QA Specialist

Posted 5 Days Ago
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Cork, IRL
In-Office
Mid level
Healthtech • Pharmaceutical
The Role
Performs quality assurance activities for pharmaceutical manufacturing and product release, including GMP documentation review, batch release support, investigations, CAPA follow-up, audits, change controls, complaints, PQRs, training, regulatory inspections, and new product introduction. The role also supports quality assessments of clinical and commercial products, compliance initiatives, and continuous improvement projects.
Summary Generated by Built In
Company 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, X and YouTube.

Job Description

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 will contribute 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.

Qualifications

  • 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.

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 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

Skills Required

  • Bachelor's degree in a related science-based discipline
  • 3+ years of experience in quality assurance, quality oversight, or relevant experience
  • Knowledge of GMP
  • Strong organizational and time-management skills
  • Strong oral and written communication skills
  • Strong computer skills
  • Knowledge of enterprise systems such as SolTraqs, EBR, and SAP

AbbVie Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.

  • Retirement Support Retirement programs are portrayed as a standout, with a dollar‑for‑dollar 401(k) match up to 6% and an additional annual company contribution based on age and service. Feedback suggests this materially boosts perceived total compensation for many U.S. employees.
  • Parental & Family Support Paid parental and caregiver leave are emphasized, including up to 12 weeks of fully paid parental leave for all parents and 4 weeks of paid caregiver leave in the U.S. Feedback suggests these policies are a meaningful differentiator for employees balancing family needs.
  • Leave & Time Off Breadth Time off is described as extensive, with tiered vacation that scales with tenure, 17 company holidays, and two paid volunteer days in the U.S. Feedback suggests the breadth of leave contributes notably to overall benefits satisfaction.

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The Company
HQ: North Chicago, IL
50,000 Employees
Year Founded: 2013

What We Do

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, neuroscience, eye care, aesthetics and other areas of unmet need.

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