Sydnee Alexander
Chicago ,USA
Summary
Dynamic regulatory compliance and quality assurance professional with a proven track record of
enhancing operational efficiency across diverse sectors. Expertise in risk assessment, crossfunctional
collaboration, and strategic project management has driven significant quality
improvements and ensured rigorous regulatory adherence. Recognized for fostering a culture of
excellence through effective leadership and a commitment to people-first principles.
Overview
7
7
years of professional experience
Work History
FSQA Scientist
Ocean Spray Cranberries
07.2022 - Current
- Lead regulatory compliance initiatives, ensuring adherence to industry standards
- Analyse complex scientific data to support product development and market entry strategies
- Develop novel approaches to regulatory challenges, streamlining approval processes
- Collaborate with cross-functional teams to implement cutting-edge scientific methodologies
- Drive regulatory approvals for new products, significantly reducing time-to-market
- Optimize documentation processes, enhancing efficiency and accuracy in submissions
- Foster strong relationships with regulatory bodies and industry partners
- Contribute expertise to multidisciplinary teams, ensuring alignment of scientific and regulatory objectives
- Meticulously review and interpret complex regulatory guidelines
- Ensure precise documentation and reporting, maintaining the highest standards of scientific integrity and compliance
Quality & Regulatory Manager
Testa Produce
08.2019 - 02.2022
- Streamlined regulatory processes, reducing compliance delays efficiently
- Implemented quality control measures, boosting product consistency
- Led cross-functional training, enhancing staff regulatory skills
- Managed multi-site quality operations, ensuring regulatory adherence
Quality Supervisor - Dietary Supplements
Ferrara Candy Company
09.2017 - 07.2019
- Manage quality control for supplements, ensuring FDA compliance and industry standards
- Led teams to boost production efficiency, cutting waste and enhancing product consistency
- Introduced new quality control methods, improving inspection processes with advanced technology
- Updated SOPs to meet changing regulations, conducting audits to uphold quality standards
- Built supplier partnerships for raw material quality, enhancing team knowledge on regulations
- Directed QA to enhance compliance, improving product quality across sites
Education
Masters - Regulatory Compliance
Johns Hopkins University
12.2021
Bachelors Degree - Biology
Dillard University
New Orleans, LA05.2017
Skills
- Project Management
- Data Analysis
- Risk Assessment
- Regulatory Compliance
- Quality Improvement
- Process Optimization
- Team Leadership
- Regulatory Strategy
- Audit Management
- Supplier Relations
- Training Development
- Cross-Functional Collaboration
- Quality Assurance
- Inspection Technology
- Process Improvement
- Change Management
- Regulatory Affairs
- Compliance Training
- Strategic Planning
- Operational Excellence
- Quality Control
- Regulatory Audit
- Product Development
- Process Validation
- Technical Writing
- Compliance Monitoring
- Quality Certification
- Risk Management
- Risk Mitigation
- Supplier Management
- Technical Documentation
- Process Design
Timeline
FSQA Scientist
Ocean Spray Cranberries
07.2022 - Current
Quality & Regulatory Manager
Testa Produce
08.2019 - 02.2022
Quality Supervisor - Dietary Supplements
Ferrara Candy Company
09.2017 - 07.2019
Masters - Regulatory Compliance
Johns Hopkins University
Bachelors Degree - Biology
Dillard University
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