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The Fountain Group

Quality & Material Management Specialist

The Fountain Group, Framingham, Massachusetts, us, 01704

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Currently I have an opening for a

Quality & Material Management Specialist

located in

Framingham, MA.

Details for the position are as follows:

Job Description

The Third Party & Material Management Specialist will oversee Third Party Quality operations for the MA BioCampus, ensuring excellence in quality standards and regulatory compliance across external partnerships.

This role requires leading Supplier Change Notification (SCN) processes, managing third party quality event investigations, supporting quality agreement programs including periodic reviews and documentation, and collaborating cross-functionally with QC, Facilities, and Manufacturing departments to resolve compliance issues.

This is not a post market compliance role, this is on material compliance role – single use system, defects of materials, reach out to supplier to conduct investigations; If suppliers change something, will send out notifications.

This position reports to the Head of Supplier Governance and requires the ability to gown and enter manufacturing/warehouse areas.

Qualifications

The ideal candidate will have a Bachelor's degree or equivalent experience in Supplier Quality, minimum 6 years of Quality/Operations experience in a biotech/pharmaceutical cGMP manufacturing environment within an FDA-regulated industry.

Proficiency in Veeva quality management systems, and strong knowledge of global pharmaceutical regulations (US, EU, Canada, Japan, Australia).

Must have experience with material and vendor management.

Technical Information

8-month contract, potential for extension/conversion

Onsite, M-F, 8am-5pm

Pay: $45-51 hourly (W2), depending on experience level

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