Position                       : Electronic Document Management System

Location                     : Tempe, AZ

Duration                     : 6 Months Contract

Total Hours/week      : 40.00

1^st 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.