Demo

Document Controller

ISEE Careers
Brunswick, NJ Full Time
POSTED ON 4/21/2025
AVAILABLE BEFORE 5/20/2025

About the job Document Controller

Company Overview

The Company develops, manufactures, and markets in-vitro diagnostics (IVD) tests.

Responsibilities

  • Develop and implement production processes related to document control and management
  • Collect and register all technical document, such as drawings and blueprints in the Companys system
  • Review and update documents for maintenance and quality control
  • Keep other personnel updated on new document versions and how to obtain access
  • Handle records across various departments
  • Create templates for use by other personnel
  • Maintain confidentiality regarding sensitive documents
  • Establish and maintain record-retention timelines
  • Generate and / or revise SOPs, QF, and QOP used for the Production Team
  • Respond and communicate with all levels of production personnel, as well as other departments regarding documents and their control
  • Correspond with and coordinate all activities related to documents
  • Manage new machine validation procedures, including reviewing the validation protocols and generated data

Requirements

  • BA or BS degrees, or an equivalent
  • Bilingual (Korean and English)
  • Strong communication skills with supervisors and other department personnel
  • Understand production process lines
  • Ability to generate product-related documents effectively
  • Having good knowledge and training in GMP / QMS is a must
  • Benefits

  • Health, Dental & Vision
  • 401(k)
  • Incentives
  • Relocation Assistance
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