Senior Analyst, Quality Assurance

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

This is a key quality assurance role reporting to the Quality Assurance Manager. This position performs as a Senior Analyst in Quality Assurance oversight of operations, production, process and equipment systems and computer validation at the Bioscience Laboratories Irvine (BLI).

This position is responsible for one or more of the following duties or activities:

• Provide QA oversight of operational activities, production, validations, and Technical Services projects. Ensure that QA systems and manufacturing/engineering systems undergo an independent assessment to eliminate any potential conflict of interest between ownership and administration.
• Review and approve Quality System documents: SOPs, validation and technical protocols/reports.
• Review and approve Laboratory and Non-conformance Investigations.
• Manage the review and approval of master batch records, executed batch records, manufacturing data, release testing data, and stability data, ensuring compliance with AbbVie data integrity guidelines.
• Support change management activities associated with equipment, method and process validations.
• Perform all assigned duties according to departmental SOP’s and cGMP’s.
• Remain current on proper procedures by reviewing current, revised, and new SOP’s relating to the job and to the department.
• Participate and take quality lead on process improvement projects.
• Provide support for the inspection and release of drug substance, process aids, disinfectants, and raw materials.
• Assist AbbVie in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies.

Incumbent has full autho