Quality Assurance Associate - Marken : Job Details

DescriptionTitle: Quality Assurance AssociateJob 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 companyTrainer of topics related to Quality for vendors and MKN employeesSupport in THE CAPA SystemCompletion of investigations via effective investigation of deviations and the development of effective action plansCompletion of CAPAs and Effectiveness ChecksPreparing deviation reportsSupport the Vendors Qualification processAssist with the Document Control processMaintain quality policies and procedures in accordance with company requirementsEvaluate and approve documents according to the organization's standards and local regulationsInstructions / SOP creation and reviewCollaborate with the logistics team to monitor the entire process, ensuring the effectiveness and compliance of all operationsSupport quality audits and client's Marken qualification processesRequirements:Bachelors degree in life sciences or related fieldMinimum 3 years of relevant experience, including Quality and Logistics experience in Pharmaceutical/ biotechnology industry Previous experience in Quality Management Systems with an eye for detailsKnowledge of GxPGood interpersonal skills, conflict mediation, sense of urgency to complete assignments on timeAbility to analyze and work in detailMarken 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.