A partner to the Pharmaceutical industry is looking for a Senior Microbiologist to join its team based on the Isle of Man. You will be responsible for QC Microbiological testing to GxP standards. You must hold a BSc in a science related subject, preferably Microbiology related and have a minimum of 3 years’ experience in microbiological analysis in controlled environments to apply for this role.
Primary Function and Purpose:
- Reporting to the QC Supervisor, the Senior Microbiologist’s primary function is to support the microbiological testing for the Isle of Man manufacturing site, aid in development of new microbiology department including methods and processes, and to support the development of the aseptic culture within the business.
- The person in question will support the training of employees around risks of contamination and the implementation of good microbiological control onsite.
- The microbiologist will provide advice to different departments on reduction of microbiological incidents, support investigations, bio-digestor activity, and will support the QC supervisor in trending and reporting microbiological data.
- Perform QC microbiological testing (bioburden and endotoxin) on products, water and environmental samples, using prescribed SOPs to GxP standards to support the production and shipping schedules. Including recording all results using standardised record sheets and maintaining stored documents conforming to GDP principles.
- To develop and report on trending of microbiological incident rates identifying areas of risk and ensuring suitable control measures are put in place.
- Provide support to other departments in development and validation programs through data collection and report writing.
- Offer support and training in microbiological procedures and techniques to other staff.
- Support day to day laboratory operations such as cleaning, instrument maintenance and calibration, document archiving purchasing consumables etc.
- Support cGMP compliance tracking out of specification results, deviations, change controls, and corrective actions.
- Maintain and expand personal skills and technical training as requested by QC Supervisor/Manager.
Qualifications: BSc in a science related subject (preferably Microbiology related).
- Minimum of 3 years’ experience in microbiological analysis in controlled environments.
- Excellent written and verbal communication skills.
- Ability to work alone or as part of a team.
- Ability to troubleshoot and to perform root cause analysis of any microbiological contamination.
- Basic experience in MS Office software package
- 5 years’ experience in microbiological analysis in a pharmaceutical or clinical setting with experience in GMP or ISO9001 environments and of pharmacopoeial standards and methods.
- Microbiology method development and validation experience.
- Good understanding of quality and what it means.
- Experience in training junior microbiologists and making none-microbiologists aware of the concepts of aseptic technique.
- Experience in environmental sampling and analysis including facilities, water, and waste streams.
- Extensive experience in MS Excel and Word.
Salary £30k - £35k + relocation assistance
Job Ref: 6603