Document Control & Records Change Specialist (PLM)

Biopharma Careers; Ciudad Juárez; Presencial; MXN 300.000 - 420.000; Jornada completa

Descripción de la vacante

Johnson & Johnson seeks a Document Control Change Analyst to ensure proper change control execution for Quality System documents and PLM entries. You will guide internal customers on change control procedures and records management, ensuring adherence to standards.

You will analyze changes, review requests, proofread, translate policies as needed, and support audits while collaborating across functions to maintain accuracy and compliance.

Formación

• Education: High School Diploma or technical career, near completion of college or related experience.
• Experience: 4–6 years in document control or related area.
• Bilingual English/Spanish required.
• Proficient in Microsoft Office.
• Experience with PLM systems in regulated industry (e.g. Windchill, ADAPTIV).
• GMP/ISO knowledge preferred.
• Strong communication and organizational skills.

Responsabilidades

• Analyze documentation changes based on description/rationale and sites/functions affected.
• Review accuracy and consistency of document changes submitted.
• Review Change Requests/Change Notices in a timely manner.
• Proofread and edit documents for style, grammar, spelling, format, GDP compliance.
• Complete Quality System policy and procedure translations as required.
• Collaborate with relevant personnel to ensure accuracy of document revisions.
• Provide training to change originators and system users in change control processes.
• Execute and support Records Management program activities.
• Generate Document Change Control/Records Management reports as needed.
• Support Quality Systems audits (FDA, ISO, internal).
• Follow Environmental, Health & Safety policies and procedures.

Conocimientos

Bilingual EN/ES

MS Office

Attention to detail

Communication skills

Educación

High School Diploma / Technical Career

Herramientas

Windchill

ADAPTIV

Descripción del empleo

Johnson & Johnson seeks a Document Control Change Analyst to ensure proper change control execution for Quality System documents and PLM entries. You will guide internal customers on change control procedures and records management, ensuring adherence to standards.

You will analyze changes, review requests, proofread, translate policies as needed, and support audits while collaborating across functions to maintain accuracy and compliance.