- Amplifybio, LLC
- New Albany, OH
- 03-01-2024
Job Description
AmplifyBio, LLC, a leading contract research organization specializing in discovery, preclinical studies, and manufacturing services for advanced therapies, is seeking a Senior/Specialist, Quality Assurance Operations to join their dynamic team. The ideal candidate will have a strong background in GMP environments, biologics processes, and quality assurance operations.
Responsibilities
- Review and approve GMP documentation, including SOPs, batch records, deviations, and investigations.
- Manage lot/product disposition activities and document training on quality topics.
- Participate in quality audits and support tech transfer activities for new projects.
- Collaborate with cross-functional teams and present data during departmental meetings.
Requirements
- Bachelor's degree in a relevant scientific discipline.
- 2-4+ years of experience in Quality and GxP biotechnology/pharmaceutical environments.
- Knowledge of GMP regulations and experience with cGMP quality systems.
- Experience with eQMS systems like Veeva is preferred.
Why Join Us
Join a diverse and inclusive community committed to innovation and empowerment. Enjoy competitive compensation, comprehensive benefits, flexible PTO, paid parental leave, and ongoing wellness programs.
Be part of groundbreaking work shaping the future of advanced therapies in a collaborative and supportive work environment.
Apply now and be a part of changing the world with AmplifyBio!