QC Microbiologist

Deeside, Flintshire

The QC Microbiologist is responsible for the performance of laboratory operations, to include raw material, utility, in-process and product testing by microbiological methods and environmental monitoring analysis.

Reporting to the Senior QC Microbiologist.

Key Responsibilities

  • Performance and reporting of microbiology testing on all raw materials, intermediates and finished products following customer, company and regulatory/industry requirements
    • Bioburden
    • Endotoxin
    • TOC, pH, conductivity
  • Performance of routine tasks and other none routine activities required in support of quality control laboratory functions.
  • Ensure all testing performed is reported within the most efficient timeframe.
  • Laboratory maintenance- housekeeping, self-inspections and stock control – support the re-order systems and communication with key suppliers.
  • Support the environmental monitoring and product testing requirements for bulk product manufacturing, including collection and processing of environmental monitoring samples and data analysis
  • Data trending and performance of quality investigations
  • Documentation of laboratory results in accordance with cGMP and company procedures.
  • Ensure training status compliant with matrix requirements and to assist in training of laboratory and production staff.
  • Maintain and improve knowledge of microbiological techniques
  • Contribute to team building, training and problem-solving initiatives internally and cross site.
  • Liaise with functional groups both within and outside QC as appropriate to ensure projects and plans are progressed
  • Preparation and execution of laboratory protocols and reports, as assigned.
  • Qualification of media, microbial techniques and relevant equipment.
  • Ensure that all laboratory activities are in compliance with all Health & Safety Guidelines, with particular reference to COSHH and Biological Safety Regulations and Health & Safety at Work Act 1974.

Skills & Qualifications:

  • HND or equivalent qualification in a relevant biological / microbiological subject area.
  • At least 2 years’ experience in a microbiology testing laboratory and experience of working in a regulated environment, pharmaceutical or medical laboratory in a related role to cGMP or within alternative quality system (UKAS/ISO 9001) such as Contract testing laboratory.
  • Essential technical knowledge in microbiology and microbiological techniques
  • Good understanding and application of cGMP and regulatory requirements including USP, PhEur, Orange guide and Current ICH guidelines applicable to the role.
  • Excellent communication / interpersonal and organisational skills, demonstrating attention to detail.
  • Be able to work in a team and individually.
  • Proficient in the use of computers and using Microsoft Office package.

Apply Now.