Document Controller Coordinator

Position: Document Controller Coordinator I
Location: Germany

Document Controller Coordinator I page is loaded## Document Controller Coordinator Ilocations:
Gelang Patah, Johortime type:
Full time posted on:
Posted Todayjob requisition :
REQ-Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
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* Position Overview:

** The Associate Documentation will work under the guidance of the Quality Assurance Manager to maintain the Document Control System to ensure control, security, integrity, non-and availability of documentation to site personnel.  This person is responsible for implementing and maintaining document control and record retention for the site. This person is responsible for control of documents and coordination of controlled document related activity pursuant to GMP/ISO regulations.
** Responsibilities:
*** Maintain DHR documentation database.
* Control the flow of DHR documents to support lot release, as required.
* Create and update documentation for DHR files & logs.
* Filing and other organizational tasks.
* Perform Lot Release.
* Conduct internal quality audits, as required.
* Data input into the Insulet computer system.
* May provide guidance to other staff.
* Performs other duties as required.
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* Education and Experience:

*** 2 years of experience maintaining documents within a QC or GMP/ISO-certified environment preferred, or more than 6 months experience with Quality, Training or records management and/or equivalent combination of education and experience.
* Demonstrated knowledge of Microsoft Office, including Access.
* Knowledge of Microsoft Word.
* Knowledge of Configuration Data Management requirements for engineering documentation a plus but is not required.
* Working knowledge of documentation functions of a medical device company preferred.
* Familiarity with ERP (e.g., MFG/Pro) is a plus, but is not required.
* Any Quality certifications a plus.
** Skills/

Competencies:

*** Effective written and verbal communication skills.
* Ability to communicate at all organizational levels.
* PC skill, word processing.
* Ability to organize and judge priorities.
* Ability to generate and maintain accurate records.
* Comfortable communicating to all levels and functions.
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