QC Microbiology Analyst
What will this job involve?
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 under minimal supervision and within cGMP guidelines, to support manufacturing of biologics products.
- Execute microbiological and analytical methods to facilitate in-process testing and final release testing such as Endotoxin, Mycoplasma, and Sterility supporting the release of biologics product.
- Execution of method validation/suitability
- The microbiology analyst will 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.
- Perform growth promotion of media and microbial identification testing.
- Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures; perform initiation of investigation records within required timeframes.
- Provide input support to the progression of test method validation, investigations, technical studies, and method transfer protocols.
- Training of other microbiology analysts where necessary
- Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples.
- The analyst will participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing
- 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.
- Implement and maintain standards of safety to ensure a safe working laboratory. Ensure that the laboratory is kept clean, tidy and safe at all times.
What do you need?
- Degree in Microbiology or other relevant field with at least 1 - 2 years’ experience working in Microbiology in the pharmaceutical industry, preferably in a Biologics company Strong knowledge and practical experience in aseptic techniques and working in Grade A/B facility.
- Experience of microbiology testing including Sterility, endotoxin, mycoplasma and Environmental Monitoring
- Knowledge of GMP and current FDA & EMEA regulations
- Excellent organizational, communication, interpersonal and report writing skills
- Good Microbiology knowledge
- Ability to work independently and meeting established timelines.
- Demonstrated adaptability and flexibility to support a growing organisation.
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