Quality Assurance Analyst

Job Summary

Quality Assurance Analyst is a full-time remote position responsible for providing technical and administrative support for software development activities, ensuring compliance with federal standards and quality expectations throughout the system development life cycle.

Key Responsibilities

• Provide oversight of software development activities to ensure compliance with federal and user standards
• Review software deliverables and documentation for accuracy and adherence to quality standards
• Support the development and quality control of Computer Systems Validation (CSV) plans and conduct risk assessments

Required Qualifications

• 2-5+ years of experience in clinical software quality assurance or validation within regulated industries
• Demonstrated experience applying GxP principles across the full system life cycle
• Hands-on experience with Computer Systems Validation (CSV) activities
• Strong working knowledge of GAMP 5 guidance and risk-based validation approaches
• Proficiency in reviewing technical documentation related to software development