Senior IT Quality Control Specialist

Job Summary

A company is looking for a Senior IT Quality Control Specialist - CSV/CSA.

Key Responsibilities

• Provide QA oversight for computerized systems validation (CSV) and remediation initiatives
• Interpret and apply FDA GxP, 21 CFR Part 11, and CSA guidance to validation processes
• Conduct periodic reviews of validated systems to ensure compliance with regulatory requirements

Required Qualifications

• Bachelor's degree (Master's preferred) in a scientific, technical, or related discipline
• 5+ years of experience in QA oversight within computerized systems validation (CSV)
• Hands-on experience conducting periodic reviews of validated systems
• Strong working knowledge of FDA Computer Software Assurance (CSA) principles
• In-depth knowledge of FDA GxP requirements and software validation guidelines