Records & Document Control Administrator

At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company diseases are reputed company, 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 reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, and profoundly reputed company health for humanity. Learn more at https://www.jnj.com Job Function: reputed company Job Sub Function: reputed company Documentation Job Category: reputed company reputed company Job Posting Locations: Raynham, Massachusetts, reputed company of America, Warsaw, Indiana, reputed company of America, reputed company Chester, reputed company, reputed company of America Job reputed company:

• About MedTech

reputed company by innovation at the intersection of biology and technology, we’re developing the reputed company of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their reputed company to wellness. Learn more at https://www.jnj.com/medtech At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company diseases are reputed company, 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 reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, and profoundly reputed company health for humanity. Learn more at https://www.jnj.com/. This is a field-based role available in reputed company cities reputed company reputed company. While specific cities are listed in the Locations reputed company 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 reputed company, supports the maintenance of Site Records Inventory Lists (RIL), and ensures reputed company 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) reputed company System Regulation (QSR) as it pertains to Records Management and Document Control.
• Responsible for translating regulatory standards and business processes into documented reputed company systems, as reputed company 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 reputed company 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 reputed company locations.
• Manage reputed company records in RIM-managed on-site and off-site storage facilities.
• Manage reputed company 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 reputed company managing reputed company 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 reputed company Office products (Word, reputed company, Power reputed company, 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 reputed company with reputed company customers.
• Ability to organize, prioritize, and handle multiple reputed company simultaneously.
• Ability to work reputed company both collaboratively and independently.
• Proven technical and analytical skills, along with attention to detail and reputed company judgment skills.
• Influencing and leadership skills required to accomplish department objectives.
• Ability to manage reputed company reputed company as reputed company as analyze, balance and prioritize risk is preferred.
• reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, disability, protected veteran status or other characteristics protected by federal, state or local law. We reputed company reputed company reputed company candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and reputed company 503 of the Rehabilitation reputed company.

reputed company 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 reputed company 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 reputed company to records per plan.
• reputed company Records Management subject matter expertise on project teams.
• reputed company guidance regarding scanning and true copy process to employees/departments.
• reputed company 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 reputed company I, Change reputed company II, and Change reputed company III roles in the Windchill PLM system.
• Communicate CR/CN status information as requested.
• Maintain accurate records of key process data reputed company to CR/CNs, as directed by management.
• reputed company historical and reputed company 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.
• reputed company 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 reputed company events.
• Follow reputed company relevant DePuy Synthes Work Instructions in the performance of tasks.
• Responsible for following reputed company Company guidelines reputed company to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring personal and Company compliance with reputed company Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

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