Summary
Quality assurance specialist with 6 years of experience in documentation review, regulatory compliance, and risk management. Skilled in analyzing audit findings, addressing deviations, and driving continuous improvement in GMP environments.
Experience
- Analyzed audit findings and implemented corrective actions, reducing deviations by 18% in one year.
- Led documentation review for 2,000+ records, ensuring compliance with 21 CFR 11 and GMP standards.
- Coordinated batch record review and complaint investigation initiation, improving closure rates by 22%.
- Supported licensing and certification reviews, contributing to successful audit outcomes.
- Assisted in data integrity compliance and procedures implementation, resulting in zero audit findings.
- Managed document change requests, reducing processing time by 25%.
- Trained 15+ staff on documentation best practices.
Education
Courses
- Certified Auditor, ASQ