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Intelliswift

Quality Compliance Associate

Intelliswift, Novato, California, United States, 94949


Support Quality Compliance processes including inspection readiness, self-inspection program, data integrity initiatives, and regulatory certification activitiesSupport or lead continuous improvement in quality systems (procedures and systems) to improve organizational effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH).Adhere and follow cGMPs guidelines and procedures. Escalate non-compliance concerns to management.Interface with other *** departments (Manufacturing, Quality Control, Technical Development, Quality Assurance, etc.) and contractors as necessaryInterpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directivesOther duties as assigned

Prior experience in Manufacturing, Quality Control, and Quality Management System (QMS) processesExcellent written, verbal, analytical, and interpersonal skills