Job Description

Immediate need for a talented Quality Assurance Associate III. This is a 06+months contract opportunity with long-term potential and is located is located in Framingham, MA(Onsite). Please review the job description below and contact me ASAP if you are interested.

Job Diva ID: 26-09060

Pay Range: $50 - $57/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities: -

• 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 Quality Third Party and requires the ability to gown and enter manufacturing

Key Requirements and Technology Experience:

• Key skills: 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
• Previous experience with Veeva, quality agreements, supplier compliance, supplier change notifications preferred, SAP
• 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 Quality Third Party and requires the ability to gown and enter manufacturing

Our client is a leading Healthcare Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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