Analyst, QA

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

The QA Analyst supports the Quality Manager in the execution and oversight of the Quality System, with primary responsibility of batch record review, batch release documentation, and product shipment authorization. This includes support for policy and procedures, program management, internal and external audits, and metrics, trend analysis, and reporting.

Responsibilities

Responsible for implementing and maintaining the effectiveness of the quality system; Reviews batch release documentation and batch records to support product disposition and shipment authorization; Tracks, trends, and reports on batch record and product release activities; Release batch records in electronic systems according to global, local, customer, and regulatory requirements. Ensure all in-process and release testing is complete and all quality holds can be removed for release; Ensure batch records are retained and filed securely based on applicable document retention procedures; Owns and drives updates to AbbVie Product specification documents; Provides effective quality controls for commercial products, including solid dosage forms, select liquids, and vials, as well as third-party manufactured products; Monitors compliance with all AbbVie and Pharmacy Solutions policies and procedures, in addition to all federal, state, local governmental, and pharmacy laws and regulations; Develops QA training programs and materials and provides training to departmental personnel; Evaluates, analyzes, and trends quality indicators, data, and performance metrics, and prepares daily and monthly reports of Pharmacy Solutions quality measurements; Manages QA lists, spreadsheets, and databases as required to support the business; Participates in Quality Improvement initiatives and assures customer satisfaction; Conducts investigations and provides timely resolutions to variance, incident, and exception issues, participates in the development and implementation of permanent corrective actions; Prepares ad hoc quality and other reports as requested by management and external customers; Conducts internal audits on business functions of Pharmacy Solutions and supports external audit logistics and operations

Requirements

BS in a scientific discipline or related experience; Minimum of 2 years’ experience in a Quality related field; Strong computer skills utilizing a Microsoft environment (e.g. Word, Excel, Access, PowerPoint); Good oral, written, and presentation skills; Sound decision making and problems solving skills to assure business unit compliance; Strong analytical skills, ability to analyze data and trends and draw conclusions; Good mathematics background with an understanding of basic statistical concepts

Nice to have

Experience with batch record release and documentation