Document Control Change Analyst Senior

hace 1 semana

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 **Document Control Change Analyst Senior** to be in **Ciudad Juarez, Chihuahua **.

**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.

**DUTIES & 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:

- 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**:
**EDUCATION**:
High School Diploma and/or technical career. Close to completion of college career or recently finished and related work experience required.

**EXPERIENCE**:

- 4-6 years 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).
- 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 com

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