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Kelsterbach, Germany

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653f3f8d6c75

1

11.05.2025

25.06.2025

Title: Quality Assurance Associate (m/f/d)

To mainly provide support to the CAPA System, Trainings, Vendor qualification process, and records review.

• Maintain the culture of the importance of an integrated quality system within the company.
• Train vendors and MKN employees on quality topics.
• Support the CAPA System.
• Investigate deviations and develop effective action plans.
• Complete CAPAs and conduct Effectiveness Checks.
• Support the Vendor Qualification process.
• Assist with the Document Control process.
• Maintain quality policies and procedures per company requirements.
• Evaluate and approve documents according to standards and regulations.
• Create and review instructions / SOPs.
• Collaborate with logistics to ensure operational effectiveness and compliance.
• Support quality audits and client qualification processes.

• Experience with Quality Management Systems and attention to detail.
• Knowledge of GxP.
• Good interpersonal skills, conflict mediation, and a sense of urgency.
• Ability to analyze details thoroughly.
• Ability to work remotely (home office).
• At least 1 year of relevant experience, preferably in pharmaceutical/biotech industry, including quality and logistics.
• Degree or recent graduation in Pharmacy or a related field.

Marken is a subsidiary of UPS, providing GMP-compliant depot and logistics services for clinical and commercial products, supporting cell and gene therapy logistics, and more.

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