Quality Engineer
August BioservicesNashville, Tennessee, United States
Posted September 23, 2024
Full Time
About the Company
August Bioservices is a CDMO specializing in pharmaceutical development, focusing on sterile and complex formulations.
Job Description
The Quality Engineer is responsible for supporting incoming new client projects from the Quality perspective at August Bioservices. The role involves working with various internal departments to effectively transfer and maintain processes in the facility, and communicating project status and upcoming deliverables to the Quality Organization.
Requirements
- Bachelor's or Master's Degree and 5+ years of experience in Quality Assurance within a biotechnology, biologics, or pharmaceutical manufacturing facility
- Proven track record with CMC and technology transfer
- GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing and Part 11 compliance knowledge preferred