Temporary Document Control and Training Specialist
Summary of Responsibilities:
The summary is a brief overview of the job’s main purpose and major activities.
Manage document workflows for GxP documents in the electronic document management system. Assign related training to employees per approved learning plans. Manage learning modules within the LMS.
Essential Functions Required for Job
The essential functions should describe the key responsibilities of the position in concise, comprehensive statements and address what the employee does to achieve the position’s main purpose. Please indicate the approximate percentage of time spent on each essential function.
These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties
% of Time
Create and manage workflows in the document management system to manage the life cycle of procedural documents.
Perform QC checks of documents before activating document workflows.
Process change control forms.
Maintain documentation for procedural document training and related non-procedural training.
Assign training in the learning management system as indicated on training matrices and for new or revised procedures.
Generate learning and document metrics and compliance reports and distribute to the business units.
Provide support for business groups in the use of the document and learning management system
Provide assistance in retrieving documents in support of internal and agency audits.
Facilitate requests for new user accounts for document and learning management system.
Education level and/or relevant experience(s):
Bachelor's degree in a related field or Associate degree and/or related work experience.
Minimum of 3 years’ experience in pharmaceutical or medical device environment working with controlled documents and/or learning management.
Experienced with electronic document management and learning management systems. QUMAS DocCompliance and NetDimensions Talent Suite experience preferred.
Knowledge and skills (general and technical):
Strong interpersonal, communication and customer service skills.
Good working knowledge of Microsoft Office applications.
Ability to work independently.