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Job Requirements of Quality Assurance Associate II/Third Party Management Specialist:
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Employment Type:
Contractor
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Location:
Framingham, MA (Onsite)
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Quality Assurance Associate II/Third Party Management Specialist
Careers Integrated Resources Inc
Framingham, MA (Onsite)
Contractor
Title: Third Party Management Specialist/ Quality Assurance Associate II
Location: Framingham, MA
Duration: 8 Months+ Possible Extension
Notes:
Location: Framingham, MA
Duration: 8 Months+ Possible Extension
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
- Must have Bachelor s degree + 6 years of applicable experience
- Manager is open to all levels of experience
- Previous experience with Veeva, quality agreements, supplier compliance, supplier change notifications preferred
- 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.
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