Document Control Specialist

Johnson & Johnson Redwood City , CA 94063

Posted 1 week ago

Robotics & Digital Solutions, part of the Johnson & Johnson Family of companies, is recruiting for a Document Control Specialist located in Redwood City/Santa Clara, CA.

Robotics & Digital Solutions is part of Ethicon, Inc., a global leader in surgery with products and solutions found in almost every operating room around the world. Ethicon has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our dedication to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com

The Specialist will play an important role in implementing the document and change control processes for changes to Documents and Records in PLM systems such as Agile PLM. This role is responsible for providing internal customers with mentorship in following document and change control procedures.

Key Responsibilities:

  • Facilitate the change control process from initiation through all workflows steps to implementation including review of completed change orders for content and the approvals.

  • Collaborate and provide mentorship to change owners, approvers, and business partners.

  • Review change orders and items for completeness and compliance with QSR, ISO and internal template and procedure requirements in a timely manner.

  • Perform final incorporation of documentation revisions and pre-release preparation of the document files associated with approved change orders and ensure workflow activities are completed.

  • Coordinate with end users regarding problems in accessing electronic content

  • Select and/or verify required approvers of changes per procedures.

  • Assist in the preparation of document control metrics and reports, including but not limited to periodic review process and change order timeliness

  • Communicate the status of changes.

  • Support and recommend change control process improvements including initiating procedural revisions.

  • Support both internal and external audits, as well as quality events (CAPA, NC, Audit findings), relating to document/change control processes.

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