We are looking for a QC Microbiologist to join our client’s biopharmaceutical site in Waterford. The function of this position is to provide microbiological support and knowledge to the micro team and to other departments. This position also includes performing microbiological testing as required by following approved methodology to assure that the safety, quality, purity and stability of the products, components and in-process stages are in compliance with approved specifications.
Key responsibilities:
• Provide microbiological support to the Quality Assurance, Qualified Persons, Validation and Manufacturing departments as well as other areas on site.
• Documentation review and batch release review.
• Provide technical guidance and expertise to QC Microbiology Team and external departments. In particular, close contact maintained with the Microbiology, Validation, Manufacturing, Planning and Quality Assurance.
• Execution of QC-Micro testing (water sampling, water testing, growth promotion, identifications, Sterility testing, Environmental monitoring and plate reading) as required.
• Compliance with cGMP and Standard Operating Procedures at all times.
• Actively contribute to continuous improvement initiatives in the lab.
• QC Micro representation at cross functional meetings.
• Providing audit support for tours and presentations as required.
• Supporting projects as required.
• Conduct duties in a safe manner and report all safety issues or concerns.
Requirements and qualifications:
• Degree in Science or related area (Microbiology, Biotechnology, Pharmacy, Chemistry or Biochemistry preferred).
• 2-3 years working within Microbiology in a Pharmaceutical/GMP facility, ideally part of which would be in microbiology or a lab environment.
• Excellent communication skills, natural influencer, and ability to work effectively in cross -functional teams as well as working solo.
• Understands Key Performance Indicators.
• Knowledge of quality management systems (e.g. Veeva/Qualipso).
• Knowledge of lab management systems (e.g. LUNA).
• Be a motivated, ambitious and goal oriented individual.
It would be advantageous to have (not essential)
• Experience in performing plate reading, water testing, endotoxin testing, sterility testing, requalification’s, or knowledge of use and maintenance of microbiological equipment.
