Quality Assurance Specialist
2 weeks ago
Job Title: Quality Assurance Associate II
Location: Framingham, MA
Duration: 06 months with possible extension
Job description:
Internal Title: Third Party Management Specialist
Some slight flex on schedule start/ stop time
Fully onsite position/ Free parking onsite
*Local candidates only
• 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:
• Must have Bachelor's degree + 6 years of applicable experience
• Manager is open to all levels of experience
Nice to have:
• 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.
EEO:
"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."
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