QC Analyst

The individual in this position should have a strong working knowledge of the cGMP QC laboratory environment and laboratory equipment associated with biopharmaceutical analysis. The position requires the ability to understand and follow written SOPs, to accurately and legibly record work in real time, and pay close attention to detail. The individual must be able to perform routine tasks with a minimum of supervision.

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• Perform all lab functions in compliance with cGMP.
  
• Follow written procedures for the following tests, as trained and qualified:
  
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  • Electrophoresis (iCE)
    
  • HPLC methods including but not limited to; Size Exclusion, Reverse Phase, Peptide, Mapping, Anion Exchange, Titre.
    
  • Protein Concentration
    
  • Compendial Methods such as pH, Osmolality, and Appearance.
    
  • Stability scheduling and testing.
    
  
  
• Recognize and report aberrant test results and sample conditions.
  
• Ensure training is current for all job functions performed.
  
• Provide QC SME and day to day technical guidance to QC analyst personnel.
  
• Data review (including peer and logbook review) and authorization as required.
  
• Support the QC management team as required.
  
• Lead and complete execution of investigations/CAPAs in a timely manner.
  
• Training lead in specific assays overseeing the execution of all training activities for all new personnel.
  
• Drive continuous improvement initiatives within the QC department.
  
• Support the laboratory housekeeping and 5S to ensure audit readiness.
  

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• In depth knowledge of current regulatory requirements for Chemistry methods in support of cGMP operations supporting clinical and commercial manufacturing.
  
• Good technical knowledge in the area of Chemistry.
  
• Good experience in investigation methodology and method troubleshooting.
  
• Ability to follow written procedures with close attention to detail.
  
• Good report writing and technical writing skills.
  
• Ability to function with minimal supervision for routine job duties. xcfaprz
  

BSc in Chemistry or a biological science, 1-4 years’ experience, or equivalent combination of education and experience.