Records & Document Control Administrator

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.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Documentation

Job Category:

Professional

All Job Posting Locations:

Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

• About MedTech

  Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

  Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

  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.jnj.com/. 

  This is a field-based role available in all cities within Pennsylvania. 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 any location to apply.

  We are searching for the best talent for Records & Document Control Administrator.

  Purpose:

• Accountable for support and maintenance of the Records Management Program. Manages records systems and user access, supports the maintenance of Site Records Inventory Lists (RIL), and ensures archive records are identified per requirements.
• Accountable for administration of the Document Change Request/Change Notice (CR/CN) process in Windchill.
• Accountable for compliance with the Food and Drug Administration's (FDA) Quality System Regulation (QSR) as it pertains to Records Management and Document Control.
• Responsible for translating regulatory standards and business processes into documented quality systems, as related to Records Management and Document Control processes.

• You will be responsible for:

• Provides Records Management oversite for specified DePuy and Synthes locations (up to 50%).
• Ensure that archived records are identified, tracked, and stored according to requirements.
• Recruits, trains, coaches and maintains a list of department Records Coordinators
• Develops and conducts effective local records management communication and training deployed throughout the business.
• Coordinates the review, maintenance, accuracy and integrity of the site Record Inventory Lists, including vital records.
• Evaluate vital records protection requirements and implement consistent solutions for record protection.
• Implement and maintain RIM systems, websites and file share locations.
• Manage archive records in RIM-managed on-site and off-site storage facilities.
• Manage access to offsite storage locations.

• EXPERIENCE AND EDUCATION

• University Bachelor’s Degree or equivalent is required.
• Minimum 3-4 years experience working in a GMP, ISO or similar regulated environment is required.
• Previous experience in Records Management, Document Control, or actively managing Quality or Manufacturing controlled documents or records in a GMP and/or ISO regulated industry is strongly preferred.
• Medical device, Pharm