QA Specialist

AbbVie; Cork; On-site; EUR 55,000 - 75,000; Full time

Job summary

AbbVie Cork site is seeking a QA Specialist on a fixed-term contract to support GMP‑compliant QA activities related to manufacturing and product release.

The role emphasizes reviewing data, investigations, CAPA, documentation, audits, and QA training, with collaboration across BeX and regulatory requirements to ensure quality and compliance.

Qualifications

• Bachelor’s Degree in a related science discipline.
• 3+ years’ experience in quality assurance or quality oversight.
• Knowledge of GMP, good organisation skills and time management.
• Strong oral and written communication skills.

Responsibilities

• Review batch manufacturing data to confirm GMP compliance.
• Verify bulk product labelling and contribute to QA of finished products.
• Lead or support investigations into discrepancies, failures, quality events, and CAPA follow-up.
• Review, write, and approve GMP documentation (SOPs, reports, specifications, validation protocols, quality contracts).
• Support internal and supplier audits, conduct monthly GMP compliance walkdowns, and track actions to closure.
• Manage change controls, complaints, and Product Quality Reviews (PQRs).
• Prepare QA metrics and communicate key issues to QA Operations leadership.
• Participate in regulatory and client audits and site inspections.
• Assist with GMP training programs and presentations.

Skills

GMP knowledge

Quality assurance

Documentation skills

Communication skills

Computer skills

Education

Bachelor's degree in a science related discipline

Tools

SolTraqs

EBR

SAP

Job description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn,Facebook,Instagram,XandYouTube.

We are looking for a QA Specialist to join our Quality Assurance team in Cork on a Fixed Term Contract until September 2027.

As a QA Specialist you willcontribute to the implementation and maintenance of Quality Assurance actions in compliance with the current GMP regulations, with primary responsibility for the quality assurance operations activities in the Cork Site in relation to manufacturing and release of product.

Responsibilities:

• Review batch manufacturing data, systems, and documentation to confirm GMP compliance and support timely batch release.
• Verify bulk product labelling and contribute to the quality assessment of commercial finished products.
• Lead or support investigations into discrepancies, failures, quality events, and external complaints, ensuring effective CAPA follow-up.
• Review, write, and approve GMP documentation, including SOPs, reports, specifications, validation protocols, quality contracts, and exceptional documents.
• Support internal and supplier audits, conduct monthly GMP compliance walkdowns, and track actions through to closure.
• Manage change controls, complaints, and Product Quality Reviews (PQRs), while preparing QA metrics and communicating key issues to QA Operations leadership.
• Participate in compliance initiatives and support the preparation, execution, and follow-up of regulatory and client audits, as well as site inspections.
• Assist with the preparation and delivery of GMP training programs and presentations in line with internal procedures and applicable cGMP requirements.
• Represent QA on Business Excellence (BeX) projects, supporting GMP improvement, digital transformation.
• Ensure QA activities meet applicable health, safety, and regulatory requirements; support New Product Introduction (NPI) activities and contribute to the quality assessment of clinical, pre-commercial, and investigational medicinal products.

• Bachelor’s Degree in a related science based discipline.
• 3+ years’ experience in quality assurance, quality oversight or relevant experience.
• Knowledge of GMP, good organisation skills and time management.
• Strong oral and written communication skills needed.
• Strong computer skills and knowledge of enterprise systems such as SolTraqs, EBR & SAP.

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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html