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, Pharmaceutical and/or Biotech experience is preferred.
• REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS
• Proficiency with Microsoft Office products (Word, Excel, Power Point, etc.) is required.
• Proficiency in Windchill PLM is preferred.
• Proficiency with various PC-Based CAD systems (Pro/Engineer, AutoCAD, etc.) is preferred
• Above average written and verbal communication skills.
• Ability to effectively interact with internal and external customers.
• Ability to organize, prioritize, and handle multiple projects simultaneously.
• Ability to work well both collaboratively and independently.
• Proven technical and analytical skills, along with attention to detail and sound judgment skills.
• Influencing and leadership skills required to accomplish department objectives.
• Ability to manage complex projects as well as analyze, balance and prioritize risk is preferred.
• 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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

• Support the systematic reduction of eligible records by assisting in the development and implementation of regularly scheduled records review, approval, and destruction of offsite records.
• Conduct assessment of offsite vendor per requirements.
• Support acquisition or divestiture related to records per plan.
• Provide Records Management subject matter expertise on project teams.
• Provide guidance regarding scanning and true copy process to employees/departments.
• Provide litigation support for company records.
• Supports the Document and Change Control process (up to 50%)
• Accountable that Synthes Change Requests (CR) and Change Notices (CN) are reviewed for completeness, accuracy and compliance with applicable policies and procedures. Performs the Change Admin I, Change Admin II, and Change Admin III roles in the Windchill PLM system.
• Communicate CR/CN status information as requested.
• Maintain accurate records of key process data related to CR/CNs, as directed by management.
• Provide historical and current documentation in response to audits, legal requests, queries from management and other departments as needed.
• * Applies in-depth knowledge of records management and document control to maintain policies, procedures, work instructions, training materials, and records.
• Provide records, document and change control backroom and logistical support for audits and inspections as needed
• Supports actions and effectiveness monitoring activities associated with CAPAs, NCs, observations, and other quality events.
• Follow all relevant DePuy Synthes Work Instructions in the performance of tasks.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

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