Specialist 4 - Quality - Research and Development

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.

Job Title: Specialist 4 - Quality - Research and Development

Location(s): West Chester, PA

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.

• 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.

• 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).
  
  

Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.