Document Management Specialist

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

Job Function:

Quality

Job Sub Function:

Quality Documentation

Job Category:

Professional

All Job Posting Locations:

Palm Beach Gardens Florida United States of America Raynham Massachusetts United States of America 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 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:

Palm Beach FL

Warsaw IN

Raynham MA

West Chester PA

We are searching for the best talent for a Document Management Specialist to be in Raynham MA.

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 () or contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

Between $64600.00 and $87400.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees and/or eligible dependents are 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. Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys 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 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 Condolence Leave 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours Additional information can be found through the link below. Experience:

IC