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