Improvement, Agile Methodologies, PMP, Business Process, Software Development, Databases, Cross-functional Team..., PMO, Project Portfolio..., Scrum, Business Intelligence, IT Strategy, Resource Management, Business Process..., Business Requirements, Vendor Management, Project Management, Consulting, Information Technology, Program Management, IT Management
Education
YogaFit 2004 — 2012
RYT-200, Yoga Instructor
Indiana University Bloomington 1990 — 1992
Bachelor of Arts, Television Production, East Asian Studies
San Francisco State University 1989 — 1990
N/A, Film
Monta Vista High School 1985 — 1987
Diploma, General Studies
Schoen Family Law 2013 - Present
Sogeti November 2011 - Present
Self - Employed November 2005 - Present
International Conference on Software Quality 2014 - 2015
International Conference on Software Quality 2014 - 2015
Safis Solutions, LLC 2010 - 2011
Eli Lilly and Company 2004 - 2010
Theoris 2004 - 2010
CREW Technical Services 1998 - 2000
eCatalogs 1998 - 1999
Skills
Technical Writing, Agile Testing, Business Analysis, Computer System..., Regulatory Documentation, Requirements Management, Requirements Gathering, Requirements Analysis, Manual Testing, User Acceptance Testing, System Testing, ITIL, Yoga, Test Planning, Test Management, Software Quality..., Software Documentation, Integration, Technical Documentation, SharePoint, Visio, SDLC, 21 CFR Part 11, Quality Assurance, Testing, Microsoft SQL Server, MS Project, Agile Project Management, Process Improvement, Agile Methodologies, PMP, Business Process, Software Development, Databases, Cross-functional Team..., PMO, Project Portfolio..., Scrum, Business Intelligence, IT Strategy, Resource Management, Business Process..., Business Requirements, Vendor Management, Project Management, Consulting, Information Technology, Program Management, IT Management
Education
YogaFit 2004 — 2012
RYT-200, Yoga Instructor
Indiana University Bloomington 1990 — 1992
Bachelor of Arts, Television Production, East Asian Studies
San Francisco State University 1989 — 1990
N/A, Film
Monta Vista High School 1985 — 1987
Diploma, General Studies
Lance Wenck, MBA's Safis-Solutions, LLC Experience 2015 - Present
Job Director, Business Development at Safis Solutions, LLC
Industry Biotechnology
Experience
Safis Solutions, LLC 2015 - Present
Kelly Scientific Resources 2015 - 2015
Vesta Pharmaceuticals, Inc. dBA Vesta Nutra 2014 - 2015
BioStorage Technologies, Inc. 2011 - 2013
ITT Educational Services, Inc. 2010 - 2011
Meridian Outsourcing 2009 - 2010
Thermo Fisher Scientific 2006 - 2009
Thermo Fisher Scientific 2003 - 2006
Thermo Fisher Scientific 2002 - 2003
Seradyn 1999 - 2002
Skills
Management, Manufacturing, Operations Management, Program Management, FDA, Process Improvement, Biotechnology, Inventory Management, Validation, Lifesciences, GMP, Medical Devices, Microsoft Excel, Pharmaceutical Industry, Leadership, Lead Generation, Quality Assurance, ERP, Supply Chain, Business Development, Project Management, Product Development, Six Sigma, Change Management, Cross-functional Team..., Budgets, Contract Negotiation, Software Documentation, Forecasting, Supply Chain Management, Continuous Improvement, Quality System, Sales, Training, Start-ups, Competitive Analysis, Life Sciences
Education
Indiana University - Kelley School of Business 2001 — 2003
MBA, Business Administration
Indiana University-Purdue University at Indianapolis 1994 — 1998
BS, Chemistry
Safis Solutions, LLC 2015 - Present
Kelly Scientific Resources 2015 - 2015
Vesta Pharmaceuticals, Inc. dBA Vesta Nutra 2014 - 2015
BioStorage Technologies, Inc. 2011 - 2013
ITT Educational Services, Inc. 2010 - 2011
Meridian Outsourcing 2009 - 2010
Thermo Fisher Scientific 2006 - 2009
Thermo Fisher Scientific 2003 - 2006
Thermo Fisher Scientific 2002 - 2003
Seradyn 1999 - 2002
Skills
Management, Manufacturing, Operations Management, Program Management, FDA, Process Improvement, Biotechnology, Inventory Management, Validation, Lifesciences, GMP, Medical Devices, Microsoft Excel, Pharmaceutical Industry, Leadership, Lead Generation, Quality Assurance, ERP, Supply Chain, Business Development, Project Management, Product Development, Six Sigma, Change Management, Cross-functional Team..., Budgets, Contract Negotiation, Software Documentation, Forecasting, Supply Chain Management, Continuous Improvement, Quality System, Sales, Training, Start-ups, Competitive Analysis, Life Sciences
Education
Indiana University - Kelley School of Business 2001 — 2003
MBA, Business Administration
Indiana University-Purdue University at Indianapolis 1994 — 1998
BS, Chemistry
Todd Swift, PMP's Safis-Solutions, LLC Experience 2007 - December 2013
Job Project Manager, PMO at DEFENDER
Industry Information Technology and Services
Experience
DEFENDER March 2014 - Present
MPUG January 2014 - Present
Guilford Group, LLC November 2005 - March 2014
Safis Solutions, LLC 2007 - December 2013
Information Systems Experts November 2005 - February 2010
International Society of Automation (Indianapolis Section) 2004 - 2009
International Society of Automation (Indianapolis Section) 2005 - 2006
Society of Manufacturing Engineers - Indianapolis Chapter 2005 - 2006
IndyPASS 2005 - 2006
Pilkington 2005 - 2005
Skills
Software Development, SharePoint, Technical Leadership, Project Management, C#, Microsoft SQL Server, Microsoft Office..., Technical Writing, PMP, MCSD, Consulting, MS Project, CQIA, Java, Agile Methodologies, Web Services, SDLC, Requirements Analysis, Databases, Management, Microsoft Project, Process Improvement, Leadership
Education
Purdue University 1999 — 2002
Computer Integrated Manufacturing Technology, Technology
DEFENDER March 2014 - Present
MPUG January 2014 - Present
Guilford Group, LLC November 2005 - March 2014
Safis Solutions, LLC 2007 - December 2013
Information Systems Experts November 2005 - February 2010
International Society of Automation (Indianapolis Section) 2004 - 2009
International Society of Automation (Indianapolis Section) 2005 - 2006
Society of Manufacturing Engineers - Indianapolis Chapter 2005 - 2006
IndyPASS 2005 - 2006
Pilkington 2005 - 2005
Skills
Software Development, SharePoint, Technical Leadership, Project Management, C#, Microsoft SQL Server, Microsoft Office..., Technical Writing, PMP, MCSD, Consulting, MS Project, CQIA, Java, Agile Methodologies, Web Services, SDLC, Requirements Analysis, Databases, Management, Microsoft Project, Process Improvement, Leadership
Education
Purdue University 1999 — 2002
Computer Integrated Manufacturing Technology, Technology
Julia Oelker's Safis-Solutions, LLC Experience 2004 - 2005
Job Regulatory Compliance and Software Quality Assurance
Industry Computer Software
Experience
KAR Auction Services (ADESA) July 2010 - Present
Computer Task Group October 2008 - April 2010
Smart IT Staffing/RND Group July 2007 - May 2008
CH2M HILL/Lockwood Greene Engineering June 2005 - November 2006
Safis Solutions, LLC 2004 - 2005
Made2Manage Systems (now Aptean) 1997 - 2003
Skills
Process Improvement, FDA, SDLC, Quality Center, Software Quality..., Testing, Computer System..., Program Management, Validation, Quality Assurance, Regression Testing, Analysis, Software Documentation, Troubleshooting, Agile Methodologies
Education
Indiana University Bloomington
M.S.Ed, Instructional Technology, 3.8/4.0
KAR Auction Services (ADESA) July 2010 - Present
Computer Task Group October 2008 - April 2010
Smart IT Staffing/RND Group July 2007 - May 2008
CH2M HILL/Lockwood Greene Engineering June 2005 - November 2006
Safis Solutions, LLC 2004 - 2005
Made2Manage Systems (now Aptean) 1997 - 2003
Skills
Process Improvement, FDA, SDLC, Quality Center, Software Quality..., Testing, Computer System..., Program Management, Validation, Quality Assurance, Regression Testing, Analysis, Software Documentation, Troubleshooting, Agile Methodologies
Education
Indiana University Bloomington
M.S.Ed, Instructional Technology, 3.8/4.0
John Lockwood's Safis-Solutions, LLC Experience May 2008 - August 2014
Job Director, Quality Assurance and Regulatory Affairs
Industry Medical Devices
Experience
Pearl Pathways May 2015 - Present
AMD LASERS, an AMD GROUP LLC company August 2014 - May 2015
Safis Solutions, LLC May 2008 - August 2014
Roche Diagnostics August 2001 - May 2008
Abbott Diagnostics April 1994 - August 2001
Skills
Quality System, Quality Auditing, FDA, CAPA, Medical Devices, GMP, Validation, Regulatory Affairs, ISO 13485, Design Control, Quality Assurance, Change Control, 21 CFR Part 11, Quality Management, Root Cause Analysis, FDA GMP, Complaint Management, ISO, IVD, Quality Control, ISO 14971, CE marking, Regulatory Submissions, Biopharmaceuticals, Commercialization, Biotechnology, V&V, Lifesciences, Cross-functional Team..., Computer System..., Technology Transfer, Regulatory Requirements, GxP, Pharmaceutical Industry, Sop, Clinical Development, GLP, Clinical Trials, LIMS, Product Development, Supplier Quality, Drug Development, Aseptic Processing, R&D, Manufacturing, 21 CFR, IND, NDA, GCP, Pharmaceutics
Education
University of Illinois at Urbana-Champaign 1989 — 1993
BS, Chemistry
Accademia Qualitas CMDCAS training
Pearl Pathways May 2015 - Present
AMD LASERS, an AMD GROUP LLC company August 2014 - May 2015
Safis Solutions, LLC May 2008 - August 2014
Roche Diagnostics August 2001 - May 2008
Abbott Diagnostics April 1994 - August 2001
Skills
Quality System, Quality Auditing, FDA, CAPA, Medical Devices, GMP, Validation, Regulatory Affairs, ISO 13485, Design Control, Quality Assurance, Change Control, 21 CFR Part 11, Quality Management, Root Cause Analysis, FDA GMP, Complaint Management, ISO, IVD, Quality Control, ISO 14971, CE marking, Regulatory Submissions, Biopharmaceuticals, Commercialization, Biotechnology, V&V, Lifesciences, Cross-functional Team..., Computer System..., Technology Transfer, Regulatory Requirements, GxP, Pharmaceutical Industry, Sop, Clinical Development, GLP, Clinical Trials, LIMS, Product Development, Supplier Quality, Drug Development, Aseptic Processing, R&D, Manufacturing, 21 CFR, IND, NDA, GCP, Pharmaceutics
Education
University of Illinois at Urbana-Champaign 1989 — 1993
BS, Chemistry
Accademia Qualitas CMDCAS training
Dawn Fernandes's Safis-Solutions, LLC Experience January 2014 - Present
Job Director, Regulatory & Compliance Services at Safis Solutions, LLC
Industry Pharmaceuticals
Experience
Safis Solutions, LLC January 2014 - Present
BioConvergence LLC May 2012 - October 2013
Safis Solutions, LLC January 2009 - May 2012
Eli Lilly September 2002 - January 2009
Seradyn June 1997 - September 2002
Skills
Compliance, Auditing, Pharmaceuticals, GMP, FDA, Pharmaceutical..., cGMP, Outsourcing Management, Medical Devices, Quality Assurance, Quality Systems, Pharmaceutical Industry, Quality System, Validation, Product Development, Quality Control, Analytical Chemistry, GxP, ISO, Change Control, Drug Development, Regulatory Affairs, Sop, Computer System..., GLP, CAPA, Regulatory Submissions, Pharmaceutics, Regulatory Requirements, Cleaning Validation, FDA GMP, V&V, Quality Auditing, Biotechnology, Aseptic Processing, Technology Transfer, Biopharmaceuticals, Third Party..., SOP, Leadership, PPC, Product Complaints, Design Control
Education
Indiana University-Purdue University at Indianapolis 1993 — 2002
BA, Chemistry
Indiana University Bloomington 1984 — 1988
BS, AMID
Safis Solutions, LLC January 2014 - Present
BioConvergence LLC May 2012 - October 2013
Safis Solutions, LLC January 2009 - May 2012
Eli Lilly September 2002 - January 2009
Seradyn June 1997 - September 2002
Skills
Compliance, Auditing, Pharmaceuticals, GMP, FDA, Pharmaceutical..., cGMP, Outsourcing Management, Medical Devices, Quality Assurance, Quality Systems, Pharmaceutical Industry, Quality System, Validation, Product Development, Quality Control, Analytical Chemistry, GxP, ISO, Change Control, Drug Development, Regulatory Affairs, Sop, Computer System..., GLP, CAPA, Regulatory Submissions, Pharmaceutics, Regulatory Requirements, Cleaning Validation, FDA GMP, V&V, Quality Auditing, Biotechnology, Aseptic Processing, Technology Transfer, Biopharmaceuticals, Third Party..., SOP, Leadership, PPC, Product Complaints, Design Control
Education
Indiana University-Purdue University at Indianapolis 1993 — 2002
BA, Chemistry
Indiana University Bloomington 1984 — 1988
BS, AMID
Gretchen Parker, PhD, RAC's Safis-Solutions, LLC Experience January 2007 - September 2009
Job Regulatory Compliance Advisor at Pearl Pathways
Industry Pharmaceuticals
Experience
Pearl Pathways February 2013 - Present
Pearl IRB, LLC January 2011 - Present
Pat Tillman Foundation 2009 - Present
OptumInsight October 2009 - February 2013
Safis Solutions, LLC January 2007 - September 2009
Indiana University School of Medicine 2002 - 2006
Skills
Grant Writing, Regulatory Affairs, Scientific Writing, Clinical Trials, Clinical Research, Community Outreach, Research Ethics, Basic Research
Education
Purdue University 1998 — 2002
PhD, Molecular Endocrinology Biochemistry
Indiana University Bloomington 1985 — 1989
BA, Business and Telecommunications
Pearl Pathways February 2013 - Present
Pearl IRB, LLC January 2011 - Present
Pat Tillman Foundation 2009 - Present
OptumInsight October 2009 - February 2013
Safis Solutions, LLC January 2007 - September 2009
Indiana University School of Medicine 2002 - 2006
Skills
Grant Writing, Regulatory Affairs, Scientific Writing, Clinical Trials, Clinical Research, Community Outreach, Research Ethics, Basic Research
Education
Purdue University 1998 — 2002
PhD, Molecular Endocrinology Biochemistry
Indiana University Bloomington 1985 — 1989
BA, Business and Telecommunications
Brendon Burke's Safis-Solutions, LLC Experience May 2013 - August 2013
Job Student at Lipscomb University
Industry
Experience
Safis Solutions, LLC May 2013 - August 2013
Lipscomb University January 2012 - May 2013
Skills
Molecular Biology
Education
Indiana University School of Medicine 2015 — 2019
Lipscomb University 2011 — 2015
Bachelor of Science (BS), Biochemistry and Biology
Safis Solutions, LLC May 2013 - August 2013
Lipscomb University January 2012 - May 2013
Skills
Molecular Biology
Education
Indiana University School of Medicine 2015 — 2019
Lipscomb University 2011 — 2015
Bachelor of Science (BS), Biochemistry and Biology