Document Controller New Brunswick, NJ, United StatesAbout the JobThe 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 documents, such as drawings and blueprints, in the Company's 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 & VisionPTO401(k) Incentives Relocation Assistance
