En Johnson & Johnson, la compañía de cuidado de la salud más grande del mundo, nos unimos con un propósito: transformar la historia de la salud en la humanidad.
La diversidad y la inclusión son esenciales para continuar construyendo nuestra historia de pioneros e innovación, que ha estado impactando la salud de más de mil millones de pacientes y consumidores todos los días durante más de 130 años. Independientemente de su raza, creencia, orientación sexual, religión o cualquier otro rasgo, TÚ eres bienvenido en todos los puestos vacantes en la compañía de cuidado de la salud más grande del mundo.
Cuando te unes a Johnson & Johnson, tu movimiento podría significar nuestro próximo avance.
En Johnson & Johnson Medical Devices Companies, utilizamos nuestro alcance, escala y experiência para reinventar la manera en que se brinda atención médica y ayudar a las personas a vivir más tiempo y de manera más saludable.
En un entorno sumamente cambiante, establecemos conexiones entre la ciencia y la tecnología para combinar nuestros propios conocimientos especializados en soluciones quirúrgicas, ortopédicas e intervencionistas a fin de diseñar y ofrecer productos y servicios centrados en el paciente.
Estamos en esto de por vida.
Estamos cambiando la trayectoria de la salud humana, TU TAMBIÉN PUEDES.
JOB SUMMARY*
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. o Compliance with safety policies and procedures. o 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**:
EXPERIENCE AND EDUCATION*
High School Diploma and/or technical career.
Desirable, 75% of college career and related work preferred.
2-4 years of experience related to the position or a >75% completion of a bachelor's 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., 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