Quality Engineer - CMC & Tech Transfer

August Bioservices; Nashville (TN); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

August Bioservices is seeking a Quality Engineer to lead QA efforts for new client projects, ensuring timely deliverables and seamless technology transfer into manufacturing and laboratories. The role requires a Bachelor’s or Master’s degree and 5+ years in QA within biotech/pharma, with a proven CMC transfer track record and strong GMP/regulatory knowledge.

You will collaborate across Manufacturing, Engineering, Supply Chain and Commercial Operations to drive compliant, efficient product

Formación

• Bachelor’s or Master’s Degree and 5+ years of experience in Quality Assurance within a biotechnology, biologics, or pharmaceutical manufacturing facility.
• Must have 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.
• Work occurs in a fast-paced environment. Individual must be able to efficiently prioritize own work and quickly communicate project information to the team.

Responsabilidades

• Represents the Quality function in meetings related to new client projects, determining deliverables and timelines.
• Support technology transfer of product and processes from clients into August Bioservices from the Quality perspective.
• Work cross-functionally with Manufacturing, Engineering, Supply Chain and Commercial Operations to transfer and maintain processes.
• Identify CMC critical path items, risks, and drive solutions to mitigate them.
• Provide support on projects to streamline new product introduction and change controls to introduce new products.
• Develop and implement phase appropriate strategies for efficient transfers and QA deliverables.
• Work with Product Quality Assurance and Manufacturing to generate batch documentation.
• Communicate project status, upcoming deliverables and timeliness to the Quality Organization.
• This position will be client facing and requires collaboration with clients and internal stakeholders to move projects forward.
• Provide support during internal audits and regulatory inspections.
• Adhere to company policies and applicable regulatory requirements (ICH, FDA) to ensure compliance.
• Communicate clearly with cross-functional teams.

Conocimientos

Quality Assurance

CMC

Technology transfer

GMP knowledge

Regulatory compliance

Educación

Bachelor’s or Master’s Degree in a relevant field

Descripción del empleo

August Bioservices is seeking a Quality Engineer to lead QA efforts for new client projects, ensuring timely deliverables and seamless technology transfer into manufacturing and laboratories. The role requires a Bachelor’s or Master’s degree and 5+ years in QA within biotech/pharma, with a proven CMC transfer track record and strong GMP/regulatory knowledge.

You will collaborate across Manufacturing, Engineering, Supply Chain and Commercial Operations to drive compliant, efficient product