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James Cole Location
Boston, MA, US
James Cole Work
2023 -now Delivery Specialist @
2019 -now President @ Alliance Quality Consulting
2023 -2024 Senior Director Quality Compliance @ EQRx (Bought by RevMed)
2019 -2022 Senior Director Quality Systems and Clinical Quality Assurance @
2017 -2019 Director of Supplier Quality Management @
2016 -2017 Sr. Advisor, Factory Compliance @
2009 -2016 Associate Director QA Operations and Quality Systems @
2003 -2009 QA Operations and Investigations Manager @
2007 -2008 QA Manager @ Harvest Technology Medical Device
2001 -2003 QA Manager @
2000 -2001 Quality Assurance and Research Development Manager @ Franklin Mushroom Farm (bankruptcy)
1998 -2000 Quality Assurance Specialist and Research Development @
1998 -1998 Quality Assurance and Research Development Manager @ E. Rosen Candy Factory (bankruptcy)
1997 -1998 Quality Assurance Auditor @
1991 -1997 Communications Line Chief @
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 on RocketReach.
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