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