Quality Assurance Specialist, Supplier Quality
RoslinCT
Summary
The Quality Assurance Specialist II – Supplier Quality supports quality activities related to Supplier Quality Management in compliance with FDA regulations and internal SOPs. Responsibilities include supplier documentation management, supplier performance monitoring, and leading corrective actions based on supplier audits.
Job description
How You Will Make an Impact
- Onboard new suppliers in support of new client programs
- Maintain 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
- 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
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
Requirements
- B.S. in science, engineering, biochemistry, or related discipline, or combination of education, experience and training
- 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
- Experience in cell therapy is a plus
Benefits
- Flexible Work Environment
- Attractive Benefits Package
- Work-Life Balance
Company overview
RoslinCT is a leading global contract development and manufacturing organization (CDMO) specializing in advanced cell and gene therapies. Founded in 2005 as a spin-out from the renowned Roslin Institute, the company builds upon the groundbreaking scientific legacy that produced Dolly the Sheep, the world's first cloned mammal. With dual headquarters in Edinburgh, Scotland and Hopkinton, Massachusetts, RoslinCT operates 22 purpose-built cGMP cell therapy processing suites across both locations. The company provides comprehensive CDMO services including process and analytical development, cGMP clinical and commercial manufacturing for both autologous and allogeneic cell therapies, iPSC cell line development, gene editing, and differentiation. RoslinCT has achieved significant industry milestones, including being among the first to produce clinical-grade human pluripotent stem cells and advancing the first CRISPR-edited stem cell-based therapy to marketing authorization. The company partners with biotechnology and pharmaceutical companies worldwide to accelerate the development and commercialization of life-saving cell and gene therapies, with a strong focus on quality, innovation, and patient impact.