Insulet Corporation

  • Documentation Specialist

    Job Locations US-MA-Billerica | US-MA-Billerica
    Posted Date 2 months ago(11/19/2018 11:15 AM)
    Category
    Regulatory Affairs / Clinical Affairs
  • Position Summary

    • The Specialist will work under the guidance of the Quality Assurance 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.

    Responsibilities

    • 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.
    • Lot Release of product DHF.
    • Performs other duties as required

    Education and Experience

    Minimum Requirements:

    • 1-3 years’ experience maintaining documents within a QC or GMP/ISO-certified environment preferred, or more than 2 years’ experience with Quality, Training or records management and/or equivalent combination of education and experience.

     

    Preferred Skills and Competencies:       

    • Demonstrated knowledge of Microsoft Office, including Access.
    • Expert 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.
    • 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

    Physical Requirements (if applicable):         

    • None

     

     

     

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