Document Control Specialist

hace 3 semanas

Oaxaca, Oaxaca, México Johnson & Johnson A tiempo completo

Job Summary:

The Document Control Change Analyst plays a critical role in ensuring the accuracy and consistency of Quality System documentation and records management processes within Johnson & Johnson. This position is responsible for analyzing documentation changes, reviewing accuracy and consistency, and providing guidance to internal customers on document change control and records management procedures.

Key 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 edit 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.

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 a >75% completion of a bachelor's degree.
  • 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.

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