- Reviews and analyzes proposed changes to controlled documentation
- Ensures documentation meets all division, corporate, and department requirements
- Performs training in change control procedures and other department functions. May cross train to other department functions.
- Implementation of documentation and change control using the electronic documentation and change control software
- Cross train on additional software including JD Edwards, Master Control, Microsoft Word, Access, Excel, Harrington, Microsoft Teams and One Drive
- May participates in FDA, Corporate, and internal audits
- Data analysis and system report running
- This position requires participation as an active team member ensuring compliance to regulations, internal and external policies and procedures. Responsibilities also include the processing of requested changes. Change Control Coordinator is responsible for the maintenance of controlled documentation and supporting systems. Change Control Process- update procedures using Word / Excel, ensure formatting is correct and verify internal and external references. SOP's, work instructions, create links, assign approvers, etc. follow checklists, verbal and written direction. Will not be writing documents, will verify that data entry fields are accurate. Works on straightforward tasks using established procedures; work is subject to review by others. Good attention to detail is a must. Ability to work in a team environment and to communicate clearly and effectively. Ability to multi-task and priortize work load. Positive and Professional attitude. Experience in a documentation related position preferably in a FDA and/or regulated environment. Experience in Electroni Document Management Systems, Master control is preferred.
- Medical Device Industry experience a plus.
- Experience in a regulated environment preferred, such as FDA, ISO.. etc.
- Minimum of an Associate's Degree Bachelor's degree highly preferred.
- *al candidates, looking to fill quickly.
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Document Control Assistant(Looking to Fill Quickly) - Tempe, United States - MILLENNIUMSOFT
Description
Position : Document Control Assistant(Looking to Fill Quickly)
Location : Tempe, AZ
Duration : 12 Months Contract
Total Hours/week :40.00
1st shift
Description:
