The Quality Assurance Specialist - 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. - 3+ 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. Final compensation will be based on a variety of factors, including education, experience, technical expertise, specialized skill sets, market demand, internal equity, and business needs. At RoslinCT, we offer more than just competitive pay. Our comprehensive Total Rewards package is designed to support your health, financial well-being, and professional development throughout your career. Benefits include medical, dental, and vision insurance, educational assistance, a 401(k) program, and a variety of additional resources to help you thrive both personally and professionally. Department Quality Assurance Locations Hopkinton Yearly salary $70,000 - $100,000 Employment type Full-time