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Quality Control Microbiology

Job description

As a QC Microbiology Analyst you will be in charge 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. Your tasks will be :

  • Execute microbiological and/or analytical methods to facilitate in-process testing and final release testing such as Endotoxin, Mycoplasma, and Sterility
  • Execution of method validation/suitability
  • Perform environmental monitoring sampling and testing of facilities, equipment, and critical utilities
  • Evaluate completed assay validity, calculate and summarize results, analyse data per expected or specification ranges.
  • Compilation and verification of trend analysis reports.
  • Monitoring and control of laboratory supply and critical reagent inventories.
  • 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.
  • Perform other responsibilities as deemed necessary
  • Oversee aseptic practices (gowning, monitoring, cleaning and related training).
  • Develop and maintain excellent communication and collaboration between the Microbiology laboratory and operations.
  • Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples.
  • 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.

The next QC Microbiology Analyst must have a degree in microbiology or other relevant background, 1 year ‘experience working in the microbiology area in a pharmaceutical/biology company is required. As well as experience of microbiology testing including Sterility, endotoxin, mycoplasma and Environmental Monitoring. Knowledge and experience of Lean Laboratories is preferable.

Interpersonal skills:

  • Excellent organizational, communication, interpersonal and report writing skills
  • Ability to work independently and meeting established timelines.
  • Knowledge of cGMPs, Good Microbiology knowledge
  • Successful track record in achieving goals as part of a team within a growing, dynamic environment
  • Self-motivated and ability to work under pressure, Ability to adapt to changing priorities

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