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Regardless of your race, belief, sexual orientation, religion or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world._
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**COMPANY**
**CHANGE CONTROL ANALYST I**
**JOB SUMMARY**
The Change Control Analyst will play an important role in executing the change control processes for changes to Device Master Records, Quality System Record data, and/or documents in the Product Lifecycle Management (PLM) system, providing internal customers with guidance in following change control procedures and ensuring changes conform to established standards.
**DUTIES AND RESPONSIBILITIES**
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will be responsible for the following:
- Review document changes submitted for accuracy and consistency with other documents.
- Review changes and implementation plan based on the description/rationale and the sites/functions affected.
- Analyze Change Orders and submit for approval in a timely manner.
- Proofreads and edits documents for style, grammar, spelling, format and impact it may have on other documentation.
- Provide guidance to change originators, system users, and other internal customers in change control processes and system tools.
- Assist in conducting internal audits of the change management process.
- Verify change implementation and approves closure of completed change orders.
- Collaborate with relevant personnel to ensure accuracy of any document revisions.
- Support process improvements and assist in implementation.
- Provide support during internal and external audits.
- Generate reports and metrics on the change process as needed.
- Other responsibilities may be assigned and not all responsibilities listed may be assigned.
- 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.
**Calificaciones**
EXPERIENCE AND EDUCATION**
- High School Diploma and/or technical career.
Desirable, 50% of college career and related work experience.
- 0-2 years of experience related to the position or close to 50% completion of a Bachelor degree (Preferably).
- Knowledge and skills to satisfactory develop the position responsibilities.
**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).
- Experience in Electronic change control processes and PLM systems (i.e.
cPDM, ADAPTIV (Enovia platform), Windchill PLM, 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.
- Strong analytical and decision-making abilities.
**LOCATION**: Juárez, México
**Ubicación principal**
México-Chihuahua-Ciudad Juárez
- **Organización**
Cordis de Mexico S.A. de C.V. (8286)
**Área**
Calidad
**Requisition ID**
2206018318W