at Amneal Pharmceutical of New York LLC
Posted in Management 30+ days ago.
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Location: Brookhaven, New York
- This role prepares written documentation of Manufacturing Technical Services activities.
- Completes technical writing, including creation of Master Batch Records, and reviews of Master Batch Records.
- Formats documents for regulatory purposes.
- Prepares technical memos, deviations, initiation of change controls.
- Reviews documents for quality and consistency.
- Works in collaboration with team leaders to create the highest quality documents.
- Prepares technical documents, such as study protocols, reports, compiling data in addition to writing batch records.
- Coordinates document review and approval processes and archiving.
- Bachelors Degree (BA/BS) Related field - Required
- Preferably in creating documents of Oral Solids (Pharmaceutical)
- Experience in cGMP or GLP regulated industry
- Expert level skill with Microsoft Word, Excel, Powerpoint Adobe Acrobat; excellent oral and technical writing skills. - Advanced
- Ability to handle multiple tasks independently and manage with competing priorities and attention to detail. - Advanced