Incoming QA Specialist

About the role

AbbVie is seeking an Incoming QA Compliance Specialist to join its Biologics site in Ballytivnan, Sligo. Reporting to the IQA Supervisor, you will ensure that all raw materials, single‑use assemblies and bulk drug substances meet the required quality standards before release for manufacturing.

Key responsibilities

• Perform incoming quality assurance (IQA) release of raw materials, single‑use assemblies and bulk drug substance.
• Ensure timely release of materials in compliance with site policies, procedures and timelines.
• Provide quality oversight of sampling requirements for excipients, including aseptic sampling.
• Lead or assist investigations arising from specification results for IQA materials.
• Coordinate with approved contract laboratories for quotations, processing and release of samples.
• Review and audit completed release records; author specifications and standard operating procedures.
• Act as subject‑matter expert during regulatory and internal inspections.
• Complete quality reviews of operational documentation (SOPs, JSTMs, risk assessments).
• Support stability programs, including sample pulls, weekly checks and protocol generation.
• Maintain finished product status, labeling, and administer quality logs (QA Hold, Sample Request).
• Drive continuous improvement and simplify site processes related to operations compliance.

Required profile

• Level 8 (3rd level) qualification in Science, Quality or Engineering.
• Minimum 2 years experience in a quality role for incoming materials.
• At least 3 years experience in a regulated GMP environment.
• Strong knowledge of regulatory requirements.

Required skills

• Good Manufacturing Practice (GMP) knowledge.
• Regulatory compliance expertise.
• Quality assurance processes.
• Specification authoring and SOP development.
• Investigation and root‑cause analysis.

What we offer

• Opportunity to work in a global, research‑based biopharmaceutical company.
• Collaborative environment focused on scientific innovation and patient impact.