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Duke University Job Description: |
Job Title: DOCUMENT CONTROL SPECIALIST |
Job Code: 1759 |
FLSA: E |
Job Level: 12 |
Revised Date: 11/21/2016 |
Job Family: JF 28 |
This position is responsible for maintaining documents while ensuring their accuracy, quality, and integrity; assisting the Administrative Manager with the day to day operations in typing documentation, formatting, numbering, organizing, and publishing documents using appropriate applications in the electronic document management system.
Assist in the coordination of controlled document preparation for all Programs.
Assist with the production of standard operating procedures, summary reports, and technical documents according to specific format standards and guidelines to ensure compliant documents in the document management system
Proofread/spell check documents for accuracy, consistency of formatting, and use of terminology to endorse quality.
Actively support the creation and maintenance of document templates.
Work closely with document authors about preparation of documents, and inform authors of any problems with templates or source documents.
Assist in providing a basic level of technical support to the user community.
Support user requests appropriately.
Liaise with contact at EMMES to supply updated, effective documents.
Assist the System Administrator with any requirements as needed.
Troubleshoot basic technical issues with the document management system and/or our IT support and resolve expeditiously.
Liaise with staff to review priorities and ensure deadlines are met.
Ensure that external and internal regulations and policies governing document management and document control are met.
Maintain an awareness of evolving industry standards for document generation and electronic document management.
Provide support for audits (internal/external).
Actively participate in change control committee meetings.
Assist in the preparation of regulatory submissions with requested document control needs; i.e., printing procedures, creating reports, table of contents, and assembly of binders.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
| Education/Training: | Work requires an Bachelor's degree in a related field |
| Experience: | Three to five years related experience in document processing/document management in a biotech, pharmaceutical, or contract research organization. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE |
| Skills: | Use of a document management system, such as Master Control, preferred. Possess strong technical skills with proficiency in using various computer programs/applications, including Microsoft Word, Excel, PowerPoint, Visio, and Outlook. Knowledge of FDA regulations and industry standard guidelines for electronic records; i.e., 21 CFR Part 11. Team player with sense of urgency to carry out tasks in a timely and accurate manner. Possess an acute attention to detail and be exceedingly good at multitasking. Ability to interact well with employees at all levels. Strong organizational skills. Excellent verbal, written, and interpersonal skills. Possess good problem solving skills. Adapt to changing priorities effectively. Ability to work independently on assignments. Dependable and trustworthy with a work ethic that exudes pride in your work. |
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.