Fractionation Technician
Clayton, North Carolina
• Responsible for performing duties to manufacture products derived from human blood plasma, which require comprehension in the following areas: Science (biology or chemistry), Engineering, Mechanical aptitude, Computers, Various process equipment (Centrifuge, Automatic bottle opener, CIP skids) that interface with process controls automation.• Complete record keeping in accordance with current Good Manufacturing Practices (cGMP).• Follow Standard Operating Procedures (SOP's) and complete Batch Production Records (BPR's).• Work in an ethical and compliant manner to manufacture a drug product that is safe for human use.• Follow company safety guidelines and programs.• Demonstrate care of facility, equipment, systems, and product.• Demonstrate appropriate personal hygiene and proper gowning.• Operate manufacturing process control system and equipment.• Assist in the harvest of intermediate products, sampling operations, and the preparation, set up and transfer of Buffer and Process solutions.• Operate Clean – In – Place (CIP) equipment• Perform in process analytical analysis• Monitor status of manufacturing processes• Transfer intermediate product, raw materials, and waste• Stage plasma, intermediate paste and raw materials• Clean and/or Sanitize designated manufacturing areas• Utilize SAP and / or ACSIS transactions• Support the supply chain requirements for production• Assist team members, including supervision, to perform additional tasks• Executes commissioning and validation activities associated with a new building.