Documentation Coordinator II

Job Title:             Associate Documentation Support

FLSA Status:       Non-Exempt

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.

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.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

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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