Document Control Change Analyst Principal

Johnson Johnson; Ciudad Juárez; Presencial; MXN 450.000 - 650.000; Jornada completa

Descripción de la vacante

Johnson & Johnson in Ciudad Juarez seeks a Document Control Change Analyst Principal to ensure proper execution of change control for Quality System documentation within the PLM system. You will support the Records Management program and guide internal customers in change control processes.

The role emphasizes collaboration across functions, accuracy of revisions, and participation in GMP/GDP compliant practices, with responsibilities spanning translations and audits.

Formación

• EDUCATION: High School Diploma and/or technical career. Close to completion of college career or recently finished and related work experience required.
• EXPERIENCE: 6 years or more 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.

Responsabilidades

• Analyze documentation changes based on description and site impact.
• Review accuracy and consistency of document changes submitted.
• Review Change Requests/Change Notices in a timely manner.
• Proofread and edit documents for style, grammar, spelling, format, ensuring GDP alignment.
• Translate Quality System policy and procedures as required.
• Collaborate with personnel to ensure accuracy of document revisions.
• Provide training to change originators and system users in change control processes.
• Support Records Management program activities.
• Generate document change control/records reports.
• Support quality systems audits (FDA, ISO, internal).

Conocimientos

Six years experience

Documentation knowledge

Change control proficiency

Quality Systems understanding

Educación

High School Diploma/Technical Career

Close to college completion or recent degree

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:

Professional

All Job Posting Locations:

Juarez, Chihuahua, Mexico

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 DOCUMENT CONTROL CHANGE ANALYST PRINCIPAL 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.

Responsibilities:

• 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: 6 years or more 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