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Packaging Documentation Specialist Position
3 weeks ago
Packaging documentation specialists play a crucial role in maintaining quality systems records and ensuring compliance with ISO, cGMP, and FDA guidelines.
Key Responsibilities:- Manage documents according to established formats and templates, adhering to strict timelines and revision control.
- Process engineering change requests for global labeling and packaging.
- Coordinate review processes and assist users with inquiries and research.
- Track documentation through development while maintaining change lists and managing reviewers.
- Facilitate change request consideration and approval processes, including coordinating reviews by stakeholders.
- Proficiency in Microsoft Office and 3+ years' experience in medical device document controller roles.
- Strong self-motivation, ability to work independently and in teams, and excellent communication skills.
- Capacity to learn new concepts quickly and manage multiple projects simultaneously.
This position demands a high level of quality, clarity, and consistency in all documents and effective working relationships with coworkers, managers, and clients.
