Quality Assurance Associate II | Third Party Management Specialist

Job Description

Job DescriptionJob Title: Quality Assurance Associate II | Third Party Management Specialist
Job Location: Framingham, MA 01701
Job Duration: 8+ Months (Possibilities of Extension)

Shift: Work shift: STD
Pay Rate: $48.00 - $51.00/Hour. on W2

Job Description:

• The Third Party 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.
• 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).
• This position reports to the Head of Supplier Governance and requires the ability to gown and enter manufacturing/warehouse areas.

Must have:

• Must have Bachelor’s degree + 6 years of applicable experience
• Manager is open to all levels of experience

Notes:

• Fully onsite position/ Free parking onsite
• Role will work with some of the smaller vendors, will reach out to and worker
• This is not a post market compliance role, this is on material compliance role – single use system, defects of materials, they’ll reach out to supplier to conduct investigations; If suppliers change something, will send out notifications

Nice to have:

• Previous experience with Veeva, quality agreements, supplier compliance, supplier change notifications preferred.

#sczr2