Document Control Change Analyst Principal

Johnson And Johnson; Ciudad Juárez; On-site; MXN 380,000 - 520,000; Full time

Job summary

Johnson & Johnson in Ciudad Juárez seeks a seasoned Document Control Change Analyst Principal for Ethicon. You will ensure correct execution of change control for Quality System documentation and PLM, supporting Records Management and training users in change control processes.

Qualifications include a high school diploma or technical training, 6+ years of related experience, and bilingual English/Spanish. Proficiency with Windchill/ADAPTIV is preferred.

Qualifications

• High School Diploma and/or technical career.
• Close to completion of college career or recently finished and related work experience required.
• 6+ years of experience related to the position preferred.
• Fluent in English and Spanish.

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.

Skills

Bilingual English/Spanish

MS Office proficiency

Detail-oriented

Strong communication

Education

High School Diploma / Technical Career

College coursework near completion

Tools

Windchill PLM

ADAPTIV PLM

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empower us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

You will be responsible for: In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & J and 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.
• 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/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