Quality Coordinator (3468)

Summary Labeling Change Control Coordinator Department:
(optional) Function:
(optional) Med Products Quality Systems Labeling Design and Development Summary (optional) Demonstrate facilitation of large scale labeling change projects, and successful management of multiple change projects within TrackWise change management system. Coach internal business partners in the preparation of product labeling change control projects.
Essential Duties and Responsibilities.
This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned. o Responsible for managing multiple labeling change control projects encompassing a varying degree of scope and complexity. o Responsible to perform accurate product data entries in a change control management system. o Organize and facilitate label change control project updates and approval meetings, as appropriate. o Ensure all document and system elements are identified, accurate and assembled for review and approval. o Ensure change control project deliverables are closely monitored to successfully meet project milestones. o Responsible to understand and comply with change control and labeling design and development procedures. The incumbent will perform other duties as assigned.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. 0 N/A:
Intern or Co-op o Excellent Project Management skills (ability to work under strict deadlines and changing priorities.) o Ability to manage multiple labeling change projects by managing long-term deadlines and anticipating project steps to ensure projects are consistently completed on time. o Ability to proficiently use Microsoft Office Suite, including MS Project o Good conceptual and analytical skills. o Demonstrates excellent interpersonal/communication/influencing/negotiating skills, with the ability to speak effectively before groups. o Demonstrates dependability, initiative, flexibility, and adaptability. o Ability to make quick, sound, decisions with limited data. o Ability to solicit feedback and information from others in an open environment. o Ability to build relationships across functional boundaries at multiple levels internally and externally.
Education and/or Experience.
Include the education and/or experience that is necessary to perform the job satisfactorily. 0 N/A:
Intern or Co-op Bachelor's Degree preferred or 4 years or more years of experience with data management, change control systems or document configuration management. 1-2 years of change control experience. 1-2 years of project management experience 1-2 years of experience leading teams

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