Job Title: Quality Control Specialist
Work Type: Contract
Location: Carlow
Role Overview:
An exciting opportunity has arisen for a talented QC Associate Microbiology Specialist to join a leading pharmaceutical team in Carlow. The role is perfect for an experienced professional looking to make a significant impact in a fast-paced, cutting-edge environment. This position offers the chance to provide technical support to the Quality Control (QC) Microbiology Laboratory while contributing to the manufacture and supply of high-quality pharmaceutical products.
Key Responsibilities:
The QC Associate Microbiology Specialist will be a key player in the operations of the Microbiology Lab and will take on a range of senior responsibilities, including:
* Method Development & Validation: Developing and executing microbiology test methods, project validations, and troubleshooting any issues that arise during validation studies.
* Microbiology Support: Providing microbiological expertise for site investigations and ensuring compliance with regulatory standards.
* Continuous Improvement: Driving continuous improvement initiatives, including lean lab practices, method optimization, and development.
* Documentation & Reporting: Authoring and managing change controls, procedures, test methods, deviations, and ensuring accurate and timely documentation.
* Result Authorization: Authorising microbiological sample results to support batch release.
* Training & Development: Developing training modules and supporting team development through collaboration and coaching.
* Environmental Control: Supporting the environmental control program through trend analysis and corrective/preventative actions.
* Regulatory Compliance: Staying up to date with the latest regulatory requirements and ensuring these are applied to all aspects of microbiology testing and procedures.
* LIMS System Updates: Managing LIMS system updates and ensuring proper handling of microbiological data.
Experience, Knowledge & Skills:
* Proven experience in microbiology testing, method validation, and laboratory operations.
* Strong planning and organisational skills, with the ability to work effectively under pressure.
* In-depth knowledge of microbiological testing methods such as Bioburden, Endotoxin, and Sterility testing.
* Demonstrated experience in change management and continuous improvement processes.
* Strong interpersonal skills and the ability to communicate clearly, both verbally and in writing.
* Self-starter with a passion for delivering high-quality results and strong commercial acumen.
* Ability to work effectively in a high-performance team environment.
Qualifications & Education:
* A Bachelor’s Degree or higher in Microbiology or a closely related field.
* At least 5 years of experience in the Microbiology Pharmaceutical industry or a similar operating environment.
* Strong knowledge in the execution, validation, and development of microbiology test methods.
* Demonstrated ability to manage change and lead improvement initiatives.
Take the Next Step:
If you're a driven and innovative QC Associate Microbiology Specialist looking for a rewarding role with an established organisation, this is your chance to make a meaningful contribution to the future of the pharmaceutical industry.
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