QA Specialist – Supplier Quality (Biopharma)

RoslinCT; Hopkinton (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

RoslinCT in Hopkinton, MA, is seeking a Quality Assurance Specialist – Supplier Quality to strengthen our supplier ecosystem in a fast-moving cell and gene therapy environment.

You will manage supplier qualification, audits, change controls, and the SCAR program, collaborating with Supply Chain, Purchasing, and Manufacturing to ensure cGMP compliance.

The ideal candidate has a biology/engineering background, 3+ years in regulated biopharma, and strong communication and organizational skills.

Qualifications

• B.S. in science, engineering, biochemistry, or related field.
• 3+ years in a regulated biopharma or similar environment.
• Knowledge of supplier quality, audits, and supplier evaluation programs.
• Working knowledge of US/EU cGMP, GMP and GLP regulations.
• Experience in internal or supplier audits.
• Strong communication, influencing, negotiating and collaboration skills.
• Strong organizational skills and ability to prioritize tasks.
• Travel up to 10% of the time.

Responsibilities

• Onboard new suppliers and maintain qualification documentation.
• Support scheduling of audits and vendor audit schedule maintenance.
• Review supplier change notifications and support change controls.
• Monitor the Supplier Corrective Action Request (SCAR) program and follow up on actions.
• Collaborate with Supply Chain, Purchasing/Procurement, and Manufacturing.

Skills

Organizational skills

Communication skills

Problem-solving

Multitasking

Education

B.S. in science/engineering/biochemistry

Tools

Microsoft Office Suite

Job description

RoslinCT in Hopkinton, MA, is seeking a Quality Assurance Specialist – Supplier Quality to strengthen our supplier ecosystem in a fast-moving cell and gene therapy environment.

You will manage supplier qualification, audits, change controls, and the SCAR program, collaborating with Supply Chain, Purchasing, and Manufacturing to ensure cGMP compliance.

The ideal candidate has a biology/engineering background, 3+ years in regulated biopharma, and strong communication and organizational skills.