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Michelle Whipple Location
Ashburnham, MA, US
Michelle Whipple Work
2020 -now Head of Quality Assurance @
2018 -2020 Head of Quality Systems and Compliance @ Rentschler Biopharma SE (formerly Ipsen, Baxter, Baxalta, Shire)
2014 -2018 Head of US Quality Validation @ Baxter International Inc./ Baxalta/ Shire
2011 -2014 Validation Manager @
2007 -2011 Associate Director, QA Validation @
1999 -2007 Manager QA Validation @
1995 -1999 Validation Engineer @
Michelle Whipple Education
Worcester Polytechnic Institute
MS (Chemical Engineering)
1993-1995
University of Massachusetts Amherst
BS (Chemical Engineering)
1988-1992
Michelle Whipple Skills
Computer System Validation
Validation
CAPA
21 CFR Part 11
GMP
GxP
V&V
Change Control
FDA
Aseptic Processing
Pharmaceutical Industry
Cleaning Validation
Biotechnology
Sop
GAMP
Quality Assurance
CIP
Equipment Qualification
cGMP practices
Lifesciences
Quality Control
Regulatory Affairs
Purification
Calibration
Pharmaceutical Manufacturing
Aseptic Technique
Chromatography
HPLC
R&D
Regulatory Submissions
GCP
UV/Vis
USP
Analytical Chemistry
GLP
Regulatory Requirements
ISO 13485
Pharmaceutics
Sterilization
Quality Auditing
Filtration
Contract Manufacturing
MES
Deviations
Quality by Design
Process Simulation
Medical Devices
Consent Decree
FDA GMP
CQA
Medical Imaging
Project Management
Marketing
Manufacturing Engineer
Management
Testing
Manufacturing
Michelle Whipple Summary
Michelle Whipple, based in Ashburnham, MA, US, is currently a Head of Quality Assurance at scPharmaceuticals. Michelle Whipple brings experience from previous roles at Rentschler Biopharma SE (formerly Ipsen, Baxter, Baxalta, Shire), Baxter International Inc./ Baxalta/ Shire, Ipsen and Bristol-Myers Squibb. Michelle Whipple holds a 1993 - 1995 MS in Chemical Engineering @ Worcester Polytechnic Institute. With a robust skill set that includes Computer System Validation, Validation, CAPA, 21 CFR Part 11, GMP and more. Michelle Whipple has 3 emails and 1 mobile phone numbers on RocketReach.
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