Insulet Corporation Sr. Documentation Specialist in Billerica, Massachusetts

The Specialist will work under the guidance of the Quality Document Control Manager to manage the Document Control System to ensure control, security, integrity 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.

  • Maintain documentation database.

  • Control the flow of documents to support manufacturing, as required.

  • Update procedures following ECO or engineers’ instructions and markups.

  • Create and update documentation master files & logs.

  • Filing and other organizational tasks.

  • Authors and revises QMS SOPs as required.

  • Assigns QMS training to site personnel

  • Develop/Organize/Maintain QMS Training Plans according to job function for site personnel

  • Performs other duties as required.

  • Bachelor’s degree with 3 – 5 years’ relevant experience and/or equivalent combination of education and experience.

  • Demonstrated knowledge of Microsoft Office, including Access.

  • Expert knowledge of Microsoft Word.

  • Working knowledge of documentation functions of a medical device company

  • Working knowledge of QMS SOP structure, linkage and best practices

  • Working knowledge of electronic documentation control and eQMS systems

  • Working knowledge of QMS Training systems and best practices

  • Familiarity with ERP (e.g. MFG/Pro) is a plus, but is not required.

  • 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.

  • Must have strong clerical skills (filing, alphabetization, etc.).

  • Very strong organizational skills.

  • Very strong attention to detail.

  • Able to work in a team environment.

External Company Name: Insulet Corporation

External Company URL: http://www.myomnipod.com/