Document Controller
ISEE Careers
Document Controller
New Brunswick, NJ, United States
About the Job
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 documents, 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
Vacancy posted 9 days ago
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