What are the responsibilities and job description for the Quality Assurance Associate position at Marken?
Description
Title :
Quality Assurance Associate
Job Purpose :
To mainly provide support to the CAPA System, Trainings and Vendor qualification process and records review.
Main Duties and Responsibilities :
- Maintain the culture of the importance of an integrated quality system within the company
- Trainer of topics related to Quality for vendors and MKN employees
- Support in THE CAPA System
- Completion of investigations via effective investigation of deviations and the development of effective action plans
- Completion of CAPAs and Effectiveness Checks
- Preparing deviation reports
- Support the Vendors Qualification process
- Assist with the "Document Control" process
- Maintain quality policies and procedures in accordance with company requirements
- Evaluate and approve documents according to the organization's standards and local regulations
- Instructions / SOP creation and review
- Collaborate with the logistics team to monitor the entire process, ensuring the effectiveness and compliance of all operations
- Support quality audits and client's Marken qualification processes
Requirements :
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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