Microbiologist

Microbiologist
Holmes Chapel
12 months
£20 per hour via umbrella

This role provides testing, reporting and investigation laboratory activities to enable compliant, on time delivery of product to market. This is a key position within a QC team ensuring that the exacting standards of GMP, Site procedures, HSE and LEAN are delivered at all times.

• Quality Microbiologist conducts testing, reporting of results and investigations within the microbiology laboratory (product testing, facilities/utilities and microbiology laboratory support areas).
• The Quality Microbiologist is charged with performing their work in a safe and effective manner in compliance with cGMP, Biosafety and Regulatory requirements.
• The function of this position is to perform Microbiological sampling and testing following approved methodology, to assure that the potency, purity, safety and stability of our products, components and facilities/utilities are in compliance with approved specifications.
• Additionally, this position evaluates Microbiological methods, reviews test results, highlights problems related to technical and equipment issues and works closely with the Senior Quality Microbiologist/Microbiology Quality Leader to aid resolution of any issues. All staff may be required to perform additional duties as agreed by the supervisor.

KEY RESULTS/ACCOUNTABILITIES

• Conducts testing of QC samples for the specific laboratory area and manage own workload
• Analyse data using standard procedures
• Contribute to quality key performance indicators and deliver, measure/trend data to team.
• Challenge and seek improvements in ways of working/processes
• Perform testing according to prioritisation and contribute to any improvements
• Provide Microbiological/lab support for Team Leader in internal, Global regulatory inspections and customer audits when required.
• May have involvement in the training of other members within the team, particularly in the case of team members who are new and inexperienced.
• Has regular involvement with investigations (i.e. Events/ILI/FSI), working within their local area to aid in problem solving, identification of root cause and meaningful CAPA.
• Recognises opportunities for change and has a proven ability to drive change in the local area.
• May be required to support in the review of analytical methods and compendia to ensure compliance for both GMP and HSE considerations

Qualifications
A science degree / HND/ NVQ 4 or equivalent with at least 1 years working experience in a GMP
environment

SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS

• Good technical knowledge and expertise of quality control principles and systems in a GMP environment.
• Computer-literate with experience in the use of Laboratory (LIMS, Data capture) systems as well as MS Word, Excel and PowerPoint
• Demonstrated ability to actively participate in projects and investigation
• Knowledge and understanding of global pharmaceutical regulations and guidelines.
• Demonstrates competence and clarity in both written and oral communication e.g. presentations at team meetings, ability to write ILIs and demonstrates understanding to execute FSIs as well as non-complex technical and investigational reports, communication at team meeting
• Good interpersonal skills with an ability to communicate procedures and concepts within the team and on occasions to the department. Ability to train instructional techniques
• Self-motivated with ability to plan and manage own workload with some supervision during the working day.
• Challenges and questions locally and across team ways of working to seek improved processes and performance
• Takes responsibility for supporting change, is prepared to take or support action, and/or escalate to ensure implementation of appropriate actions
• Ability to respond to auditor questions and describing local systems on external audit tours with positive outcomes
• The individual should have good knowledge and understanding of the principles and concepts of compliance management and GMP/GLP
• The individual should have a good understanding of analytical chemistry or microbiology, laboratory instrumentation and/or related information systems.
• The individual should have a basic understanding of the industry and be responsive to of regulatory changes, new technologies, Pharmacopoeial requirements and their impact on the function.
• An understanding of own quality assurance function, as well as a basic understanding of other functions and how they contribute to achieving the objectives of the business.
• The individual has some understanding of business functions and supports reacting to issues on how QC performance impacts functional customer service.