Job Title: QC - Microbiologist
Division / Function: QC Microbiology – Technical Operations
Location: Wrexham, UK
Pay: £14.10 p/h (+ shift allowance)
Hours: 8am – 7pm with 1 hour total in unpaid breaks - 4 days on 4 days off.
Summary / purpose of the position
To support Environmental Monitoring (EM) and microbiological testing of raw materials, in-process samples and finished product in accordance with GLP, GMP and regulatory requirements.
This role is a shift position (4 on, 4 off)
Main responsibilities / job expectations
• Perform Environmental Monitoring (EM) of clean rooms and controlled environments in accordance with current testing schedules and manufacturing activities.
• Perform microbiological testing of raw materials, in-process and final product for microbial contamination within required time frames.
• Perform identification of microbial isolates to the correct level within an efficient timeframe.
• Perform QC testing of culture media to maintain available stocks.
• Maintain laboratory stock levels to support microbiological activities.
• Maintain laboratory equipment in accordance with company policies.
• Maintain specified work areas within the laboratory in a compliant state.
• Identify and initiate out of specification and out of trend results and unplanned event investigations in accordance with current procedures.
• Provide training in basic microbiological methodologies.
• Participate in the execution of validation studies and project work.
• Record and maintain QC microbiological data in a compliant state.
• Maintain a high level of housekeeping within the laboratory.
• Identify process improvements and support new initiatives.
• Ensure all work is carried out in a safe manner.
Problem solving
• Identify, initiate and contribute to out of specification and out of trend results and unplanned events.
• Provide microbiological support to assist in providing potential solutions.
• Identify and communicate non-compliances, potential or existing problems with respect to the current
ways of working. Actively suggest solutions and support new initiatives.
Standard of work/Recording of Results
• Promote accuracy and precision in daily laboratory practices with a ‘right first time’ focus.
• Adhere to relevant SOPs and standards (safety, environmental, GLP and regulatory).
Works within GMP / EHS requirements
• Perform assigned tasks whilst, at all times, adhering to current GMP requirements (e.g. Annex 1 of EU GMP) for sterile medicinal products.
• Report any compliance concerns to your line manager or the Quality Assurance Compliance team.
• Work in a safe manner at all times and raise any Health and Safety concerns to your line manager or the EHS team.
• Ensure all training is kept up to date and documented by adhering to training plan requirements, ensuring that you do not perform any tasks you are not trained to complete.
Education / Certifications:
• Ideal: Degree in scientific discipline
• Minimum: HND or equivalent experience.
Experience:
• Ideal: Experience in a microbiology laboratory role.
• Minimum: Experience within a laboratory or cGMP production environment
Key Technical Competencies Required
- Aseptic Technique.
- Aseptic Gowning.
- Training curricula / job specific training modules will be performed as per the Site Training Procedure 060023-SOP.
- Thorough working knowledge of US/EU cGMPs as applied to Biopharmaceutical testing and their practical application.
- Experience of working in a matrix organization.