Healthcare QA Specialist

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Job Description:

Company overview

Marken, UPS Healthcare Precision Logistics (formerly Marken, MNX & Polar Speed), the clinical and advanced therapy subsidiary of UPS Healthcare, unites expertise across healthcare and complex secure logistics to drive the success of our clients through innovation.

Job Description:

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 

Qualifications: 

• 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 

• Feasibility for home office 

• 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 

Employee Type:  

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