As a key member of the Quality Assurance Team, the Document Control and Training Specialist will be responsible for maintenance and sustainment of the eTwist Electronic Document Management System (EDMS) and Learning Management System (LMS) used within Twist. The position requires daily management of documentation from processing draft to published to assignment of training. Oversight of the process and its adherence. Training new user on how to use the systems. High attention to detail and hands on experience using electronic document control and training processes in an ISO or GxP setting is required.
What You’ll Be Doing
Document Control Job Duties:
- Assist with Document Control administrative tasks in the eTwist documentation management system
- Processing new and update change Requests
- Routing documents for approval
- Publishing approved documents
- Periodic review and reconciliation
- Assist with the development of new documents and revising documentation as needed
Training Job Duties:
- Upload new or updated documents into the LMS eTwist
- Assign required training to employees
- Create and manage course quizzes
- Create, edit, and update course curriculums
- Ensure the training plans aligns with eTwist Training
- Manage historical training records
- Handle eTwist Training inquiries from end users
General Job duties:
- Troubleshoot eTwist system issues
- Maintain and update QMS related documents
- Quality System Metrics monitoring and reporting
- eTwist system maintenance, as applicable
- Departmental projects
- Support other Quality Systems and projects, as applicable
What You’ll Bring to the Team
- S./B.A. Degree or equivalent experience
- Minimum 5 years of biotech experience with at least 2 years direct experience in Quality Assurance, or Compliance document management
- Learning Management System knowledge and experience required
- Electronic Document Management systems experience a plus
- Strong organizational skills and attention to detail required
- Ability to multitask in a fast-moving environment
- Experience in an ISO 13485 and/or 9001 environment is a major plus
- Experience with Atlassian Confluence is highly desirable
- Master Control experience a plus
