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Document Control Coordinator

3 months ago

Plainsboro, New Jersey, United States Integra LifeSciences Full time

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.

RESPONSIBILITIES

  • Responsible for supporting the maintenance of the document control system during 2nd shift
  • Responsible for formatting, proper spelling and clarity of text for any written documents submitted to
    document control.
  • Review all electronic documents submitted to document control for correct formatting, spelling and clarity of
    text before releasing as approved documents.
  • Maintains all ISO/FDA standard operating procedures, work instructions and forms.
  • Maintains revision and approval status of all documents.
  • Maintains hard copies of all approved documentation.
  • Maintains appropriate templates for access.
  • Tracking, follow-up and implementation of, including but not limited to, ECRs, DCRs, ECOs, DCOs, MCOs.
    deviations, validation records, batch records and notebooks.
  • Responsible for processing change orders through the Agile PLM system.
  • Support internal audits when needed
  • Supports external audits when needed
  • Issues controlled documentation such as batch record and validations

QUALIFICATIONS

  • Minimum high school diploma
  • Minimum of 1-2 years' experience in document and promotional materials management using electronic
    document management systems or with manual systems using electronic document storage.
  • Minimum of 1-2 years' experience in a Quality Systems I Regulatory Compliance environment with a
    working knowledge preferably in the medical device, diagnostics or pharmaceutical industries. Familiarity
    with FDA regulations and ISO series of quality standards preferred.
  • Capable of both written and verbal effective communication skills.
  • Proficient in the Microsoft Office suite of products.
  • Proficient in Oracle R12/Agile preferred.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
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