Senior QC Specialist – Analytical Lab SME

AbbVie; Sligo; On-site; EUR 65,000 - 85,000; Full time

Job summary

AbbVie in Ballytivnan, Sligo, seeks a QC Senior Specialist to join the Quality Control team. You will report to the QC Lab Manager and act as the SME for the analytical lab, guiding cross-functional teams and ensuring the lab remains compliant with data integrity policies and regulatory requirements.

You will transfer and validate analytical methods, qualify new equipment, manage documentation, lead OOS investigations and CAPA, and develop training materials for QC analysts, contributing to

Qualifications

• At least 5 years of analytical experience in the pharmaceutical industry.
• A third-level qualification in a relevant science discipline.
• Experience in a GLP/GMP environment and knowledge of current cGMP and EU/FDA/ICH/HPRA guidelines.
• SME-level knowledge of HPLC, Identification, Conductivity, Protein Concentration, Osmolality and pH.

Responsibilities

• Support the transfer and validation of analytical test methods.
• Implement and qualify new laboratory equipment, and ensure existing equipment is maintained.
• Ensure laboratory documentation and computerised systems comply with data integrity policies and regulatory requirements.
• Provide technical input for the lab's analytical work during regulatory inspections, ensuring full compliance.
• Review pharmacopoeia requirements and develop in-house lab procedures to meet them.
• Generate and manage analytical technical reports and oversee CAPA actions.

Skills

Analytical experience

QC expertise

Cross-functional collaboration

Education

BSc / MSc in science

Tools

HPLC

Lab equipment

Job description

AbbVie in Ballytivnan, Sligo, seeks a QC Senior Specialist to join the Quality Control team. You will report to the QC Lab Manager and act as the SME for the analytical lab, guiding cross-functional teams and ensuring the lab remains compliant with data integrity policies and regulatory requirements.

You will transfer and validate analytical methods, qualify new equipment, manage documentation, lead OOS investigations and CAPA, and develop training materials for QC analysts, contributing to