David Smith

Equipment setup and operatation in a biologics processing environment for plasma derived pharmaceuticals. Strict adherence to procedures and practices according to FDA regulations. Aherence to departmental, corporate and safety polocies. Responsible for performing daily tasks: Cleaning / Sanitizing aseptic and non-aseptic components. Utilizing touch screen operator interface terminals (OIT).

Approved incoming plasma shipment documentation and raw materials by confirming specifications, rejects, returns and unacceptable materials as directed by QA Supervisor. Generate and document non-conformance of plasma units rejected from plasma shipments, in process batches or final plasma Lots. Approved in-process plasma batches (PUs) and final plasma lot shipments by confirming customer and regulatory specifications and communicating required adjustments to the QA Supervisor. Responsible for inspecting final outgoing plasma lot shipments to ensure all pallets are properly packaged and loaded for sales and distribution. Investigation and report in-process/final product and processes that do not meet quality specifications and document in a deviation report. Participated in the writing or revision of policies and standard operating procedures related to Source Plasma and quality systems. Documents approval activities in the organizations (Plasma Management System) to maintain accurate records.

Receive, segregate, and identify plasma cases upon arrival of plasma trucks. Identify and store plasma pallets in warehouse freezers. Maintain FIFO. - Maintain proper inventory levels in designated warehouse areas such as the Chemical Dispensary Area in accordance with actual and projected usage.