Quality Assurance Associate

3 weeks ago


Malvern, Pennsylvania, United States Marken Full time
Job Overview

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 Role

This 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
Requirements
  • 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
Why Choose Us?

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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