ANALYST II CHANGE CONTROL

Johnson & Johnson; Chihuahua; Presencial; MXN 538,000 - 809,000; Jornada completa

Descripción de la vacante

A global healthcare leader in Ciudad Juarez, Chihuahua, is seeking an Analyst II Change Control to conduct quality assurance inspections and manage document control processes. The ideal candidate should be bilingual in English and Spanish, have at least 6 years of relevant experience, and possess strong organizational and communication skills. This role supports the Quality Systems initiatives to enhance care and ensure compliance with regulations.

Formación

• 6+ years of experience related to position preferred.
• Knowledge of GMP/ISO standards preferred.
• Ability to work collaboratively with a team.

Responsabilidades

• Conduct quality assurance inspections.
• Analyze documentation changes based on the description/rationale.
• Review Change Requests/Change Notices in a timely manner.

Conocimientos

Bilingual or Fluent in English / Spanish

Microsoft Office proficiency

Strong verbal, written and active listening skills

Ability to organize and prioritize

Educación

High School Diploma or technical career

Close to completion of college career or related work experience

Herramientas

Product Lifecycle Management (PLM) systems

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 https://www.jnj.com

Job Function

Quality

Job Sub Function

Quality Control

Job Category

Business Enablement/Support

All Job Posting Locations

Ciudad 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 Cardiovascular: 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 Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. 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 Analyst II Change Control to be in Cd. Juarez, Chih. at Plant Salvarcar.

Purpose

• Responsible for conducting complex quality assurance inspections.
• Uses results, considerable judgment, and initiative to improve production processes and standards.
• 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:

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & J&J, 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 edit 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

• High School Diploma and/or technical career. Close to completion of college career or recently finished and related work experience required.
• Generally, requires 6 years or more of experience related to the position or close to completion of a bachelor’s degree (Preferably).
• Knowledge and skills to satisfactorily develop the position responsibilities.
• 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.

Preferred Skills

Administrative Support, Communication, Compliance Management, Controls Compliance, Execution Focus, ISO 9001, Persistence and Tenacity, Problem Solving, Quality Control (QC), Quality Standards, Quality Systems Documentation, Quality Validation, Report Writing, Standard Operating Procedure (SOP), Teamwork, Technologically Savvy.