The QA Senior Specialist is responsible for providing quality assurance support for the pharmaceutical plant. 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. Develop plans, coordinates and drives for execution Quality projects across multiple site QA areas. Coordinate with site QA planners to achieve project deliverables. Coordinate with centralized function the deployment of global Pharma 3 initiatives. Analyze, manage and maintain data for cycle times, touch times, and tasks/process lists to optimize QA processes performance. Drive for development, improvement and maintenance of site QA planning and scheduling activities. Assure QA areas under scope of the project implement and maintain visual management tools to monitor key QA processes. Analyze and report metrics for planned and unplanned activities for key QA processes. Anticipates and identifies areas of risk and mitigates risks through early risk assessments and implementation of fallback / mitigation strategies. Lead development of the Project Charter and documents the requirements that satisfy the stakeholders’ needs and expectations. Establish project objectives and criteria for evaluating project results and activities of the project team. Support Regulatory inspections for new market introduction. Lead and or coordinate Compliance and Performance improvement projects. Provide status to site management of the assigned projects. - Maintains an effective liaison and cooperative relationship with Quality areas from Third Party Contractors (TPC) *This position will be based in Grand Rapids at a third-party manufacturing facility*
Bachelor’s Degree in Business Administration, Sciences or Engineering. Six (6) years of experience in Quality area position, with hands on experience in the following areas: Project Management, Scheduling and Inventory Control. The incumbent must have hands-on experience in Excel, Word, Power Point, etc. Knowledge of statistics is desirable. Must be familiar with the Good Manufacturing Practices and Good Laboratory Practices
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html