Senior Technical Analytical Specialist
Job Summary
We are looking for a Senior Technical Analytical Specialist to join our Technical Operations Team at our Active Pharmaceutical Ingredients manufacturing site in Sligo. The successful candidate will be the the primary technical authority for analytical laboratory operations across routine and advanced testing with accountability for compliance verification laboratory infrastructure and support for the new laboratory. The role combines technical stewardship with laboratory coordination to ensure analytical activities documentation equipment and systems consistently meet or exceed regulatory quality and safety standards.
Role and Responsibilities
- 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.
Qualifications :
- 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.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more