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Documentation Specialist II - United States  

Company managed [?] Still accepting applications

Posted on : 22 December 2017

Project Description

Document Control ensures cGMP documents used at multiple client's manufacturing sites are correct, consistent, and functional. The Document Control team also maintains master versions of SOPs, production and control records, and facilitates associated life-cycle activities in compliance with company standards. Document Control creates and presents training, and provides guidance to documentation systems users. The department objective is to adhere to the highest quality and safety standards while supporting the multi-faceted needs of a fast-paced and deadline-driven organization.
Facilitate the lifecycle of controlled documents in the electronic document management system (document creation revision, and obsoletion).
Execute cGMP standard operating procedures while adhering to all company quality standards and requirements.
Assess for accuracy and process Document Change Request workflows. Demonstrate expertise in Microsoft Word and other Microsoft Office applications to meet established document formatting requirements.
Execute supplementary cGMP department activities in support of site operations.
Exercise professional written and verbal communications skills in supporting customer and team member needs.
Develop subject matter expertise for all department systems and processes.
Contributor on cross functional project teams.

preferred qualifications
Strong organizational skills and attention to detail.
Strong written and verbal communications skills.
Team oriented and customer friendly.
Proficient in Microsoft Word.
2-3 years experience using electronic document and records management systems.
2-3 years experience working in a cGMP environment.
Experience leading cross-functional project teams.

High School diploma/GED and 2-3 years experience working in a Document Control, Quality Systems, or cGMP environment, or, Bachelor's degree with no prior experience.