The QC Microbiology Analyst is responsible for performing environmental monitoring (EM) and microbiological/analytical test methods on critical utilities, raw materials, in-process intermediates and varying stages of drug products to support manufacturing of biologics products.
- Execute microbiological and analytical methods to facilitate in-process testing and final release testing such as Endotoxin, and Sterility supporting the release of biologics product.
- Execution of method validation/suitability
- Perform environmental monitoring sampling and testing of facilities, equipment, and critical utilities supporting the manufacture of biologics product.
- Evaluate completed assay validity, calculate and summarize results, analyse data per expected or specification ranges.
- Monitoring and control of laboratory supply and critical reagent inventories.
- The Microbioloy Analyst will perform growth promotion of media and microbial identification testing.
- Provide input support to the progression of test method validation, investigations, technical studies, and method transfer protocols.
- Oversee aseptic practices (gowning, monitoring, cleaning and related training).
- Develop and maintain excellent communication and collaboration between the Microbiology laboratory and operations.
- Training of other microbiology analysts where necessary
- The Microbiology Analyst will participate in the technical transfer / validation of microbiological testing procedures
- Participate in root cause analyses (RCA) as part of investigations 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 managed as per SOP.
- Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate).
- Actively support projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas.
The next Microbiology Analyst should have a degree in Microbiology or other relevant field with at least 1 years’ experience working in Microbiology in the pharmaceutical industry. Ideally you will have a strong understanding of aseptic techniques and working in Grade A/B facilities.
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