Sr./Specialist, Quality Assurance Operations

Job Description

AmplifyBio is seeking a highly experienced Senior/Specialist in Quality Assurance Operations to join our dynamic team. The ideal candidate will have a strong background in GMP environments, biologics processes, and regulatory compliance.

Responsibilities

• Review and approve all GMP documentation including SOPs, batch records, deviations, investigations, and validation/qualification protocols.
• Manage lot/product disposition activities and provide training on quality topics to promote a culture of excellence.
• Conduct compliant investigations, support tech transfer activities, and participate in quality audits.
• Collaborate with cross-functional teams and present data during meetings as necessary.

Requirements

• Bachelor’s degree in a relevant scientific discipline.
• 2 - 4+ years of Quality and GxP biotechnology/pharmaceutical experience.
• Strong knowledge of GMP regulations, experience with eQMS (e.g., Veeva), and familiarity with early-phase clinical program guidelines.
• Excellent interpersonal, leadership, and communication skills with attention to detail.
• Experience in cell & gene therapy considered a plus.

Why Join Us

• Competitive compensation package and health benefits.
• Flexible PTO policy and generous paid parental leave.
• Wellness programs, 401(k) match, and tuition reimbursement.
• Inclusive and diverse work environment that values every voice.

Be part of a team that is changing the world – apply now and make a difference!