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Analyst I, QC Raw Materials

Genezen

📍 Lexington, MA

Posted 2 months ago

Quick Info

Experience Level

Entry Level

Minimum Degree

Bachelor

Department

Quality Assurance Control
0

Job Type

Full Time

Specialty Skills

cGMPUSPEPJPQMSDeviationsCAPAOOSAROOTSOPsMaterial SpecificationMethod ValidationMethod Verification

About the Role

The Quality Control (QC) Raw Materials Analyst is responsible for ensuring the quality of raw materials are suitable for the intended use by the Manufacturing Department. These activities are performed in accordance with cGMP, USP, EP, and JP guidelines as well as company policies and procedures. The QC Raw Materials Analyst I will support the day-to-day operations which include sampling, internal and external testing, controlling and releasing raw materials, as well as support QMS (Deviations, CAPA, Lab Investigations (OOS, AR, OOT), Documentation (SOPs/Forms/Material Specification), laboratory operational processes and Training. Supports method validation/verification activities for onboarding new raw materials, as well as internal/external audits.

About Genezen

Therapies for autoimmune and inflammatory diseases

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