Senior QA Manufacturing Compliance Specialist

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

AbbVie Biologics Ballytivnan seeks a Senior Manufacturing Compliance Specialist to strengthen our Quality Assurance operations. In this role, you'll help ensure product excellence through quality compliance, incident resolution, and floor-level support within a collaborative manufacturing environment.

Responsibilities

• Ensure all products and process simulations meet standards for market/investigational use.
• Provide quality guidance and compliance oversight throughout manufacturing.
• Lead or support investigations related to non-compliance in product or processes.
• Mentor, train, and provide support to shift team members.
• Audit batch documentation, review logs, and process SOPs.
• Support and execute line clearance, raw material checks, and stability program activities.
• Manage and maintain finished product status, labeling, and quality logs.
• Conduct daily manufacturing area walkarounds and seek process improvements.
• Support quality aspects of MVI, AQL, and NPI process/material handovers.
• Maintain compliance with cGMP, HPRA/FDA, EHS, and AbbVie standards.

Qualifications

• Third-level degree in science, quality, or engineering.
• Minimum 3 years’ experience in a GMP quality/operations setting (biologics preferred).
• Strong experience in aseptic processing and advanced knowledge of regulatory requirements.
• Excellent written/verbal communication and interpersonal skills.
• Experience as a trainer preferred.
• Demonstrated commitment to quality, problem-solving, and continuous improvement.

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