Analyst Ii Change Control

hace 3 semanas

Ciudad Juarez, México Johnson & Johnson A tiempo completo

At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.

Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. 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.

When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough. At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives. In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions. We are in this for life. We are changing the trajectory of human health, **YOU CAN TOO.**

**We are searching for the best talent for ANALYST II CHANGE CONTROL to be in Juarez.**

**Purpose**:
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.

**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 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.

**Qualifications**:
Qualifications and requirements:

- High School Diploma and/or technical career.
- Desirable, to be close to finish a college career or recently finished.
- 2-4 years of experience related to the position or a >75% completion of a Bachelor 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).
- 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.

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