Microbiology Analyst

Job description

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. 


 Job Responsibilities;

  • 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.

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.