Quality Systems Senior Specialist

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The  Quality Systems Senior Specialist is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.

This role is part of the External Quality Assurance (EQA) team responsible for product quality across a portfolio of topical skincare products that include Natural Health Products, Cosmetics, Homeopathic and Over the Counter (OTC) Drugs. 

Responsibilities

•Responsible for various aspects of quality assurance and quality control related to products produced.
•Ensures that product is consistently manufactured in conformance with AbbVie Quality System requirements and all applicable regulatory requirements.
•Supplier oversight, assuring responsible Third Parties are complaint with cGMPs, regulatory and corporate compliance requirements and contractual agreements as applicable.
•Assist project teams in planning new product launches and tech transfer.
•Ensure proper integration and support of quality regulations: drug, biologics, device and/or combination products.
•Assist project teams in planning, preparation, review and approval of quality  documentation.  Responsible for developing a process to maintain citation history.  Monitor changes to legislation, regulations and statutes that may impact retention and/or require changes to the AbbVie Recor