Manufacturing QA Specialist

About the role

AbbVie is seeking a Manufacturing QA Specialist to join the Quality Assurance team at its Ballytivnan site. The role ensures that all biologic products and aseptic process simulations meet regulatory, company, and customer requirements while supporting continuous improvement.

Key responsibilities

• Verify that all marketed and investigational drug products leaving the site meet required standards.
• Provide quality and compliance oversight for operations, including aseptic processing and intervention observation.
• Lead or assist investigations arising from product or process non‑compliance.
• Review and audit completed batch records and manufacturing logs.
• Conduct quality reviews of SOPs, JSTMs, risk assessments, and perform line clearance activities.
• Perform incoming raw material checks and maintain product status records.
• Support the stability program with sample pulls, checks, and protocol generation.
• Administer quality logs (QA Hold, Sample Request) and lead daily walk‑arounds of manufacturing areas.
• Drive continuous improvements and simplify site processes to maintain compliance.

Required profile

• Third‑level qualification in a science, quality, or engineering discipline.
• Minimum 3 years of experience in a similar role within pharmaceutical or sterile manufacturing (biologics preferred).
• Strong knowledge of regulatory requirements.
• Excellent written and verbal communication with strong attention to detail.

Required skills

• Quality Assurance
• Regulatory compliance
• Aseptic processing