Sr./Specialist, Quality Assurance Operations

Job Description

Are you passionate about significantly improving the future of medicine? Join AmplifyBio, LLC as a Senior/Specialist, Quality Assurance Operations. AmplifyBio is a leading contract research organization offering comprehensive services in drug discovery, preclinical studies, and advanced therapy manufacturing.

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 and quality audits.
• Participate in cross-functional meetings and present data when needed.

Requirements

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

Why Choose Us?

• Competitive compensation package.
• Flexible PTO policy and generous paid parental leave.
• Wellness programs and 401(k) match.
• Tuition reimbursement and EAP/work-life support.
• An inclusive and empowering work environment with growth opportunities.

Join us to be part of groundbreaking work and make a difference in the world!