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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