Job Descriptions

A snapshot of your key responsibilities as a QA Manufacturing Compliance Specialist would be:

• Ensure that products and aseptic process simulations manufactured at AbbVie Biologics Ballytivnan meet the requirements of the end users, regulatory authorities and of the company.
• Providing quality and compliance oversight and assistance to the Operations function of the company to manufacture products in compliance with all site policies and procedures.
• Provide quality oversight during the aseptic processing of products, including aseptic intervention observation.
• Leading and assisting in investigations arising out of product or manufacturing processes non-compliance.
• Review of completed Batch Records.
• Drive continuous improvements and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times.
• Completion of Line Clearance, incoming material and product quality checks as required.

Education and Experience

• Bachelor’s Degree, preferably in Science or Microbiology, or equivalent related work experience is required.
• 3+ years of Biopharmaceutical experience in a sterile aseptic environment.
• Knowledge of regulations and standards for pharmaceuticals (e.g. CFR, EU GMP).
• Ability to evaluate quality, production and support areas for compliance to GMPs. SOPs, etc.
• Ability to identify and investigate problems and help to resolve them.

Skills

Experience

• 3+ years