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James Cole Location
Boston, MA, US
James Cole Work
Delivery Specialist @ (October 2023 - Present)
President @ Alliance Quality Consulting (January 2019 - Present)
Senior Director Quality Compliance @ EQRx (Bought by RevMed) (February 2023 - January 2024)
Senior Director Quality Systems and Clinical Quality Assurance @ (September 2019 - May 2022)
Director of Supplier Quality Management @ (June 2017 - August 2019)
Sr. Advisor, Factory Compliance @ (August 2016 - May 2017)
Associate Director QA Operations and Quality Systems @ (February 2009 - July 2016)
QA Operations and Investigations Manager @ (January 2003 - January 2009)
QA Manager @ Harvest Technology Medical Device (June 2007 - June 2008)
QA Manager @ (November 2001 - March 2003)
Quality Assurance and Research Development Manager @ Franklin Mushroom Farm (bankruptcy) (May 2000 - November 2001)
Quality Assurance Specialist and Research Development @ (September 1998 - April 2000)
Quality Assurance and Research Development Manager @ E. Rosen Candy Factory (bankruptcy) (March 1998 - August 1998)
Quality Assurance Auditor @ (October 1997 - July 1998)
Communications Line Chief @ (July 1991 - July 1997)
James Cole Education
University of Rhode Island
BS (Food Science)
1995-1997
James Cole Skills
Quality System
CAPA
GMP
Quality Operations
Deviation Management
Strategic Planning
Batch Records
Batch Release
Training Management
Document Processing
Investigation Management
Management Review
Risk Management
Metrics Reporting
Performance Dashboards
KPI implementation
Quality Management
Quality Auditing
Change Control
Product Complaints
Clinical Quality
Medical Devices
Biotechnology Industry
Pharmaceutics
pest control
Biopharmaceuticals
21 CFR Part 11
Biotechnology
Validation
SOP
FDA
Pharmaceutical Industry
Technology Transfer
Corrective and Preventive Action (CAPA)
Corrective And Preventive Action Capa
U.S. Food And Drug Administration Fda
Standard Operating Procedure Sop
u.s. Food and Drug Administration
Corrective and Preventive Action
Standard Operating Procedure
James Cole Summary
James Cole, based in Boston, MA, US, is currently a Delivery Specialist at Meals on Wheels of Rhode Island. James Cole brings experience from previous roles at Alliance Quality Consulting, EQRx (Bought by RevMed), Kiniksa Pharmaceuticals and Alnylam Pharmaceuticals. James Cole holds a 1995 - 1997 BS in Food Science @ University of Rhode Island. With a robust skill set that includes Quality System, CAPA, GMP, Quality Operations, Deviation Management and more. James Cole has 2 emails and 1 mobile phone numbers on RocketReach.
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