Quality Assurance Associate
3 weeks ago
We are seeking a highly skilled Quality Assurance Associate to join our team at Marken, a leading global clinical supply chain solutions provider.
About the RoleThis is a challenging and rewarding opportunity to work in a fast-paced environment where you will be responsible for providing support to our CAPA System, Trainings, and Vendor qualification process, as well as records review.
Main Responsibilities- Maintain an integrated quality system culture within the company
- Train vendors and employees on quality-related topics
- Support the CAPA System and complete investigations
- Develop effective action plans and prepare deviation reports
- Assist with vendor qualification and document control processes
- Evaluate and approve documents according to company standards and local regulations
- Create and review instructions/SOPs
- Collaborate with logistics teams to ensure operational effectiveness and compliance
- Bachelor's degree in life sciences or a related field
- Minimum 3 years of relevant experience in Quality and Logistics, including Pharmaceutical/Biotechnology industry experience
- Previous experience in Quality Management Systems with attention to detail
- Knowledge of GxP
- Excellent interpersonal skills, conflict mediation, and sense of urgency
- Ability to analyze and work in detail
Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide. We provide cell and gene therapy logistics services from clinical to commercial, while maintaining a leading position in Direct-to-Patient and Home Healthcare services, biological sample shipments, and biological kit production.
Salary Range$65,000 - $85,000 per annum, depending on experience
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