Director, Microbiology and Sterility Assurance @ (March 2025 - August 2025)
Associate Director, Microbiology and Sterility Assurance @ (February 2025 - March 2025)
Sterility Assurance, Associate Director @ (January 2024 - February 2025)
QC Manager Compliance and Continuous Improvement @ (May 2022 - December 2023)
Transformation Change Lead @ (June 2021 - May 2022)
Manufacturing Quality Specialist, Upstream @ (September 2020 - May 2022)
Supervisor, QC Environmental Monitoring @ (November 2018 - September 2020)
Microbiology Manager @ (March 2018 - November 2018)
Microbiology Supervisor @ (July 2017 - March 2018)
Microbiology Lead, Training Coordinator @ (February 2017 - July 2017)
Microbiology Production Analyst III, Lead @ (July 2015 - February 2017)
Microbiologist, Analyst 2 @ (December 2013 - June 2015)
Microbiologist, Analyst 1 @ (September 2013 - December 2013)
Pharmacy Technician @ (January 2007 - January 2013)
Caroline Strain Education
Fontbonne University
Bachelor of Science (BS) (Biology, Concentration in Physiology)
2010-2012
University of Health Sciences and Pharmacy in St. Louis
PharmD Candidate (Pharmacy)
2005-2010
Caroline Strain Skills
Good Laboratory Practice (GLP)
Management
Aseptic Technique
Influence Operations
ICH
Strategy
Corrective Actions
OOS
Sterility Assurance
Contamination Control
Quality Control
Cross-functional Team Leadership
GMP
SOP
Life Sciences
Microbiology
Biotechnology
Pharmaceutical Industry
Sterility
Team Leadership
Organizational Effectiveness
Test Validation
Microbial identification
Analytical Reasoning
Analytic Problem Solving
Equipment Qualification
Data Analysis
Drug Metabolism
Drug Interactions
Drug compounding
Protocol Development
Validation
Biochemistry
FDA
Leadership
TapRoot
Environmental Compliance
Process Quality Improvement
cGMP practices
Endotoxin
Method Development
Corrective and Preventive Action (CAPA)
U.S. Pharmacopeia (USP)
Personal Development
Caroline Strain Summary
Caroline Strain, based in St. Louis, MO, US, is currently a Sr. Manager, Operations - Manufacturing Compliance at Thermo Fisher Scientific. Caroline Strain brings experience from previous roles at Charles River Laboratories and Thermo Fisher Scientific. Caroline Strain holds a 2010 - 2012 Bachelor of Science (BS) in Biology, Concentration in Physiology @ Fontbonne University. With a robust skill set that includes Good Laboratory Practice (GLP), Management, Aseptic Technique, Influence Operations, ICH and more. Caroline Strain has 3 mobile phone numbers on RocketReach.
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