QA Manufacturing Compliance Specialist (Biologics) Responsibilities: Ensure that all products leaving AbbVie Biologics Ballytivnan meet the standards required for marketed and investigational drug products.Ensure that products and aseptic process simulations manufactured at AbbVie Biologics Ballytivnan meet the requirements of the end users, regulatory authorities, and the company.Provide 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.Lead/Assist in investigations arising out of product or manufacturing processes non-compliance.Review/Audit completed Batch Records.Review Manufacturing Logs as required.Complete quality review of operations documentation (SOPs, JSTMs, Risk Assessments).Complete Line Clearance activities.Complete Incoming Raw Material checks, including product status maintenance (as required).Provide Stability Program Support, e.g., sample pulls, weekly checks, protocol generation (as required).Maintain finished product status, including labeling as required.Administer Quality Logs, e.g., QA Hold, Sample Request.Lead operations floor daily walk-around of manufacturing areas.Drive continuous improvements and simplify site processes and procedures, specifically relating to the Operations function to ensure compliance is maintained at all times.Requirements: Third level degree in a science, quality, or engineering discipline.Ideally previous experience in a quality role.A minimum of three years' experience in a quality/operations role in a highly regulated GMP environment. Experience in biologics manufacturing is highly desirable.Experience in aseptic processing gained within either a quality or operations role is highly desirable.A strong knowledge of regulatory requirements is required.
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