Production Operators

Our client who delivers innovative high-quality products, focusing on the health and wellness of patients and the day-to-day productivity and satisfaction of our clinical diagnostics partners, is looking to hire Production Operators to perform procedures and duties in compliance with agreed specifications for the manufacture of high-quality diagnostic products according to GMP. Perform and progress, under the direction of the area of Team Leader, a range of skilled/complex tasks within manufacturing departments, utilising acquired knowledge, experience and/or qualifications.

Responsibilities

• Conduct all duties in compliance with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and appropriate regulatory requirements in any of the areas listed in this document.
• Undertake and participate in continuous training and assessment in accordance with personal development plan.
• Maintain accurate and legible records to ensure relevant laboratory documentation is kept in a satisfactory condition.
• Maintain equipment, in accordance with agreed procedures, ensuring equipment is operating correctly.
• Check and maintain work environments according to the requirements of GMP and relevant Health and Safety policies contributing to the maintenance of agreed standards.
• Actively participate in the review in updating of procedures, SOP’s and any other relevant documents.
• Participate in the training of less experienced staff members.
• Perform any other duties as reasonably requested from the Company from time to time.

Formulation - Specific Activities

• Ensure product is manufactured to specification to agreed schedules.
• Complete appropriate documentation and TROPOS efficiently and correctly.
• Ensure manufacturing processes adhere to TROPOS/SOP. Processes may include
  • Buffer/Reagent preparation,
  • filtration and filling of buffers/reagents to be progressed to a clean room environment,
  • adsorption of unwanted antibodies,
  • conversion of plasma donations to serum,
  • the concentration, potentiation, dilution and / or formulation of monoclonal antibodies
• Ensure awareness of COSHH/ Risk Assessments.
• Perform accurate mathematical calculations.
• Maintain accurate stock control.

Red Cell Department - Specific Activities

• Ensure product is manufactured to relevant specification and to meet agreed schedules.
• Complete appropriate documentation and TROPOS efficiently and correctly.
• Maintain excellent levels of cleanliness and housekeeping.
• Adhere to GMP guidelines, TROPOS and company standard operating procedures at all times.
• Check and maintain liquid nitrogen storage area and stocks according to SOPs.
• Perform accurate mathematical calculations.
• Ensure awareness of COSHH/ Risk Assessments.

Monoclonal Department - Specific Activities

• Progress monoclonal cell lines in accordance with appropriate SOPs for Cell Banking, Tissue Culture or Fermentation.
• Ensure cultures progress according to monoclonal production schedule and discuss alterations to schedule with Line Manager.
• Complete appropriate documentation and TROPOS efficiently and correctly.
• Maintain laboratory stock levels.
• Ensure awareness of COSHH/ Risk Assessments.

Fill, Label & Pack department - Specific Activities

• Ensure product is filled to meet relevant specifications according to schedule.
• Complete appropriate documentation and TROPOS efficiently and correctly.
• Ensure sufficient consumables are available for scheduled fills.
• Ensure labels are printed and available for scheduled fills.
• Ensure relevant material is filtered according to procedures and in time for scheduled fills.
• Label and pack product to meet relevant specifications according to schedule.
• Ensure awareness of COSHH/ Risk Assessments.

Buffer and Mosaiq Reagent Department - Specific Activities

• Ensure product is manufactured to meet specification to meet agreed schedules.
• Ensure manufacturing processes adhere to TROPOS/SOPs.
• Preparation of Buffer and Reagent products to agreed specification.
• Prepare and deliver intermediate buffer solutions for the Manufacturing departments.
• Filtration and filling of buffers within a clean room environment.
• Fill, Label and Packing of Reagent products.
• Ensure awareness of COSHH/ Risk Assessments.
• Complete appropriate documentation and TROPOS efficiently and correctly.
• Perform accurate mathematical calculations.
• Maintain accurate stock control.

Production Services Department - Specific Activities

• Maintain excellent levels of cleanliness and housekeeping in the Manufacturing environment.
• Maintain accurate stock control of Clean Store.
• Prepare and deliver equipment and raw materials to complete product manufacture according to schedule.
• Ensure adequate stock of prepared consumables required for production activities.
• Complete appropriate documentation and TROPOS efficiently and correctly.
• Ensure adequate stock of cleaning products, clean room attire and clean room environmental monitoring plates is available.
• Ensure awareness of COSHH/ Risk Assessments.