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.
- 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.
- Minimum of a Bachelor's, equivalent University Degree
Experience and Skills:
- Minimum 4 years of relevant work experience
- Proficient in Microsoft Suite (Outlook, Word, Excel, and PowerPoint)
- Confirmed understanding of electronic documentation systems, data retrieval and electronic file formats – Direct experience with Agile PLM
- Ability to collaborate in an open office environment and remotely with virtual teams while paying attention to detail
- Work successfully and in coordination with others and other departments in achieving organizational goals
- Ability to coordinate, prioritize, and balance multiple projects and tasks simultaneously
- Strong analytical, prioritization, communication, and leadership skills
- Proven experience/knowledge with managing parts/BOM structures/drawings
- Ability to work independently without supervision and in a team
- Prompt in reporting for work and effectively and efficiently uses their time to accomplish their job tasks
- Ability to meet project achievements and work in a fast-paced environment
- Experience with Product Lifecycle Management (PLM) systems, such as Agile PLM, ADAPTIV (Enovia platform), Windchill, and/or equivalent PLM systems within a regulated industry
- Familiarity and ability to apply Good Manufacturing Practices (GMPs) documentation requirements, especially pertaining to quality records and change control
- Medical Device, Pharmaceutical, and/or Biotech experience
- An understanding of FDA 21 CFR 820, ISO 13485 documentation requirements, especially pertaining to document control, training, quality records, and process control is preferred.
- Experience with MRP/ERP systems such as SAP
- This position is located in Redwood City/Santa Clara, CA, and requires less than 10% domestic travel.
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .]