The Quality Assurance Specialist II - Supplier Quality supports quality activities related to Supplier Quality Management in compliance with FDA regulations and internal SOP's. Responsibilities include supplier documentation management, change management, performance monitoring, leading supplier-related corrective actions and investigations, and audit support. How You Will Make an Impact: Provide support the supplier qualification program by: • Onboarding new suppliers in support of new client programs • Maintenance of supplier qualification documentation including questionnaires and quality agreements • Support scheduling of audits and maintenance of the vendor audit schedule • Support supplier audits and review of supplier response documentation • Collaborate internally with key stakeholders in Supply Chain, Purchasing/Procurement, and Manufacturing • Manage the Supplier Change Notification Program • Review change notifications with cross-functional team and escalate customer and supplier notifications with potential impact • Support change controls for raw material or supplier-related updates • Monitor Supplier Corrective Action Request (SCAR) Program • Maintain SCAR Log and initiate supplier corrective action activities resulting from deviations, non-conforming material reports, and/or supplier audits • Follow up on action items to ensure completion What You Will Bring: • A highly organized work style that ensures timely execution of tasks. • A mindset that ensures accurate results. • Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint). • Effective problem-solving capabilities. • Strong oral and written communication skills. Qualifications: • B.S., in science, engineering, biochemistry, or related discipline, or combination of education, experience and training. Experience in cell therapy is a plus. • 2-5 years with directly relevant experience in a regulated environment, biopharmaceutical environment or similar. • Working knowledge of supplier quality, including supplier assessments/audits, maintaining supplier evaluation program, supplier corrective actions, and supplier process changes. • Practical knowledge of US and EU cGMP regulations and guidance, GMP and GLP regulations. • Past experience of participation in or leading internal or supplier audits • Strong communication skills (written and verbal), influencing, negotiating and collaboration skills. • Demonstrate strong organizational skills including ability to prioritize tasks and adhere to agreed timelines. • Ability to manage and deliver multiple tasks with limited supervision. • Travel may be required up to 10% of the time.