Quality System Document Control

InotivWest Lafayette, IN
1d$49,100 - $60,400Remote

About The Position

This position provides professional and efficient support to the document control team, including receiving, reviewing, categorizing, posting, filing and tracking documents. Key Accountabilities General Interact with global stakeholders and employees at all levels of the organization to facilitate completion of document reviews and approvals. Ensure documents comply with company standards and applicable procedures. Follow all applicable company procedures. Maintain confidential information. Support the use of the Inotiv documentation control system. Support any special projects assigned to the document control team as requested. Other special projects and duties as assigned. Specific Work with internal stakeholders to create, revise, review, and release requested documents. Ensure the proper formatting of documents before approval in the document control system. Track and manage document lifecycle activities as required by the document control system. Prepare and route documents for review and/or approval. Convert documents to appropriate format for general distribution and use. Prepare and distribute documents for release for use. Remove obsolete documents from use and archive for retention. Mentor and assist document owners and users in the execution of the document control process. Update and maintain documentation master lists and other applicable tracking tools. Support implementation and maintenance of QMS document control software application.

Requirements

  • Bachelor’s Degree, preferably in English or technical writing discipline, with minimum of 1 year work experience OR 2+ years direct work experience in technical writing or document management within a scientific and/or regulated industry. Equivalent combination of related education and required work experience will be considered.
  • Ability to read, write, speak, and understand English.
  • Organized work habits and the ability to multi-task is required.
  • Strong understanding of detailed requirements, methodology, and approach for managing and controlling documents within a formal QMS.
  • Proficient in the use of computer applications including MS Word, MS Excel, MS Teams, MS Outlook, SharePoint and Adobe Acrobat.
  • Ability to communicate and resolve document control issues with document owners and approvers.
  • High attention to detail.
  • Ability to work on multiple tasks and prioritize work.
  • Excellent verbal and written communication skills.

Responsibilities

  • Interact with global stakeholders and employees at all levels of the organization to facilitate completion of document reviews and approvals.
  • Ensure documents comply with company standards and applicable procedures.
  • Follow all applicable company procedures.
  • Maintain confidential information.
  • Support the use of the Inotiv documentation control system.
  • Support any special projects assigned to the document control team as requested.
  • Work with internal stakeholders to create, revise, review, and release requested documents.
  • Ensure the proper formatting of documents before approval in the document control system.
  • Track and manage document lifecycle activities as required by the document control system.
  • Prepare and route documents for review and/or approval.
  • Convert documents to appropriate format for general distribution and use.
  • Prepare and distribute documents for release for use.
  • Remove obsolete documents from use and archive for retention.
  • Mentor and assist document owners and users in the execution of the document control process.
  • Update and maintain documentation master lists and other applicable tracking tools.
  • Support implementation and maintenance of QMS document control software application.

Benefits

  • health and dental coverage
  • short- and long-term disability
  • paid time off
  • paid parental leave
  • 401K
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