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 & 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.
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 satisfactory 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.
Required Skills:
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
