Job Description

The Document Control Administrator is responsible for managing, organizing, and maintaining the plant documentation system to ensure compliance with internal policies and external regulations. This role involves overseeing document workflows, ensuring accuracy and accessibility, and supporting various teams in document-related processes. Job responsibilities include revising plant documents, writing Engineering Change Request/Orders, assisting ECR/O originators, updating the education system (C2C) and ensuring that the latest revision of all plant documents is made available on the shared network drive for the Canaan plant. Strong time management skills are essential, ensuring the ability to prioritize tasks effectively, meet deadlines consistently, and manage multiple responsibilities in a fast-paced environment without compromising accuracy or quality. Attention to detail is critical, ensuring accuracy and completeness in document management processes, identifying discrepancies or errors, and maintaining high standards of quality and compliance in all tasks. The Document Control Administrator must be able to make decisions independently and set own priorities based on business needs. Essential functions include managing document lifecycle activities, ensuring compliance with FDA 21 CFR Part 820 and ISO 13485, managing document revisions and version control, maintaining document management systems (SAP), facilitating document updates related to engineering changes, conducting audits and generating reports, training team members, and optimizing document control processes. Additional responsibilities include training system (C2C) administration and other duties as assigned. Minimum of 1 year experience in a similar role is required. Strong working knowledge of Microsoft Word, Excel, PowerPoint, databases/software packages, and interpersonal and communication skills are needed. Preferred experience includes regulated industry documentation, SAP, Access Databases, C2C Administration, and Visio. Minimum education required is a high school diploma or GED, with an associate degree preferred. The company prioritizes on-site collaboration with a minimum of 4 days in-office per week for most roles. Employment may be contingent on COVID-19 vaccination proof or testing as per company policy.

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