Senior QC Microbiology Specialist
Contract Details
- Duration: 11 months
- Location: Carlow
Role Overview
- Provide technical support to the QC Microbiology Laboratory and site operations
- Support continued manufacture and supply of quality pharmaceutical products
- Contribute to site priorities:
- Compliance
- Supply
- Strategy
- Profit Plan
- Operate at a senior laboratory level with extended responsibilities
- Demonstrate leadership, initiative, and strong decision-making capability
- Collaborate effectively with internal and external stakeholders
- Drive innovation and technical excellence
Key Responsibilities
- Develop and execute microbiology test methods and validation studies
- Troubleshoot validation studies and routine microbiology testing issues
- Execute method and equipment validation activities
- Author and manage:
- Documentation
- Reports
- Change controls
- Procedures
- Test methods
- Deviations
- Authorise microbiological results to support batch release
- Provide microbiological support for site investigations
- Develop and deliver training modules
- Perform bench experiments as required
- Maintain and update LIMS systems
- Assess compendial and quality manual updates relevant to microbiology
- Support environmental monitoring programme:
- Trend analysis
- Corrective and preventative actions
- Support laboratory stock management and financial control
- Drive continuous improvement initiatives (e.g., lean lab, method optimisation)
- Ensure compliance with regulatory and compendial requirements
- Maintain high safety standards
- Perform additional duties as required
Experience, Knowledge & Skills
- Strong planning and organisational skills
- Excellent written and verbal communication skills
- Strong interpersonal and collaboration skills
- Ability to work within a high-performance team
- Ability to work to deadlines and under pressure
- Strong IT and software proficiency
- Commercial awareness with integrity and professionalism
- High level of initiative, motivation, and drive
- Presentation skills
- Problem-solving and decision-making capability
Qualifications & Education
- Bachelor's degree or higher (ideally in Microbiology or related discipline)
- Minimum 5 years' experience in pharmaceutical microbiology or similar regulated environment
- Strong experience in:
- Bioburden testing
- Endotoxin testing
- Sterility testing
- Method development and validation
- Demonstrated experience in change management and continuous improvement
