At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered.
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, solutions and help people live longer, healthier lives.
And you can be part of it too.
Whith Ethicon
**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.
**Responsibilities**
- 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.
**Ideal Requirements**
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 75% completion of a bachelor's degree
- Bilingual or Fluent in English / Spanish required.
- 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.
- Ability to organize, prioritize, and handle multiple projects simultaneously.
- This position travels infrequently.
Tipo de puesto: Tiempo completo, Por obra o tiempo determinado
Duración del contrato: 18 meses
Salario: $13,000.00 - $13,100.00 al mes
Horario:
- Turno de 8 horas
Consideraciones ante el COVID-19:
Mascarilla, desinfección, medidas de Seguridad e Higiene de acuerdo a las regulaciones estatales y federales
Puede trasladarse/mudarse:
- 32599, Juárez, Chih.
: Trasladarse al trabajo sin problemas o planear mudarse antes de comenzar a trabajar (Obligatorio)
Educación:
- Técnico superior terminado (Obligatorio)
Experiência:
- Document Control Change Anayst: 2 años (Obligatorio)
Idioma:
- Inglés Avanzado (Obligatorio)
Disponibilidad para viajar:
- 50 % (Deseable)