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.
#J-18808-Ljbffr