Microbiologist

Location:
Crewe
Job Type:
Contract
Industry:
Life Sciences
Job reference:
BBBH157183_1655913835
Posted:
13 days ago


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.



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