SENIOR DOCUMENT CONTROL CHANGE ANALYST (Fixed Term: 12 months)

8283-EES S.A de C.V. Legal Entity; Ciudad Juárez; Presencial; MXN 279.000 - 502.000; Jornada completa

Descripción de la vacante

Johnson & Johnson in Ciudad Juárez seeks a Senior Document Control Change Analyst to ensure correct execution of change control for Quality System documentation and PLM records.

The role requires 4–6 years of related experience, bilingual English/Spanish, and hands-on PLM system experience (Windchill, ADAPTIV). GMP/ISO knowledge is a plus, with collaboration across cross-functional teams.

Formación

• High School Diploma and/or technical career; close to college completion preferred.
• 4–6 years of related experience; bachelor’s near completion preferred.
• Bilingual English/Spanish required; strong communication skills.
• Experience with PLM systems (Windchill, ADAPTIV) in regulated industry; GMP/ISO knowledge is a plus.

Responsabilidades

• Analyze documentation changes based on description/rationale and affected sites/functions.
• Review accuracy and consistency of document changes submitted; timely response to Change Notices.
• Proofread and edit documents for style, grammar, and GDP compliance; translations as needed.
• Generate reports and support Records Management programs; assist audits (FDA, ISO) and process improvements.

Conocimientos

Bilingual (English/Spanish)

English/Spanish fluency

Educación

High School Diploma / Technical Career

Herramientas

Windchill

ADAPTIV

Descripción del empleo

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: Quality

Job Sub Function: Quality Control

Job Category: Business Enablement/Support

All Job Posting Locations: Juarez, Chihuahua, Mexico

Job Description: 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 About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. 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 SENIOR DOCUMENT CONTROL CHANGE ANALYST (Fixed Term: 12 months) for Ethicon in Ciudad Juarez.

Purpose: The role of the Document Control Change Analyst to ensure the correct execution of the change control processes for changes to Quality System documentation and/or documents in the Product Lifecycle Management (PLM) system, and to support the Site Records Management program. Provide internal customers with guidance in following document change control and records management procedures and ensuring adherence to established standards.

• 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.
• Follow J&J and EES Records Management Policies for Convenience Information, Records Retention Schedules, Training and Education.
• Responsible for communicating business related issues or opportunities to next management level.
• 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:

• EDUCATION: High School Diploma and/or technical career. Close to completion of college career or recently finished and related work experience required.
• EXPERIENCE: 4-6 years of experience related to the position or close to completion of a bachelor’s degree (Preferably). Knowledge and skills to satisfactory develop the position responsibilities required.
• REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*: 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. Ability to work collaboratively with a team or independently, with an eye for detail and methodical approach.
• Required Skills:
• Preferred Skills: Accountability, Administrative Support, Compliance Management, Controls Compliance, Execution Focus, ISO 9001, Persistence and Tenacity, Process Oriented, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Quality Validation, Report Writing, Teamwork, Technologically Savvy

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/.

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