Quality Assurance Associate jobs in United States
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Gandiv Insights LLC · 2 days ago

Quality Assurance Associate

Gandiv Insights LLC is focused on supporting GMP manufacturing and quality systems. They are seeking a Quality Assurance Associate to ensure compliance with FDA regulations and cGMP standards while partnering with various departments to maintain product quality and inspection readiness.

Information Technology & Services

Responsibilities

Review and approve batch records and GMP documentation
Ensure cGMP and FDA compliance
Perform in-process and final inspections
Support deviations, root cause analysis, and CAPAs

Qualification

CGMP knowledgeBatch record reviewQA experienceDeviationsCAPAQMS toolsBachelor’s degreeAudit supportALCOA+ knowledgeBiologics experienceSterile manufacturing experience

Required

Bachelor's degree or equivalent experience
2–5 years QA experience in pharma/biotech
Strong cGMP knowledge and batch record review experience
Experience with deviations, CAPA, and change control

Preferred

Biologics or sterile manufacturing experience
QMS tools (TrackWise, Veeva, LIMS)
Audit support and ALCOA+ knowledge

Company

Gandiv Insights LLC

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Gandiv Insights is a leading professional services and staffing firm specializing in top-tier personnel and technical solutions across engineering, IT, non-IT, and healthcare sectors.

Funding

Current Stage
Growth Stage
Company data provided by crunchbase