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
• PTO
• 401(k)
• Incentives
• Relocation Assistance