Senior Quality Assurance Operations Specialist

6 days ago


New Albany, Ohio, United States AmplifyBio Full time
About the Role

We are seeking a highly skilled Quality Assurance Operations Specialist to join our team at AmplifyBio. As a Quality Assurance Operations Specialist, you will play a critical role in ensuring the quality and compliance of our cell and gene therapy manufacturing operations.

Key Responsibilities
  • Document Review and Approval: Review and approve GMP documentation, including SOPs, batch records, deviations, and investigations, to ensure compliance with regulatory requirements.
  • Quality Metrics and Analysis: Develop and maintain quality metrics and analysis to track and trend lot and product disposition activities.
  • Quality Culture and Mindset: Foster a quality culture and quality mindset within the organization by providing guidance and training on Good Documentation Practices.
  • Investigations and Root Cause Analysis: Conduct investigations and root cause analysis to identify and resolve quality issues.
  • Collaboration and Communication: Collaborate with cross-functional teams, including Program Management, Manufacturing, Quality Control, and Supply Chain, to ensure quality and compliance.
Requirements
  • Education: Bachelor's degree or higher in a relevant scientific discipline, such as Bioinformatics, Biology, Biochemistry, or Chemistry.
  • Experience: Minimum of 2-4-8+ years of experience in Quality and GxP biotechnology or pharmaceutical environment with supervisory responsibilities.
  • Skills: Strong understanding of GMP regulation and guidelines, including 21 CFR Part 210 and 211. Experience with eQMS systems, such as Veeva, and strong interpersonal and communication skills.
About AmplifyBio

AmplifyBio is a leading contract research organization providing comprehensive services for cell and gene therapy manufacturing. We are committed to growing and empowering an inclusive community within our company and industry.



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