Role Title:
QC Microbiology Specialist
Location:
Carlow- Ireland (Onsite)
Role Overview:
A key opportunity has arisen for a
QC Microbiology Specialist
to provide technical support to the QC Microbiology laboratory and operations. The role ensures the continued manufacture and supply of high-quality pharmaceutical products while meeting compliance, supply, and strategic priorities. This position includes senior responsibilities such as documentation development, report writing, method and equipment validation, sample result authorization, and providing microbiological support across the site.
The ideal candidate will demonstrate strong self-management, decision-making, leadership, and collaboration skills, helping the team achieve high performance. Strong engagement with internal stakeholders (e.g., QC Analytical, Technical Operations, QA) and external partners is central to success. Innovation, drive, and technical excellence are essential.
Key Responsibilities:
* Develop, validate, and execute microbiological test methods and project validations.
* Troubleshoot issues during routine tests and validation studies.
* Create and deliver training modules for microbiology procedures.
* Provide microbiology support for site investigations.
* Drive continuous improvement initiatives, including lean lab practices and method optimization.
* Author and manage change controls, procedures, test methods, and deviations.
* Review and authorize microbiology sample results to support batch release.
* Maintain and update LIMS records.
* Support environmental control programs through trend analysis and corrective actions.
* Maintain lab stock, financial oversight, and resource management.
* Apply regulatory, compliance, and compendial requirements to laboratory operations.
* Interpret customer or operational needs and provide solutions to non-standard requests.
* Ensure compliance with safety standards and operational protocols.
* Perform other duties as required.
Experience, Knowledge & Skills:
* Strong planning, organizing, and project management skills.
* Ability to work effectively in a high-performance, cross-functional team.
* Excellent verbal and written communication skills.
* Ability to work under pressure and meet deadlines.
* Strong interpersonal skills for interacting with a wide range of stakeholders.
* Self-starter with focus, drive, and initiative.
* Commercial awareness with integrity and professionalism.
* Proficient in relevant IT and laboratory software.
* Passion for continuous improvement and problem-solving.
Qualifications & Education:
* Bachelor's degree or higher in Microbiology, Life Sciences, or a closely related discipline.
* Minimum 5 years of experience in a pharmaceutical microbiology laboratory or similar regulated environment.
* Demonstrated expertise in developing, validating, and executing microbiology test methods (e.g., Bioburden, Endotoxin, Sterility testing).
* Proven experience in continuous improvement and change management initiatives.