Sr./Specialist, Quality Assurance Operations

Job Description

AmplifyBio, LLC, a leading contract research organization, is looking for a talented Senior/Specialist, Quality Assurance Operations to join their growing team. The ideal candidate will have experience in GMP environments and a strong understanding of biologics processes, particularly in cell & gene therapy, aseptic environments, reagent control, and contamination control.

Responsibilities

• Review and approve GMP documentation, including SOPs, batch records, deviations, and investigations.
• Provide training on Quality topics and foster a quality culture.
• Manage lot/product disposition activities and participate in quality audits.
• Support Tech Transfer activities and finished product shipments to clinical sites.

Requirements

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

Benefits

• Health, Dental, and Vision insurance from day one.
• Competitive compensation package and flexible PTO policy.
• Generous paid parental leave and wellness programs.
• 401(k) match, tuition reimbursement, and EAP/work-life support.
• Opportunity to work in a collaborative environment and contribute to groundbreaking work.