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Assoc III, Quality

3 months ago

Deerfield, United States Baxter Full time

Position Summary

:

Responsible for providing Quality support and oversight for global hold activity, providing advice and direction to manufacturing plant QMR’s, Segment QMR’s, product quality leaders and local and regional hold coordinators. This role will be the global SME for the Vantive organization and will act as system owner for the Hold System. This role will be responsible for managing multiple projects independently. Demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership. A functional understanding of FDA requirements, ISO standards and the general Vantive QMS is required.

Job Responsibilities:

Leads ongoing, daily departmental operations with the global hold community including the weekly Hold Governance process which includes regional hold contacts to ensure continuous progress is made on hold closure. Develops and manages training material related to the hold management process. These courses are used globally by all users. Assists with development and management of global hold metrics which are reported in Executive Management review. Serves as Subject Matter Expert on the Hold process and is responsible for providing data for regulatory audits associated with the Hold process. Provides direct support to global Distribution and Manufacturing locations as needed Serves as the primary leason between the Global hold community and the IT technical support staff. Manage activities of self and others in achieving defined quality goals in an efficient, accurate and timely manner Be directly involved in and where appropriate lead multiple process/product improvement projects. Lead site compliance and audit ready status efforts and assist other areas within the facility in understanding FDA, ISO and Baxter quality requirements. Must be a recognized by all levels of the facility as an expert in their area and be able to demonstrate leadership ability Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP) Other duties, tasks, or projects as assigned. Support in SQLM & back up QMS

Knowledge, Skill and Abilities

Excellent interpersonal/communication/presentation/negotiation skills Effective at influencing others to meet or exceed operations or quality key performance indicators (KPIs) Able to manage multiple projects and/or responsibilities simultaneously Working knowledge of FDA Regulations and Application of Good Manufacturing Practices Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings. Must have basic English written and oral communication skills adequate to communicate with other team members. Bilingual communications is preferred since this role will interact with global operations. Must be proficient with Microsoft Office and other data collection/analysis programs (e.g. Minitab)

Required Education and Experience

Bachelor's degree desired or equivalent experience required.