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Lonza
,
Livingston, West Lothian
Micro Analyst QC (Microbiologist)
Overview
Job Description
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. This role reports to the Quality Control Manager and will primarily be responsible for the management of a team of analysts conducting analytical activities, QC (Quality control) testing and release of materials, packaging components and finished products. The role will be responsible for providing technical expertise at both a theoretical and practical level. The ideal candidate will therefore have a pharmaceutical analysis background and have gained experience within a cGMP, FDA and MHRA regulated environment. Key responsibilities: * Work as part of a team alongside Production and Development * Actively involved in planning and supervising the execution and reporting of routine microbiology testing to determine fitness for purpose of starting materials, intermediate and finished products. * Technically competent in microbiology activities. * Key aspects of this role will include performing a set of basic Microbiological tests such as Micro limit testing of Non-Sterile Products of raw materials, and finished products, Environmental Monitoring, Growth promotion testing of incoming media, Gram staining, Water TVC testing. * All activities to be performed under current cGMP (Goods Manufacturing Practice), Lonza SOP's and/or pharmacopoeia. * Conduct calibrations in accordance with SOP (Standard Operation Procedure). Conduct the purchasing of consumables and maintain stock levels as required for the operation of the microbiology laboratory. * Ensure Out of Specification results are reported at the time of discovery and communicated to relevant internal and external personnel. * Ensure laboratory work sheets and notebooks are completed appropriately to record experimentation. Complete Environmental monitoring reports as per frequency defined in SOP. Key requirements: * Relevant qualification, HNC/HND/Science Degree or Equivalent experience * An understanding of drug development and manufacturing processes * Experience with pharmaceutical or biotechnology industry * Demonstrated technical competence of the technical and practical skills involved in analytical activities to prescribed quality standards * Proven ability to work to key regulatory and compliance requirements * Skilled in Microbiology techniques including Microlimit testing, Environmental monitoring, TVC testing * Able to communicate well with others, both laboratory and non-laboratory based * Able to work with minimal supervision. * Good understanding of quality control, SOP and GMP adherence People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.