Senior Quality Assurance Specialist

4 weeks ago


Étreux, Hauts-de-France, United States Master Compliance Full time
Job Title: Quality Control Lead

At Master Compliance, we are seeking a highly skilled Quality Control Lead to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our operations.

Key Responsibilities:
  • Review and approve protocols, test reports, and certificates of analysis/compliance to ensure compliance with regulatory requirements.
  • Compile and review analytical and quality control data to identify trends and areas for improvement.
  • Collaborate with the analytical development/quality control team to coordinate sample pulls, set downs, and tracking of critical reagents.
  • Maintain accurate and thorough records and documentation.
  • Support method development, transfer, and qualification/validation activities for the release of bacterial plasmids, viral vectors, critical reagents, and reference materials.
  • Conduct laboratory work as required by review priorities.
  • Trend data for qualified materials, released products, and stability programs.
  • Assist in drafting and reviewing quality documentation such as SOPs, OOS/OOT reports, CAPAs, and Change Controls.
  • Serve as a liaison with contract manufacturing organizations (CMOs) to coordinate method development, transfer, and stability testing at various CMO/CRO sites.
  • Author and review test methods, development reports, study protocols, and validation reports.
  • Perform other related duties as required.
Requirements:
  • Bachelor's or Master's degree in molecular biology, cell biology, or virology with 5-8 years of relevant experience.
  • Experience in a cGMP environment is preferred.


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