Quality Assurance Specialist II, Supplier Quality

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, supplier performance monitoring, and leading corrective actions based on supplier audits.

• 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 and Purchasing/Procurement
• 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 updates as needed
• Monitor SCAR/Corrective Action Program
• Maintain SCAR Log and initiate supplier corrective action activities resulting from non-conforming material reports and/or supplier audits
• Follow up on action items to ensure completion

• 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.

• 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, is required.
• 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.

This will be an on-site position.

RoslinCT is proud to be an equal-opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.