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Microbiology Analyst

Job description

Job Responsibilities;

  • Responsible for supporting the manufacture of a biologic’s product.
  • Perform aseptic practices.
  • The Microbiology Analyst will perform microbiological testing as well as environmental monitoring as required to support operations.
  • Ensure that the Microbiology laboratory is set up and operates in compliance with cGMP/ GMP at all times.
  • Implement and maintain standards of GLP and analytical practice consistent with current regulatory expectations and Global standards.
  • Receive training from the Senior Microbiology Analsyt.
  • Following schedules and directions from the Senior Microbiology Analyst.
  • Ensure that testing schedules are achieved to provide a comprehensive analytical service for testing of all samples.
  • Help the Senior Microbiology Analyst to oversee the P3 environmental monitoring programme for the facility.
  • Participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing.
  • Investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence. Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are followed as per SOP.
  • Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate, customer).
  • Maintain standards of safety to ensure a safe working laboratory. Ensure that the laboratory is kept clean, tidy and safe at all times.
  • Participate as required in global project teams relating to Microbiology and wider quality activities.

 Requirements;

  • The Microbiology Analyst will have a degree in Microbiology or another relevant field.
  • 2 years’ experience working in Microbiology in the pharmaceutical industry preferably in a Biologics company
  • Experience of microbiology testing including Sterility, endotoxin, mycoplasma and Environmental Management
  • Knowledge and experience of Lean Laboratories is preferable
  • Previous experience in setting up a new Microbiology laboratory is desirable

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