RayzeBio · 6 hours ago

Auditor, Vendor Quality

United States

Full-time

Remote

Mid, Senior Level

$80K/yr - $108K/yr

5+ years exp

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BiotechnologyHealth Care

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Responsibilities

Author and maintain external audit schedule

Schedule and coordinate external vendor audits

Review, communicate and track audit findings

Create, review, approve, and track corrective actions related to external audits.

Support the review, discussion and approval of Quality Agreements for external vendors

Participate in vendor reviews, provide input for the topics that relate to vendor performance and audits outcome.

Support site activities that relate to the vendor change notification program and vendor complaint management program.

Help establish and maintain the Vendor Management program

50% of travel or as required

Direct communication to Vendor, schedule and conduct on site, virtual or paper audit/assessment

Report writing and Vendor performance metrics

Ensure suppliers are qualified and conduct audits at defined frequencies as part of the supplier monitoring process.

Supporting an early phase to commercial facility

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Vendor QualificationVendor AuditsGMP Pharmaceutical ManufacturingFDA RegulationsEU RegulationsElectronic Quality Management SystemsAnalytical Problem SolvingWriting ProceduresWriting ReportsWriting MetricsWriting DashboardsMicrobiology KnowledgeRadiopharmaceuticals KnowledgeASQ Auditing Certificate