Quality Assurance Associate

hace 7 días

Tlahuac, México Marken A tiempo completo

**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**:
Previous experience in Quality Management Systems with an eye for details
Knowledge of GxP
Good interpersonal skills, conflict mediation, sense of urgency to complete assignments on time
Ability to analyze and work in detail
1+ years of relevant experience, including Quality and Logistics experience in Pharmaceutical/ biotechnology industry experience a plus
Finishing or recently graduated of a bachelor related to Pharmacy or similar

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.

Moving Our World Forward by Delivering What Matters.

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