Amanda Blount

Experience

1. Sr Qa Supervisor, Batch Release

   ProKidney Corp.

   Feb 2023 — Present

   Manages the disposition of clinical drug products and GMP materials within a cGMP manufacturing environment. Responsibilities include overseeing batch record review and approval, coordinating QA shipment activities for clinical trial materials, and ensuring adherence to FDA, EU, and ICH regulatory requirements.Leads batch and material release processes, issues Certificates of Analysis and Certificates of Conformance, and provides oversight for Deviations and Change Controls. Additionally, plays a key role in training QA team members in batch review and release activities. With a strong emphasis on compliance, efficiency, and continuous improvement, the Senior Supervisor has enhanced batch release operations, streamlined QA shipment workflows, and fostered cross-functional collaboration to strengthen quality oversight. Areas of expertise include batch record review, material disposition, deviation management, regulatory compliance, and team training, ensuring operational excellence in a high-demand environment.

Education

• Elizabeth City State University

  Bachelor of Science (BS), Biology/Biological Sciences, General

  2005 — 2009