Cpl Life Sciences
Production Operator
Midlothian
Posted about 15 hours ago
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Job Title
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.
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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.
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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.
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Skills
GMP
GDP
Clean Room Operations
Tissue Culture
Fermentation
Stock Control
COSHH
Mathematical Calculations
SOP Adherence
Reagent Preparation
Filtration
Filling and Packing