Description
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:
Supply Chain ManufacturingJob Sub Function:
Manufacturing Process ImprovementJob Category:
Business Enablement/SupportAll Job Posting Locations:
Ciudad Juarez, Chihuahua, MexicoJob 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
We are searching for the best talent for Document Control Change Analyst II to be in Ciudad Juarez, Independencia plant.
You will be responsible for:
In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
• Analyze documentation changes based on the description/rationale and the sites/functions affected.
• Review accuracy and consistency of document changes submitted.
• Review Change Requests/Change Notices in a timely manner.
• Proofread and edits documents for style, grammar, spelling, format, ensuring appropriate GDPs.
• Complete Quality System policy and procedure translations as required.
• Collaborate with relevant personnel to ensure accuracy of document revisions.
• Provide training/guidance to change originators, system users, and other internal customers in change control processes and system tools.
• Execute and support activities associated with Records Management program/procedures. • Generate Document Change Control/Records Management reports as needed.
• Support implementation of Quality Systems initiatives and process improvements as required.
• Support Quality Systems audits; FDA, ISO/ TUV, Internal, etc.
• Other responsibilities may be assigned and not all responsibilities listed may be assigned.
• Compliance with safety policies and procedures.
• Ensures compliance with Environmental Management System (EMS) responsibilities.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if 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
Qualifications / Requirements:
- High School Diploma and/or technical career. Desirable, 75% of college career and related work preferred.
- 2-4 years of experience related to the position or a >75% completion of a bachelor’s degree. (Preferably)
- Bilingual or Fluent in English / Spanish required.
- Computer skills and proficiency in Microsoft Office (i.e., Word, Excel, PowerPoint, E-mail).
- Ability to learn software applications associated with Document & Data Control (Product Lifecycle Management - PLM system).
- Experience in Electronic change control processes and PLM systems (i.e., Windchill, ADAPTIV, etc.) in a regulated industry is highly desirable.
- GMP/ ISO knowledge preferred.
- Strong verbal, written and active listening skills.
- Ability to organize, prioritize, and handle multiple projects simultaneously.
- Ability to communicate effectively and in a professional manner with all levels of the organization and with different functional groups.
- Ability to perform duties in accordance with policies and procedures complying with applicable requirements.
Required Skills:
Preferred Skills:
Agile Manufacturing, Analytical Reasoning, Communication, Data Reporting, Detail-Oriented, Equipment Maintenance, Good Manufacturing Practices (GMP), Innovation, Materials Handling, Package and Labeling Regulations, Package Equipment, Packing Orders, Plant Operations, Process Oriented, Product Packaging Design, Professional Ethics, Quality Assurance (QA), Teamwork, Validation Testing