Sr./Specialist, Quality Assurance Operations

Job Description

AmplifyBio, LLC is seeking a talented Senior/Specialist, Quality Assurance Operations to join our growing team. As part of our innovative ecosystem focused on advancing pharmaceutical products, you will play a crucial role in ensuring quality and compliance in GMP environments.

What You'll Do Here:

• Review and approve GMP documentation including SOPs, batch records, deviations, investigations, and more.
• Provide training and guidance on Quality topics to foster a culture of excellence.
• Manage lot/product disposition activities and support Tech Transfer for new projects.
• Participate in quality audits, provide analytical support, and facilitate finished product shipments to clinical sites.

We Would Love to Hear from You If:

• Have a bachelor’s degree or higher in a relevant scientific discipline.
• 2-4+ years of experience in Quality and GxP biotechnology or pharmaceutical environment.
• Extensive knowledge of cGMP quality systems and experience with eQMS.
• Strong teamwork, leadership, and communication skills.
• Experience in cell & gene therapy is a plus.

Why You Will Love Working Here:

Joining AmplifyBio means being part of a diverse and inclusive community committed to groundbreaking work. We provide competitive compensation, flexible PTO, paid parental leave, wellness programs, and more. Your contribution will make a difference in changing the world!

Apply now and be part of our exciting journey!