
Quality Control Microbiologist
- Dublin
- Permanent
- Full-time
- Responsible for API and Water testing with expertise in at least the following methods of analysis: Total Viable Count, Endotoxin Testing using Gel Clot and either Kinetic Chromogenic or Kinetic Turbidimetric methods, Coliform Testing
- Coordinate and perform environmental monitoring of packaging areas
- Investigate QC and API Manufacturing microbiology issues with support of QC Lead and Group Microbiologist
- Conduct analytical validation of microbiological methods
- Introduction of new techniques to the lab, including method transfers, validation protocols
- Train QC Chemists in appropriate microbiology test methods and procedures
- Other project work as determined by Quality Control Lead
- Support other QC tasks as required
- Strict adherence to Aseptic techniques including sampling
- Strict adherence to GMP, including SOPs and Standard Works and where relevant, use of Pharmacopeial standards
- Key role in microbiology related risk assessments
- Adhere to the site safety program
- Continuously improving the efficiency and performance of the QC Microbiology laboratory through:
- Implementation of modifications, improvements and work simplifications as appropriate
- Ensuring that investigations and root cause analysis are completed to drive improvements and determine root causes where required.
- Bachelors Degree in Microbiology.
- Minimum 3 years relevant microbiology testing laboratory experience in a GMP/pharmaceutical setting, using hands-on analytical techniques
- Analytical Validation
- Experience with Contamination Control Strategy for API manufacturing plant with low bioburden / endotoxin limit
- Cleanroom design and operation
- Aptitude for computer operations essential
- LIMS experience advantageous
- Demonstrated lean capability advantageous
- Change control