DOCUMENT CONTROL SPECIALIST (1 OF 2)

Robotics & Digital Solutions, part of the Johnson & Johnson Family of companies, is recruiting for a Document Control Specialist to be located in Redwood City or Santa Clara, CA.
At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.
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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.
thicon.
om 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.
Coordinate with end users regarding problems in accessing electronic content Select and/or verify required approvers of changes per procedures.
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.
Qualifications Education.
University/Bachelor's degree or equivalent or equivalent years of experience required without degree and a high school diploma or equivalent.
Degree in a Science-related subject or other related field desired Experience and Skills.
Required.
Minimum two to four (2-4) years of relevant work experience required with degree; without degree six to eight (6-8) years of experience is required Proficient in Microsoft Suite (Outlook, Word, Excel, and PowerPoint) Confirmed understanding of electronic documentation systems, data retrieval and electronic file formats 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 Confirmed 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 uses their time to accomplish their job tasks Ability to meet project achievements and work in a fast-paced environment Preferred.
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 documentation requirements, especially pertaining to document control, training, quality records, and process control is preferred.
Experience with MRP/ERP systems such as SAP Other.
Up to 10% domestic travel.
The anticipated base pay range for this position is, in the Bay Area, is $ to $ The Company maintains highly competitive, performance-based compensation programs.
Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year.
Bonuses are awarded at the Company’s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs.
medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Employees are eligible for the following time off benefits.
Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below.
For additional general information on Company benefits, please go to.
https://www.
areers.
nj.
om/employee-benefits This job posting is anticipated to close on February .
The Company may however extend this time-period, in which case the posting will remain available on https://www.
areers.
nj.
om to accept additional applications.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.
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.