QC Associate Microbiology Specialist
We are currently recruiting for a highly skilled QC Associate Microbiology Specialist to join our award-winning Pharmaceutical organization in Carlow.
This is an excellent opportunity for someone looking to take on more senior responsibilities within the Microbiology Laboratory, including documentation development, report writing, method and equipment validation, drug product result authorization, and providing microbiological support for site.
Duties:
* 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.
* Aesssing 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.
Experience and Education:
* 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).