Senior Technical Analytical Specialist
AbbVie View all jobs
- Sligo
- Permanent
- Full-time
- Provide analytical testing and technical support for routine, non-routine, and advanced applications, ensuring testing meets product, safety, and quality requirements.
- Lead compliance verification for analytical results, methods, equipment, records, and data to ensure alignment with internal standards and external requirements, including cGMP, GLP, ICH, FDA/HPRA, and EHS.
- Author, update, and maintain SOPs, protocols, and technical records to support audit readiness and regulatory compliance.
- Oversee laboratory infrastructure, including asset management, equipment purchasing, qualification, maintenance, and workflow optimization, particularly for new laboratory spaces.
- Perform advanced troubleshooting, technical investigations, and support method validation, transfer, and integration activities.
- Collaborate with R&D, MS&T, Quality, Process, EHS, and Lab Management to support knowledge transfer and operational alignment.
- Mentor and coach analysts and project teams on compliance, verification, laboratory operations, equipment use, and best practices, without formal people management responsibilities.
- Support internal and external audits, regulatory inspections, CAPA development, and quality system initiatives.
- Drive continuous improvement in compliance, documentation, workflow efficiency, process modernization, and laboratory systems.
- Ensure equipment is qualified, maintained, and used in line with compliance and safety standards, with complete audit-ready documentation.
- Conduct calculations, report findings, and escalate analytical or verification issues supporting high-impact investigations and improvement projects.
- Identify and help resolve safety hazards and non-compliance issues in coordination with EHS and Lab Management.
- Maintain accurate, complete, and current records for all laboratory activities.
- Complete handover of validated analytical methods to QC, ensuring smooth transfer of knowledge, protocols, and compliance requirements.
- Degree or diploma in a science discipline.
- 5 – 7 years experience in a similar role.
- Extensive hands-on experience with analytical techniques such as HPLC, GC, KF, dissolution, MS, XRD, and others.
- Strong expertise in method development, transfer, validation, and troubleshooting.
- Thorough knowledge of cGMP, GLP, ICH/CDER, FDA/HPRA, and EHS requirements, with experience in compliance verification.