Quality Assurance Auditor Jobs

Title: Quality Assurance Auditor

Job Purpose:

The Quality Auditor is responsible for managing and performing Marken internal audits and external supplier audits. The Quality Auditor will prepare audit reports, address CAPAs and track vendor responses for all audits to ensure Marken GxP compliance. The Auditor will be responsible addressing Change Controls regarding or submitted from Marken vendors. This position will be responsible for operating cross-functionally, working with all Marken services lines.
Main Duties and Responsibilities:

• Work with regional 3rd party vendors and suppliers to develop quality improvements.
• Manage Change Controls regarding or submitted from Marken vendors.
• Effectively interact with Depot Quality Managers, Operations/Depot Managers, and stakeholders to maintain quality.
• Perform internal audits at various Marken locations in the NORAM region and manage audit responses.
• Host client audits at various Marken locations in the NORAM region.
• Ensure timely and efficient management of records pertaining to the Quality Assurance.
• Prepare and maintain an audit schedule, interacting with Global/Locations/Regions.
• Prepare audit reports and follow up to track all actions to closure.
• Perform audits/assessments of Marken vendors to assess their compliance with GxP and with Marken’s business requirements.
• Prepare audits and observation metrics.
• Travel as reasonably requested (approximately 50%) for the performance of duties.
• Work closely with Global Quality Assurance and other Regional Quality Auditors.
• Ensure compliance with national and international standards and legislation.
• Support Marken’s culture of continuous improvement by introducing new quality advances.

Requirements:

• Excellent written and oral communication skills
• Proficient use of Microsoft Office
• Bachelor's degree in a related field or the equivalent combination of relevant education and professional experience
• Good interpersonal skills
• Organized, methodical and efficient approach to work
• Comprehensive knowledge of GxP guidelines - Good Manufacturing Practices and/or Good Distribution Practices – as applied within the pharmaceutical industry
• 5+ years of experience working in a Quality Assurance role within a GxP regulated position (Senior or Lead Auditor experience required)

Marken is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, and supports cell and gene therapy logistics services from clinical to commercial, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production.
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