QC Microbiology Specialist

Orion Group Sciences are currently recruiting a QC Microbiology Specialist on behalf of our Multinational Pharmaceutical client based in Carlow on an initial 11-month contract (with potential to extend).

Responsibilities:

• Development and execution of Microbiology test methods, Method Validation and Method Qualification, mainly bioburden, endotoxin, and Sterility test methods.
• Troubleshooting of issues which arise 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, 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 & environmental control.
• Supporting lab stock management and financial control as required.
• Supporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures.
• Understands and applies regulatory / compliance and compendial requirements to their role together with remaining current on upcoming regulatory and compliance changes.
• Interprets customer needs, assesses requirements, and identifies solutions to non-standard requests.
• Makes decisions within guidelines and policies which impact microbiology projects.
• Ensure highest safety standards.
• May be required to perform other duties as assigned.

Knowledge, Skills, Experience, Qualifications:

• Bachelor's Degree or higher preferred; ideally in Microbiology or a closely related discipline.
• Demonstrated change management skills (CEM) with continuous improvement.
• Strong knowledge in execution, validation, and development of microbiology related test methods i.e., Bioburden, Endotoxin and Sterility testing.
• At least 5 years' experience in the Microbiology Pharmaceutical industry or a similar operating environment.
• Knowledge and experience in interpreting current applicable regulatory requirements and providing independent support to the site.
• Strong knowledge in the area of method development including experiment design to ensure robust validation data.
• Demonstrated ability to work independently and fully realize improvement initiatives with minimal guidance.
• Demonstrated ability to drive the completion of tasks.
• Demonstrated delivery of SME knowledge above site.
• Demonstrated successes in a team environment, such as project teams, Six Sigma team etc.
• Advanced PC skills such as Excel, Word, PowerPoint.
• Demonstrated ability to clarify, communicate and solve complex problems.
• Highly motivated and interested in bringing current microbiology research and technology platforms toward a biopharmaceutical operations application.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.