The Quality Assurance Specialist – Auditor (QA) manages and performs vendor qualifications and supports client and regulatory audits. The role includes vendor onboarding, preparing audit reports, addressing corrective and preventive actions (CAPAs), and tracking audit responses to ensure GxP compliance. This temporary 12-month assignment supports the MNX integration project, focusing on onboarding MNX vendors in accordance with Marken, GDP, and other applicable requirements. The position requires cross-functional collaboration across Marken PL service lines. The QA Associate maintains compliance with Marken’s PL Global Quality Management System and local regulatory requirements, supports quality initiatives and continuous improvement, and manages vendor qualification activities. These include performing audits, updating Quality Technical Agreements, assessing vendor risk, monitoring documentation and regional vendor-management activities, and managing vendor-related changes and deviations. The role also supports records management and quality tasks as needed, with travel as reasonably requested. The posting states that employment is intended to end automatically after the 12-month term unless both parties agree in writing to an extension.
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