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QA Documentation Specialist

Edison-New Brunswick Metro Area, New Jersey

Post Date: 06/16/2017 Job ID: JN -062017-19299
Documentation Specialist - Pharmaceutical Facilities
Responsible for the authoring, modification, approval, and organization of technical documents including but not limited to: Standard Operating Procedures (SOP), Work Practices (WP), Reference Documents (REF), Forms (FORM), Preventive Maintenance (PM) and Standards (STD).

The Documentation Specialist performs and supports the coordination of all the Corporate Services documents to ensure effective and efficient documentation of data and process. This position is also responsible for the department s hard copy documentation organizing and control.

Responsibilities will include, but are not limited to, the following:

1. Support Corporate Services operations, including individual projects and assignments, as needed.
2. Maintaining original hard copy and electronic filing of technical documents and relevant indexes; ensuring files are properly prepared and accessible on line and maintained accordingly within archives.
3. Preparation and distribution of documents for signatures; as well as organizing, tracking status and timelines.
4. Manage calendar of periodic reviews (send and track notifications).
5. Provide controlled versions of documents, as requested.
6. Preparation of primary and supporting documents for submission for any type of review.
7. Other duties related to the above in support as Document Specialist for support to Corporate Services.
8. Demonstrates and promotes Celgene Values and behaviors.

ESSENTIAL FUNCTIONS:
Initiation, completion, and filing of required documentation as applicable.
Preparation of SOPs and Forms as needed.
Modification of technical documents as needed.

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