Rebecca Thaxton
Florence,KY
Summary
Regulatory Affairs & Quality Compliance Specialist with over 9 years in GMP-regulated pharmaceutical environments, focusing on regulatory compliance and audit readiness. Delivered multi-site GMP alignment, authored controlled documentation, and ensured inspection readiness through quality systems. Expertise in CMC activities, stability data management, compendial testing, and compliance frameworks with proficiency in Veeva, TrackWise, LIMS, and SAP.
Overview
5
5
years of professional experience
Work History
Quality Control Scientist
ADM
Erlanger, KY
04.2025 - 03.2026
- Designed and executed internal GMP and ISO 9001 audit programs, strengthening inspection preparedness and documentation defensibility
- Led GMP compliance enhancements across four laboratories, aligning operations with regulatory expectations and improving audit readiness
- Owned deviation investigations, conducted root cause analysis (RCA), and implemented CAPA strategies to prevent recurrence
- Supported regulatory compliance through oversight of batch record review, batch approvals, and controlled documentation practices
- Authored and revised SOPs to align with GMP requirements and data integrity (ALCOA+) standards
- Executed stability program with precise tracking and documentation, ensuring compliance with regulatory expectations
- Collaborated with quality, manufacturing, and compliance teams to ensure alignment with regulatory requirements and enhance operational effectiveness
Scientist I
Thermo Fisher Scientific
Cincinnati, OH
07.2021 - 02.2025
- Supported GMP-regulated operations through execution of compendial and stability testing aligned with USP and regulatory standards
- Performed method execution and verification using validated analytical techniques in accordance with GMP and regulatory expectations
- Maintained strict adherence to data integrity principles (ALCOA+) across all laboratory and documentation activities
- Oversaw DEA-controlled sample lifecycle, managing stability tracking, inventory control, and ensuring documentation compliance
- Ensured audit readiness by maintaining accurate laboratory documentation and facilitating internal/external audits
- Supported SOP adherence and led continuous improvement initiatives within regulated laboratory environments
Education
Bachelor of Science - Biology
Mount St. Joseph University
Cincinnati, OH12-2020
Skills
Regulatory / Quality
- Regulatory compliance
- GMP / GLP
- Data integrity
- ALCOA principles
- Audit readiness
- SOP development
- Document control
- Quality systems
- Deviation management
- CAPA management
- Root cause analysis
- Risk assessment
- Inspection readiness
- CFR 21
- ISO standards
- USP standards
- Compendial testing
- USP monographs
- DEA compliance
- Stability testing
- Stability inventory
- Acceptance sampling
- Food safety
- HACCP systems
- FSSC 22000
- FSQA programs
- Environmental monitoring
- Analytical chemistry
- Wet chemistry
- Sample preparation
- Solution preparation
- Method validation
- Method transfer
- Chromatography
- TLC analysis
- Spectroscopy
- UV testing
- NIR spectroscopy
- IR spectroscopy
- Colorimetric analysis
- Combustion testing
- Moisture analysis
- Loss on drying
- Evaporation techniques
- Rotovap operation
- Karl Fischer
- Volumetric KF
- Coulometric KF
- Acid-base titration
- Redox titration
- Salt titration
- Potentiometric titration
- HPLC analysis
- GC analysis
- LC analysis
- Refractometry
- pH measurement
- Brix measurement
- Specific gravity
- Density testing
- Viscosity testing
- Appearance testing
- Hardness testing
- Disintegration testing
- Turbidity testing
- PCR techniques
- Gel electrophoresis
- Gram staining
- Aseptic technique
- Tissue culture
- DNA extraction
- Microscopy
- Replica plating
- Animal studies
- Gene knockout
- Tail biopsies
- Centrifugation
- Distillation
- Environmental testing
- Laboratory compliance
- LIMS systems
- TrackWise system
- Veeva systems
- SAP systems
- ERP systems
- Data trending
- Statistical analysis
- Excel proficiency
- Process validation
- Equipment qualification
- IQ OQ PQ
- Spreadsheet validation
- GAMP5 framework
- Batch review
- Change control
- Training development
- Cross-functional collaboration
- Stakeholder communication
- Regulatory interpretation
- Compliance strategy
- Supplier quality
- Continuous improvement
- Right-first-time
- Time management
- Problem solving
- Attention detail
Systems And Technical Tools
- EQMS: TrackWise, Veeva
- LIMS: SampleManager, LabWare
- ERP: SAP, AS400
- Analytical Systems: Empower, LabSolutions, OMNIC, Cary WinUV, Metrohm, Mettler Toledo
- Documentation & Collaboration: Microsoft Office, Google Workspace, SharePoint
Additional Qualifications
- Extensive experience supporting GMP, GLP, and GDP regulated environments
- Strong working knowledge of USP compendial standards and pharmaceutical testing requirements
- Demonstrated ability to translate laboratory operations into compliant, audit-ready documentation
- Proven contributor to cross-functional quality and regulatory initiatives
Accomplishments
Intensity Award (2022)
Timeline
Quality Control Scientist
ADM
04.2025 - 03.2026
Scientist I
Thermo Fisher Scientific
07.2021 - 02.2025
Bachelor of Science - Biology
Mount St. Joseph University