Senior IT Quality Control Specialist

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