Sr./Specialist, Quality Assurance Operations

Job Description

AmplifyBio, LLC is looking for a passionate and experienced Senior/Specialist in Quality Assurance Operations to join our dynamic team. As a key member of our quality assurance department, you will play a critical role in ensuring compliance, managing lot disposition activities, providing quality training, and supporting various operational functions.

Responsibilities

• Review and approve GMP documentation.
• Manage lot/product disposition activities.
• Provide training on Quality topics and foster a quality culture.
• Support Tech Transfer activities for new projects.
• Participate in quality audits and regulatory compliance.

Requirements

• Bachelor’s degree or higher in a relevant scientific discipline.
• 2-4+ years of experience in Quality and GxP biotechnology or pharmaceutical environment.
• Extensive cGMP quality system knowledge.
• Experience with eQMS, such as Veeva.
• Strong interpersonal, leadership, and communication skills.

Benefits

• Health, Dental, and Vision insurance.
• Generous paid parental leave and flexible PTO policy.
• 401(k) match and Tuition Reimbursement.
• Wellness and Self-Care Programs.
• A collaborative and inclusive work environment.
• Opportunity to be part of groundbreaking work.