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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.
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.
Qualifications:
- 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.