- 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.
- 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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