QA Technical Officer (Microbiology) - Cumbernauld, UK

Division: Bisol/Nagor

Location: Cumbernauld

Job Title: QA Technical Officer (Microbiology)

Department: Quality

Purpose of Job (Summary)

• Ensure that:
  • All environmental control systems are appropriate and effective in controlling the risk of microbial contamination of products.
  • Sterilization processes are appropriately validated and re-validated.
  • Sterilized product meets all required sterilization and microbiological specifications.
• Manage and maintain all relevant quality actions and documentation.
• Release sterilized products based on review of relevant processes and documentation and ensure all products released meet the required microbial and sterilization specifications.

Key Responsibilities

• Design, implement and maintain systems and documentation to control environmental and product contamination levels.
• Monitor environment and product contamination levels and take appropriate action to minimise product contamination.
• Maintain validated sterilisation processes in accordance with current regulatory requirements.
• Ensure sterilization and microbiological release systems are effective and maintained.
• Ensure products meet all required specifications regarding sterilization and release.
• Support the in-house Dry Heat sterilisation process.
• To have the authority to halt product release due to unacceptable risk of contamination levels or sterility risks to the product.
• Assess microbiological risks.

Qualifications / Experience

• BSc in Microbiology or a related life sciences discipline.
• Experience working within a regulated industry e.g. ISO, GLP, GMP preferred.
• Experience within quality control and/or quality assurance preferred.
• Good communication and organizational skills.
• Ability to problem solve and work independently with limited supervision.
• Good computer and IT skills including; Word, Excel, PowerPoint and databases.