As a key member of the Quality Assurance Team, the Document Control and Training Specialistwill 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
The base cash compensation for this California-based role is below. In addition to base salary, this role is eligible for bonus, equity, and a generous benefits package. Final compensation amounts are determined by multiple factors, including candidate skill, experience, expertise, and location and may vary from the amount listed above. Compensation may be different in other locations.