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Labeling Specialist
2 months ago
- Looking for an experienced Labeling Specialist II to create and revise labeling components for In Vitro Diagnostic (IVD) products and related documentation regulated by the FDA and ISO 13485.
- This position requires a person who is detail-oriented, can manage multiple priorities, and has strong organizational skills. The Labeling Specialist must be accustomed to working within established timelines and have a high attention to detail.
- Scope, redline and update labeling and documentation to support labeling changes.
- Prepares and routes documents through the eDMS system.
- Maintains open communication and customer support to various functional groups within the organization.
- High school diploma or Equivalent.
- At least 2+ years of experience processing labeling changes in a regulated environment and/or 2+years in packaging engineering.
- Advanced organizational skills and ability to manage multiple priorities with the ability to work in deadline-oriented environment.
- Understanding of Good Documentation Practices (GDP) and Document Controls.
- Understanding of BOMs (Bill of Materials) and Specification documents.
- Must be able to write clear, understandable documentation.
