Regulatory Quality Assurance Analyst

Job Summary

A company is looking for a Regulatory Quality Assurance Analyst.

Key Responsibilities

• Execute day-to-day Quality Assurance activities to ensure compliance with regulatory requirements and internal quality standards
• Manage complaint handling activities, including investigation and documentation
• Support internal audits, regulatory inspections, and identify process inefficiencies for improvement initiatives

Required Qualifications, Training, and Education

• Associate degree or equivalent experience in a related field; bachelor's degree preferred
• Minimum of 1-3 years of related experience in quality, supply chain management, or pharmaceuticals
• Working knowledge of Drug Supply Chain Security Act (DSCSA)
• Certifications such as Certified Quality Professional (CQE, CQA) or Lean Six Sigma are a plus
• Experience in producing clear and compliant documentation