QC Microbiology Analyst – Pharmaceuticals – Dublin – Contract.
The QC Microbiology Analyst will be responsible for qualifying the Microbiology Quality Control lab and the transfer of Microbiological analytical methods including but not limited to cutting edge Rapid Microbiological Methods.
Overview of Main Responsibilities (full job description available on request):
- Perform supporting activities for general lab readiness, laboratory equipment qualification, and method transfers.
- Perform and carry out a variety of routine microbiological analytical techniques including but not limited to environmental monitoring, WFI testing, growth promotion testing, In-process product testing, Final product testing such as bioburden, and both Kinetic turbidimetric and MCS rapid endotoxin testing in compliance with GMP requirements.
- To integrate and complete all documentation on time and be familiar with LIMS.
- To train and be trained in the use of Rapid microbiology techniques including but not limited to endotoxin testing, water bioburden testing, E.M testing, absence of bioburden testing, and identification testing.
- Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations, and industry standards.
- To update SOP’s and write protocols as required.
- Support the laboratory testing schedule to achieve an efficient QC system.
- Receive and manage samples that come into the lab for stability, in-process and release testing.
- Reagent preparation, cleaning, and routine equipment maintenance.
- Maintain good housekeeping and GLP within the laboratory.
- Calibrate and maintain all designated laboratory instruments.
- Assist in training new QC Analysts on routine procedures and practices.
- This position will be on days initially but shift work will be required.
What the ideal candidate looks like:
- Degree qualification (Science/Quality/Technical).
- Preference Lean Six Sigma
- 2 + years of industry experience with significant knowledge and experience in working in a microbiology lab unit and working with contract labs.
- Experience in compendial testing for water and environmental monitoring in cleanroom environments.
- Working knowledge of QC Systems (Empower, LIMS, Trending systems.)
For a confidential discussion and more information on the role, please contact Aisling Lane.