Senior Analytical Operations Specialist - Compliance

AbbVie; Sligo; On-site; EUR 85,000 - 120,000; Full time

Job summary

AbbVie seeks a Senior Technical Analytical Specialist for its Active Pharmaceutical Ingredients site in Sligo. You will be the primary technical authority for analytical lab operations, ensuring compliance, documentation, equipment, and systems meet standards.

Work with QA, R&D, MS&T, and Lab Management to support knowledge transfer, method validation, and continuous improvement, with audit readiness at the forefront.

Qualifications

• 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.

Responsibilities

• Provide analytical testing and technical support for routine, non-routine, and advanced applications.
• Lead compliance verification for analytical results, methods, equipment, records, and data.
• Author, update, and maintain SOPs, protocols, and technical records.
• Oversee laboratory infrastructure, including asset management and equipment qualification/maintenance.
• Perform advanced troubleshooting 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 alignment.
• Mentor analysts and project teams on compliance and lab operations.
• Support audits, inspections, CAPA, and quality system initiatives.
• Drive continuous improvement in compliance, documentation, and lab systems.
• Ensure equipment is qualified and audit-ready; maintain complete documentation.
• Conduct calculations, report findings, and escalate higher-impact issues.
• Identify and resolve safety hazards and non-compliance issues in coordination with EHS.

Skills

HPLC

GC

KF

Dissolution

MS

XRD

Method development

Transfer

Troubleshooting

Education

Bachelor's degree in a science

Job description

AbbVie seeks a Senior Technical Analytical Specialist for its Active Pharmaceutical Ingredients site in Sligo. You will be the primary technical authority for analytical lab operations, ensuring compliance, documentation, equipment, and systems meet standards.

Work with QA, R&D, MS&T, and Lab Management to support knowledge transfer, method validation, and continuous improvement, with audit readiness at the forefront.