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Location
Jersey City, NJ | United States
Job description
Our Client, a growing company focused on Cell Therapy, is looking for a Quality Assurance Specialist
The QA Specialist's responsibilities will be as follows:
1. Deviations Management:
- Investigate and manage deviations from established procedures, ensuring swift resolution and meticulous documentation.
2. Internal Audits:
- Plan, conduct, and report on internal audits to guarantee adherence to regulatory requirements and uphold internal quality standards.
3. Nonconformities Addressing:
- Identify, assess, and address nonconformities, implementing corrective actions to prevent recurrence and enhance overall product quality.
4. CAPA Leadership:
- Drive the Corrective and Preventive Actions (CAPA) process, including root cause analysis, strategic corrective action planning, and effectiveness verification.
5. Critical Supplier Collaboration:
- Collaborate with cross-functional teams to manage critical suppliers, ensuring their adherence to rigorous quality standards.
6. Document Control (Veeva Vault):
- Oversee document control activities using Veeva Vault, including document revisions, approvals, and maintenance to uphold regulatory compliance.
7. Change Control Evaluation:
- Evaluate and manage change controls, ensuring seamless implementation in accordance with regulatory requirements.
8. Mock Batch Recall Reports:
- Contribute to the preparation and execution of mock batch recall reports to assess and enhance the effectiveness of our recall procedures.
Qualifications:
- Bachelor's degree in a relevant scientific field.
- Proven experience in quality assurance within the biopharmaceutical or cell therapy industry.
- In-depth knowledge of regulatory requirements and quality standards.
Job tags
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