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Packaging Technical Writer
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Full-time
- This is an entry-level position viewed as a supporting resource to TS Packaging Engineer during generation of packaging records and documents required for FDA filings.
- Author/assist with preparation of new the packaging batch records and associated change controls to support the Private Label products launches and commercialization.
- Assist TS Packaging Engineer with preparation of CMC documents to support submissions to agency (eCTD sections).
- Provide assistance to TS Packaging Engineer in the safe and compliant packaging of pharmaceutical products as related but not limited to the following activities/projects: packaging Technology Transfer, packaging process development for new products, commercial process optimization, etc.
- Preferred knowledge of and experience in pharmaceutical packaging systems (bottle, cup, unit-dose fill/seal, induction seal, etc.)
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