Job Scope:
Seeking a contract Document Coordinator to lead document coordination of all documents required for new building expansion for the purpose of packaging and warehousing pharmaceuticals. This role will work closely with site Project Management, Quality, Validation, Operation and project personnel to understand what documents are needed for the project. And work directly with technical writers who will create SOPs protocols, reports, and other deliverables specific to the new building project, maintenance and operations.
Duties:
- As a Document Coordinator, you’ll be a part of the project management team and be required to do the following items.
- Overseeing the integrity of information and curating efficient data retrieval procedures.
- Oversee the storage, categorization, and retrieval of both electronic and physical documents to ensure easy access and traceability.
- Own the document tracking worksheet, including SOPs, Work Instruction, Engineering Specifications, Validation Documents and more.
- Coordinate with other area project owners the creation, review, and approval of all documents in the project.
- Review, verify, and validate documents for accuracy and completeness, making corrections where necessary.
- Ensure all documentation meets internal standards and regulatory compliance requirements.
- Liaise with various departments to integrate data and ensure consistency in documentation practices.
- Recommend process improvements to enhance efficiency, security, and accessibility in document management.
Qualifications:
- Education: Technical degree preferred
- A Document Coordinator with packaging and warehouse storage knowledge is preferred.
- A Document Coordinator with overall operation experience is preferred as this is a new facility expansion.
Experience:
- Minimum five years GxP experience
- Previous key role in coordinating document in a new facility expansion.
- Quality, Operation or facility pharmaceutical experience
- These additional experiences are a plus:
- Veeva Document Management Experience.
- Kneat Paperless Validation Experience.
OH (Onsite): Documentation Coordinator (236008)
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