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QA Specialist - Supplier Quality

Full Time

Philadelphia, Pennsylvania, United States (This job can be hybrid)

Job description

Scismic is supporting the growth of a Contract Development and Manufacturing Organization (CDMO) specializing in the innovative and rapidly evolving field of cell and gene therapy.

Position Overview

The company is seeking a highly motivated and detail-oriented Quality Assurance Specialist to join their dynamic team. The successful candidate will play a crucial role in ensuring the highest standards of quality and compliance are maintained throughout the cell and gene therapy manufacturing process. The QA Specialist will collaborate with cross-functional teams to implement and maintain robust quality systems, ultimately ensuring the delivery of safe and effective therapies to patients.

Key Responsibilities:

  • Conduct supplier audits and assessments to evaluate and qualify new and existing suppliers.
  • Collaborate with cross-functional teams to establish criteria for supplier selection and approval.
  • Develop and maintain quality agreements with critical suppliers, outlining expectations and quality standards.
  • Ensure adherence to quality agreements by conducting regular reviews and updates as needed.
  • Foster strong relationships with suppliers through effective communication and collaboration.
  • Act as a liaison between internal teams and suppliers to resolve quality issues and drive improvements.


  • BS life sciences.
  • 5-10 years of experience in QA within biologics, with a focus on maintaining supplier quality program.
  • Experience establishing quality agreements, performing supplier audits, and managing supplier change notifications.
  • Experience communicating directly with the FDA, clients, and other external bodies during regulatory inspections and client audits.
  • Experience conducting internal audits to assess compliance with quality systems and identify areas for improvement.
  • Support external audits by regulatory authorities and clients, ensuring a high level of readiness and responsiveness.

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