Document Controller

ISEE Career Solutions; New Brunswick (NJ); On-site; USD 55,000 - 75,000; Full time

Job summary

A healthcare solutions company in New Jersey is seeking a candidate to manage document control processes within their production team. Responsibilities include developing production processes, collecting technical documents, and coordinating activities related to document management. The ideal applicant is bilingual in Korean and English, has a BA or BS degree, and is familiar with production process lines and GMP/QMS standards. This role is vital for ensuring document accuracy and compliance.

Qualifications

• Bilingual in Korean and English is required.
• Strong communication skills with supervisors and other personnel are essential.
• Understanding production process lines is necessary.

Responsibilities

• Develop and implement production processes related to document control.
• Collect and register all technical documents in the system.
• Review and update documents for legal compliance and quality control.

Skills

Bilingual (Korean and English)

Strong communication skills

Understanding of production process lines

Ability to generate product-related documents

Education

BA or BS degree or equivalent

Tools

Document control systems

Job description

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
• 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