Senior Specialist, Quality Systems

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

Job Description

About AbbVie AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

The Sr Specialist Quality Systems within the Product Quality Assurance department is responsible for providing quality assurance support for the biologics manufacturing processes at AbbVie Bioresearch Center. Specific areas of support may include, but not limited to New Product Introduction (NPI), Shop Floor Manufacturing, Document Change Control, Batch Release, and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product disposition are in compliance with Corporate and governmental regulations.

Responsibilities

· Serve as the Quality reviewer and approval for of change requests, including but not limited to site policy/procedure, standard operating procedures, test methods, and batch records.

· Complete and route change requests for quality system documentation and specifications with guidance from technical teams following approved templates and guidelines.

· Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality syste