Sage Therapeutics

Quality Management System Consultant

US-MA-Cambridge
3 weeks ago(11/27/2017 10:26 AM)
ID
2017-1938
# of Openings
1
Category
Quality/Regulatory

Overview

 

Responsibilities:
This position will be responsible for managing various activities in support of the Quality Management System, including but not limited to:

  • Issuing numbers for document change requests, controlled documents, change controls, deviations and CAPA’s. 
  • Manage and track the status of controlled documents, change controls, CAPA’s and Deviations.
  • Manage Sage document Training Notifications and Effective Notice Notifications.
  • Manage and maintain document and record filing.


Additionally, this role will support other activities in support of the electronic document management system (eDMS) and the electronic learning management system. (eLMS)

 

Qualifications:

  • Preferred Bachelor’s degree in science with 3+ years’ experience in a GMP regulated environment
  • Thorough understanding of quality document control process and requirements.
  • Understanding of the Quality Management System and the integral role of procedural documents.
  • Experience working with both manual and electronic document and training management processes.
  • Understanding of global regulatory requirements around document and training quality systems.
  • Experience with ensuring compliance of documentation in a regulated environment.
  • Experience with good documentation practices
  • Must have advanced experience with Microsoft Word and the ability to utilize formatting, editing, styles, etc.
  • Excellent organization skills
  • Detail oriented.
  • Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun
  • Excitement about the vision and mission of Sage

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