CMC & Tech Transfer Quality Engineer

Augustbioservices; Nashville (TN); On-site; USD 90,000 - 140,000; Full time

Job summary

August Bioservices in Nashville, TN seeks a Quality Assurance Engineer to support incoming client projects from the Quality perspective, ensuring compliant and timely delivery across GMP processes. The role will drive documentation, change controls, and collaboration with cross-functional teams to enable successful product transfers.

The candidate should have a Bachelor’s or Master’s degree and 5+ years of QA experience in biotech/pharma manufacturing, with strong GMP knowledge and

Qualifications

• Bachelor’s or Master’s Degree and 5+ years of QA experience in biotech/pharma manufacturing.
• Strong GMP knowledge incl. 21 CFR210, 211, 820, EU GMP guidelines, Part 11 awareness.
• Experience with CMC and technology transfer activities.
• Ability to work in a fast-paced environment and communicate across teams.

Responsibilities

• Represent Quality in internal and external meetings for new client projects; determine deliverables and timelines.
• Support technology transfer of products and processes from clients into August Bioservices.
• Collaborate cross-functionally with Manufacturing, Engineering, Supply Chain and Commercial Operations.
• Identify CMC risks and impediments; develop solutions to mitigate them.
• Provide support during internal audits and regulatory inspections; ensure regulatory compliance.

Skills

Quality Assurance

CMC knowledge

Technology transfer

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s or Master’s Degree

Job description

August Bioservices in Nashville, TN seeks a Quality Assurance Engineer to support incoming client projects from the Quality perspective, ensuring compliant and timely delivery across GMP processes. The role will drive documentation, change controls, and collaboration with cross-functional teams to enable successful product transfers.

The candidate should have a Bachelor’s or Master’s degree and 5+ years of QA experience in biotech/pharma manufacturing, with strong GMP knowledge and