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Quality Analyst

7/4/2025

Remote

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

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