Our growing client is searching for a talented Quality Assurance Specialist to join their team. In this pivotal role you will support the Quality Disposition and Distribution of the company's clinical and commercial bulk Labeled Drug Product (LDP) and Final Drug Product (FDP) to global regions and ensures compliance to Good Manufacturing and Good Distribution Practices.

What You'll Do:

• Performs Batch Record Review and Release of LDP and FDP at the CMO.
• Provides quality documents to Regulatory Affairs and Clinical Operations to support Single-Patient-Use (SPU) distribution.
• Partners with the Qualified Person on Batch Record Review and Release of LDP and FDP.
• Support technical transfer activities and ensure compliance of labeling, packaging, and distribution operations at CMO.
• Support quality aspects related to cold chain distribution.

Requirements:

• Bachelor’s Degree in Engineering or Life Sciences
• 5 years of related Pharmaceutical or Biotech industry experience in GMP regulated Biologics or Pharmaceutical environment.
• Experience in a commercial phase pharmaceutical environment.
• Advanced knowledge of relevant regulations and regulatory guidance required to act as a resource for colleagues