Electronic Document Management (Must Have FDA, ISO & JD Edwards)

Position :  Electronic Document Management System

Location : Tempe, AZ

Duration : 6 Months Contract

Total Hours/week : 40.00

1st shift

Description:

Job Description Summary:

· 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 prioritize work load. Positive and Professional attitude. Experience in a documentation related position preferably in a FDA and/or regulated environment.

· Experience in Electronic Document Management Systems, Mastercontrol is preferred.

Qualifications:

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.