QA Specialist, Supplier Quality

RoslinCT US; Hopkinton (MA); On-site; USD 95,000 - 135,000; Full time

Job summary

RoslinCT in Hopkinton, MA is seeking a Quality Assurance Specialist – Supplier Quality to join a world-leading cell and gene therapy CDMO. You will oversee supplier documentation, change management, audits, and corrective actions in compliance with FDA regulations.

The role requires a BS in science/engineering/biochemistry and 3+ years in a regulated biopharma environment, with strong communication and organizational skills and the ability to collaborate across Supply Chain, Purchasing, and

Qualifications

• Bachelor's degree in science, engineering, biochemistry, or related discipline.
• 3+ years of directly relevant experience in a regulated biopharma or similar environment.
• Experience in supplier quality, supplier assessments/audits, supplier evaluation programs, and supplier change controls.
• Knowledge of US and EU cGMP regulations and guidance, GMP and GLP.
• Experience participating in or leading internal or supplier audits.
• Strong written and verbal communication and collaboration skills.

Responsibilities

• Onboard new suppliers to support new client programs.
• Maintain supplier qualification documentation, questionnaires and quality agreements.
• Support scheduling of audits and maintain the vendor audit schedule.
• Assist supplier audits and review supplier response documentation.
• Collaborate with Supply Chain, Purchasing/Procurement, and Manufacturing.
• Manage the Supplier Change Notification Program and review changes with cross-functional teams.
• Monitor the SCAR program and drive corrective actions from deviations or supplier audits.

Skills

Strong communication skills

Organizational skills

Problem-solving

Time management

Education

BS in science, engineering, biochemistry, or related discipline

Tools

Microsoft Office Suite

Job description

WHO WE ARE

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

THE ROSLINCT WAY

Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients.

ACCELERATING YOUR FUTURE

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:

• 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 elevate 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.

OUR COMMITMENT

All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.

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.