Position: Senior Specialist QC - Quality Systems (Investigations)
Location: Ireland, Dublin (Hybrid)
Contract Duration: 12 Months
Ready to take the lead in shaping the future of QC Quality Systems? Join us as a Senior Specialist QC - Quality Systems (Investigations) and drive impactful laboratory investigations, CAPAs, and quality initiatives in a rapidly growing, cutting-edge GMP environment.
We are expanding our QC Quality Systems team and are seeking a Senior Specialist QC - Quality Systems (Investigations) to lead and support a growing portfolio of QC investigations and change control activities.
Key Responsibilities:
- Lead and manage QC investigations, including OOS results, deviations, non-conformances, and laboratory investigations
- Perform and document Root Cause Analysis (RCA) and drive problem-solving initiatives
- Own and support CAPAs, including implementation, risk-based assessments, tracking, and effectiveness reviews
- Manage QC Change Control activities for new analytical methods, instruments, and QC systems
- Participate in global investigations as required and present outcomes to senior stakeholders
- Support operational excellence initiatives and continuous improvement projects
- Contribute to innovation in QC, including adoption of digital solutions and AI
- Support audits and inspections, providing documentation and read-outs as required
Required Experience & Skills
- Minimum 3 years' experience in a GMP-regulated environment
- At least 1 year hands-on experience in QC investigations
- Minimum B.Sc. in Biochemistry or a related discipline
- Strong understanding of investigation processes, RCA methodologies, CAPAs, and GMP documentation
- Experience working with or supporting CAPAs
- Strong communication skills and confidence engaging with senior stakeholders
Desirable:
- QC Change Control experience
- Background in continuous improvement or operational excellence initiatives
- QC laboratory experience (manufacturing investigations also considered)
- Knowledge of biologics QC testing (separations, bioanalytical, microbiology, raw materials, stability testing)
Why Join Us?
- Join a growing QC Quality Systems team during a period of significant site expansion
- Exposure to new facilities, technologies, and global projects
- Opportunity to shape QC processes and quality systems
- Collaborative team environment with strong leadership support
