QC Microbiology Supervisor
Location: Motherwell, Scotland
Based in North Lanarkshire, Escape Recruitment are working with a leading scientific company to recruit an experienced QC Microbiology Supervisor, with specialist experience in the field of Microbiology. Leaders within cancer immunotherapy, our client has a unique culture which enables their staff to work to the best of their ability. The basis of this role will include environmental monitoring of a sterile manufacturing facility. In addition, you should have experience in batch release testing including, Sterility testing, Endotoxin testing and Bioburden and microbial identification techniques. You will work with and support the Quality Control, Production and Quality Assurance teams to ensure operational excellence and to exercise overall responsibility for the Quality Control Microbiology department.
- Accountability for all QC Microbiology procedures within the multipurpose cleanroom facility.
- Performing cleanroom qualification/validations and reporting data to ensure the facility is fully compliant to Annex 1
- Verification and validation of microbiological methods and ensuring reports are completed to the highest standard
- Ensuring effective environmental monitoring is conducted for viable and non-viable particles and subsequent reporting of trending data to senior management.
- Investigation of microbiological excursions within the manufacturing facility and reporting of trending analyses. Advising on corrective and preventative actions to improve sterility assurance.
- Supervision and development of structures, policies, processes and procedures to ensure effective and accountable use of resources across the Quality Control Microbiology department.
- Analysis of intermediate and final products in full compliance with the controlled methods and procedures and to GMP requirements.
- To ensure work is performed in accordance with the Company’s QA and Health and Safety policies including the provision of COSHH/BIOCOSHH/Risk assessments.
- To ensure Microbiological equipment is calibrated and maintained in accordance with GMP quality systems. Ability to identify deviations and faults in instrument performance and determine an appropriate response to such events.
- Training and supervision of both experienced and inexperienced members of staff as appropriate, ensuring that technical knowledge and competence is communicated effectively. Where applicable, coach and mentor colleagues to ensure continuance of a high level of microbiological expertise.
- A good understanding of a Quality Management System, including, but not limited to, laboratory notebooks, standard operating procedures, change controls, study protocols, deviations, environmental monitoring excursion, quality investigations, Out of Specifications, TSE evaluations, COSHH/BIOCOSHH assessments and risk assessments.
- Assisting the line manager in laboratory management activities including, but not limited to, equipment planning/procurement, ordering of reagents and consumables, maintaining calibration and servicing records, ensuring equipment compliance and ensuring a clean, organised and smooth running working environment.
- Experience in microbiology techniques such as microbial identification is essential.
- Excellent understanding of EU GMP Annex 1 is essential.
- Knowledge of environmental monitoring and trending of a sterile GMP manufacturing cleanroom is essential.
- Knowledge and understanding of an aseptic manufacturing environment is essential.
- Previous supervisory experience is beneficial.
- Validation experience of Cleanrooms and Microbiological equipment is beneficial and cleaning validation experience is beneficial.
- Degree level education in a sciences discipline.
- At least 5 years’ experience in a similar role within a GMP compliant company
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