Summary
Skilled quality assurance auditor with 5 years of experience in control plans, internal audits, and regulatory compliance. Strong analytical skills and a proven ability to build relationships across teams to drive quality improvements.
Experience
- Led 15 internal audits, identifying and resolving 30 compliance issues in line with FDA and ISO standards.
- Administered document control processes, reducing approval cycle time by 25%.
- Assisted study teams in developing CAPA plans, cutting repeat audit findings by 40%.
- Built strong partnerships with 4 business units to improve quality control processes.
- Supported production part approval process, helping launch 3 new product lines with zero major audit findings.
- Maintained control plans and quality documentation for 5 manufacturing lines.
Education
Courses
- ASQ Certified Quality Auditor (CQA), ASQ