Specialist, Global Quality Assurance

The Global QA Specialist will support the implementation and maintenance of the quality management system (QMS), manage internal and external audits, and ensure training compliance. Key responsibilities include preparing and reviewing internal documents and reports, documenting and tracking quality events, providing QA support for client audits, conducting internal and vendor audits, and supporting external audits and inspections. They will also assist in developing and maintaining policies and procedures, tracking training compliance, reviewing training records, supporting computer system validation documentation reviews, and interpreting regulatory requirements. Additionally, the specialist will coordinate vendor qualification and due diligence activities, support internal audit programs, ensure quality oversight and ongoing compliance, contribute to quality metrics tracking and trend analysis, and participate in process improvement initiatives.