Senior QA Specialist

Job Summary

A company is looking for a Senior QA Specialist to drive compliance and quality across biometric services and computer systems.

Key Responsibilities

• Conduct internal and vendor audits, review Trial Master Files, and report audit findings
• Maintain and develop Quality Management System documents, ensuring compliance with regulations
• Collaborate on computer system validation and ensure systems meet regulatory requirements

Required Qualifications

• Bachelor's degree in life sciences, computer science, or a related field
• Minimum of 5 years of QA experience in clinical research or regulated software environments
• Strong knowledge of GxP, ICH-GCP, and 21 CFR Part 11
• Proven experience in conducting audits and managing CAPAs
• Preferred experience with eClinical or biometric services and familiarity with electronic QMS platforms