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