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CMC/Quality Aspect Associate IIIMedimmune - Gaithersburg, MDEssential Job Functions:* Serves as Chemistry, Manufacturing & Control (CMC) representative on development, manufacturing, validation, and quality project teams assigned and as need arises* Performs technical writing functions in support of FDA submissions including initial review and preparation of documentation, compilation of documents, coordination of review and approval with Regulatory Affairs* Collects reviews and assembles information such as scientific, manufacturing and validation areas from in-house or contract manufacturing organization* Responsible for the preparation, control and maintenance of regulatory support documents (e.g. Drug Manufacturing File, Site Master File)* Proactively supports senior Quality Assurance and Regulatory Affairs staff in the development and implementation...originally from HH - More Tools...
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Medimmune
Line of Business: Mfg Develops & Researches And Markets Products For Infectious Disease Immune Regulation And Cancer
Key Numbers:
| Company Type | Public (MEDI:NMS) |
|---|---|
| Company Revenue | $500M+ |
| Company Size | 1000 - 5000 employees |
Job Location:
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