QC Associate Microbiology Specialist
RK22609
Contract – 11 months
We are seeking a skilled Microbiology Specialist to join our team at an award-winning Pharmaceutical organization based in Carlow. This is an excellent opportunity for individuals looking to work with a leading multinational company that excels in their field.
This role involves more senior responsibilities within the Microbiology Laboratory, including (but not limited to) documentation development, report writing, execution of method and equipment validation, drug product result authorization, providing microbiological support for site, and performance of bench experiments as required.
Key Responsibilities:
* Development and execution of Microbiology test methods and project validations.
* Troubleshooting issues arising during the execution of validation studies and routine tests.
* Development of training modules.
* Microbiology support to site investigations.
* Driving continuous improvement initiatives, including lean lab initiatives and method optimization/redevelopment.
* Authoring and managing change controls, procedures, test methods, and deviations.
* Result authorization for microbiological samples to support batch release.
* LIMS system updates.
* Assessing compendial and quality manual updates pertaining to the Microbiology Lab and environmental control.
* Supporting lab stock management and financial control as required.
* Supporting the environmental control program through trend analysis and implementation of appropriate corrective and preventative measures.
* Understanding and applying regulatory/compliance and compendial requirements to the role while remaining current on upcoming regulatory and compliance changes.
* Interpreting customer needs, assessing requirements, and identifying solutions to non-standard requests.
* Making decisions within guidelines and policies that impact microbiology projects.
* Ensuring the highest safety standards.
* May be required to perform other duties as assigned.
Requirements:
* Bachelor's Degree or higher preferred; ideally in Microbiology or a closely related discipline.
* 5 years' experience in the Microbiology Pharmaceutical industry or a similar operating environment.
* Demonstrated change management skills (CEM) with continuous improvement.
* Strong knowledge in execution, validation, and development of microbiology-related test methods (e.g., Bioburden, Endotoxin, and Sterility testing).
Please contact Rachel Kent at Life Science Recruitment for further information regarding this posting.