QA Specialist II, Supplier Quality

Roslin CT US Holdings,LLC•Hopkinton, MA

4d•$65,000 - $80,000•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

Experience in cell therapy is a plus.

Responsibilities

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, and 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 by reviewing change notifications with cross-functional team and escalating customer and supplier notifications with potential impact, and supporting change controls for raw material or supplier-related updates.
Monitor Supplier Corrective Action Request (SCAR) Program by maintaining SCAR Log and initiating supplier corrective action activities resulting from deviations, non-conforming material reports, and/or supplier audits, and following up on action items to ensure completion.