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.
- 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
That job description is matching your professional expectations? Send us your CV!
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.