Job Title: Specialist 4 - Quality - Research and DevelopmentLocation(s):West Chester, PAJob Summary:This position reports into Process and Data Management (PDM) within IM Quality Systems. The Specialist is responsible for supporting clinical R&D and/or device business process owners in the end-to-end process for procedural document development and compliance training development and deployment in the Quality Management System (QMS) framework.
Key Responsibilities: - Define and manage project plans, tasks, schedules, scope, timelines, and deliverables.
- Perform project management across the life cycle from procedural document development and approval (in EDMS) to training identification, target audience identification, training material development, and training deployment (in LMS).
- Perform quality check of procedural documentation and provide feedback to business partners for consideration.
- Ongoing communication with business owners on project progress and resolution of issues.
- Work with peers in PDM to ensure compliant training and procedural documents are installed for dedicated processes.
Required Qualifications: - College Degree Required, minimum of 5 years' experience in a medium to large organization.
- Strong ability to problem solve and think critically.
- Ability to work collaboratively with a large group of internal and external colleagues and partners.
- Ability to multi-task and manage a large volume of projects.
- Strong attention to detail and highly organized, works independently.
- Strong written and verbal communications.
- Proficient in MS Office products (Outlook, Word, Excel, PowerPoint).
- Experience working with automated systems, especially Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS).
