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Job Requirements of Quality Assurance Associate III:
-
Employment Type:
Contractor
-
Location:
Framingham, MA (Onsite)
Do you meet the requirements for this job?
Quality Assurance Associate III
Careers Integrated Resources Inc
Framingham, MA (Onsite)
Contractor
Job Title: Quality Assurance Associate III
Location: Framingham, MA 01701
Duration: 5 months+ (Possible Extension)
Pay Range: $60 - $64/hr. on W2
Responsibilities:
Remarks:
Must have:
Nice to have:
#sczr2
Location: Framingham, MA 01701
Duration: 5 months+ (Possible Extension)
Pay Range: $60 - $64/hr. on W2
Responsibilities:
- The Third Party Management Specialist will oversee Third Party Quality operations for the MA Bio Campus, 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 Quality Third Party and requires the ability to gown and enter manufacturing
Remarks:
- 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.
Must have:
- Must have bachelor’s degree + 6 years of applicable experience
- Manager is open to all levels of experience Experience communicating with 3rd parties, understanding of 3rd party relations with impact QMS, quality agreements. Vendor pass, quality agreements, supplier change notification
Nice to have:
- Previous experience with Veeva, quality agreements, supplier compliance, supplier change notifications preferred, SAP.
#sczr2
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