Quality Analyst

Job Summary

A company is looking for a Quality Analyst to manage quality events and CAPAs related to study conduct and data quality.

Key Responsibilities

• Generate quality metrics and assist in process improvement for the Quality Unit
• Manage CAPA responses for internal and external audits, ensuring timely corrective actions
• Develop and document new procedures, training materials, and updates to Standard Operating Procedures

Required Qualifications and Education

• Bachelor's Degree in a Scientific or Technical Field
• 2 to 5 years of experience in a Quality Assurance role within an FDA regulated industry
• Knowledge of 21CFR Part 11, 21 CFR 820.20, ISO 9001/13485 preferred
• Experience with Quality Management Systems and CAPA preferred
• Knowledge of GDP and GCP required