About The Position

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.

Requirements

  • Must be a U.S. Citizen or National of the U.S., an alien lawfully admitted for permanent residence, or an alien authorized to work in the U.S. for this employer.
  • Adhere to Good Manufacturing, Distribution, and Clinical Practices.
  • Travel as reasonably requested for the performance of duties.

Nice To Haves

  • ASQ or ISO certification is preferred.

Responsibilities

  • Maintain compliance with Marken’s PL Global Quality Management System and local regulatory requirements.
  • Collaborate with Marken PL departments and stakeholders to support quality initiatives and continuous improvement.
  • Manage the vendor qualification program, including performing audits and updating Quality Technical Agreements (QTAs).
  • Ensure vendors comply with GxP, regional and local regulations, and Marken PL business requirements.
  • Prepare audit reports and track corrective actions (CAPAs) through closure.
  • Conduct vendor risk assessments based on audit findings and business impact, and escalate high-risk issues as needed.
  • Ensure vendor documentation meets data integrity standards and other applicable industry standards.
  • Monitor regional vendor management activities and ensure alignment with the global vendor management program.
  • Work with vendors to manage changes and implement quality improvements related to their services.
  • Manage and approve change controls and deviations submitted by or related to Marken vendors and suppliers.
  • Ensure compliance with national and international standards and legislation, and adhere to Good Manufacturing, Distribution, and Clinical Practices.
  • Interact with Global and Regional Quality Assurance personnel, Quality Managers, Branch, Operations, and Depot Managers, and other stakeholders to maintain quality.
  • Support continuous improvement by introducing new quality advances.
  • Manage Quality Assurance records in a timely and efficient manner.
  • Support daily tasks and issues as needed, travel as reasonably requested, adhere to company policies, and undertake other reasonable duties requested by the Line Manager.
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