Quality Consultant

Job Description

Contract SOP Writer – Pharma Distribution & Logistics | Warren, NJ (Hybrid)

I’m hiring a contract Quality Consultant for a global pharmaceutical company in Warren, NJ. They need US distribution procedures written and inspection-ready ahead of upcoming regulatory inspections.

Details

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• 6-month contract
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• Start ASAP
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• Hybrid: 3 days onsite in Warren, NJ
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What you’ll do

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• Write US-market SOPs from scratch and adapt existing global versions. Topics include 3PL oversight, product release and disposition, cold chain temperature excursions, recall, deviation/CAPA/change control, and state licensing verification.
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• Build process flow maps in Visio, Word, or Excel that link to each SOP
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• Route SOPs for Quality and Supply Chain approval
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• Maintain version control of hard and electronic copies so they are ready for inspection
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• Work with Logistics, Quality, IT, and Finance teams
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What you need

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• 7+ years in pharma quality or supply chain. Medical device experience is also considered.
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• Proven experience authoring SOPs yourself
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• Knowledge of pharma distribution and 3PL operations
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• Strong Word and Excel formatting skills
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• Veeva or other eDMS experience is a plus but not required
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