
Senior Labeling
2 weeks ago
Job Summary:
We are seeking a skilled Labeling & Packaging Document Control Specialist to manage labeling databases, track issues, and maintain QSR (Quality Systems Records) and related materials for the creation/revision and control of customer labeling. The ideal candidate will have experience working with ISO, cGMP, and FDA guidelines.
Key Responsibilities:- Manage documents to support Labeling Development in compliance with established formats and templates.
- Complete Engineering Change Requests for Global Labeling & Packaging.
- Initiate the collaborative review process and assist document users with inquiries and research.
- Track documentation through the entire development process while adhering to strict timelines and maintaining revision control.
The successful candidate will be responsible for expediting change request consideration and approval processes, coordinating reviews by stakeholders, managing stakeholders and approvers for timely response on change management requests, and maintaining comprehensive change management files and documentation.
Required Skills and Qualifications:- Strong knowledge of Microsoft Office's suite of products.
- Minimum 3 years of hands-on experience in a medical device document controller role.
- Excellent communication skills, both written and verbal.
- Ability to work independently and in a team environment, with strong follow-up, organization, and prioritization skills.
This is an exciting opportunity to join our team as a Labeling & Packaging Document Control Specialist. If you have the skills and experience we're looking for, please don't hesitate to apply.
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