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Senior QA Manufacturing Compliance Specialist

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Sligo, Sligo
Posted 8 hours ago
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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.
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