Document Management Specialist

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Documentation

Job Category:

Professional

All Job Posting Locations:

Leeds, West Yorkshire, United Kingdom, Raynham, Massachusetts, United States of America, Ringaskiddy, Cork, Ireland, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

 

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. 

 

 

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide.

 

This is a hybrid role available in multiple states within the US. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from various locations to apply and encourage you to review the following states where this opportunity is available:

Warsaw, IN

Raynham, MA

West Chester, PA

Leeds, UK

Cork, IRL

 

We are searching for the best talent for a Document Management Specialist.

 

Purpose: The Document Management Specialist will play an important role in executing the change control processes for changes to Device Master Records, Quality System Record data, and/or documents in the PLM system (Windchill), providing internal customers with guidance in following change control procedures.

 

You will be responsible for:

Executing change control processes related to the change control oversight of DePuy Synthes changes, including:

• Reviewing changes in a timely manner for compliance with procedures

• Selecting or verifying approvers of changes per procedures

• Collecting and reporting metrics pertaining to change control activities

• Communicating the status of changes

• Manage small projects that help support departmental objectives, including projects that require collaboration with other departments or facilities

• Support and recommend change control process improvements

• Support both internal and external audits, as well as quality events, relating to the change control processes

• Ensure all activities are in compliance with the documented quality system and current regulatory requirements.

 

Qualifications / Requirements:

Required:

• University/Bachelors Degree (or equivalent 4 year degree) plus a minimum of 1 year with electronic change control experience in regulated industry – medical device or pharmaceutical industry preferred

or

• Associate Degree (or equivalent 2year degree) plus a minimum of 3 years of business experience, including a minimum of 2 years with electronic change control experience in medical device or pharmaceutical industry

or

• A minimum of 5 years of business experience, including a minimum of 4 years with electronic change control experience in medical device or pharmaceutical industry

• Strict attention to detail and the ability to work in an open office environment and remotely with virtual teams

• Able to organize, prioritize, and handle multiple projects simultaneously

• Able to work independently and prioritize with little supervision

• Strong written and verbal communication and teamwork skills

• Proficient in Microsoft Outlook, Word, Excel, and PowerPoint

 

Preferred:

• Proficient in change control processes and Product Lifecycle Management systems - experience with Agile e6, ADAPTIV (Enovia platform), and/or Windchill PLM applications highly desired

 

This position may require up to 10% domestic and international travel.

 

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

 

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center  (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

Required Skills:

Communication, PLM Tools, SDLC Project Management

 

 

Preferred Skills:

Oracle Agile PLM

 

 

The anticipated base pay range for this position is :

$54,000.00 - $87,400.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are 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.



Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

Holiday pay, including Floating Holidays –13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits