Quality Engineer

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner, we provide a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, playing a vital role in the global pharmaceutical industry. Our work helps develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project, including building a new state-of-the-art facility adjacent to our current facility.

About the role

The Quality Engineer is responsible for supporting incoming new client projects from the Quality perspective at August Bioservices. Successful candidates will be a team player with exceptional technical and communication skills, a strong background in Quality, and a high ability to collaborate with various levels of the organization.

Responsibilities

• Represent the Quality function in internal and external meetings related to new client projects, determining deliverables and timelines, and communicating upcoming activities with all of the Quality Organization (Quality Assurance, Quality Control, and Validation).
• Support technology transfer of product and processes from clients into August Bioservices manufacturing and laboratories from the Quality perspective. Projects may span R&D, Formulation Development, Clinical, and Commercial Manufacturing.
• Work cross-functionally with various internal departments to effectively transfer and maintain processes in the facility.
• Proactively identify CMC critical path items, risks, and impediments to successful transfer, and drive the identification and development of solutions to mitigate these risks.
• Provide support on projects to streamline new product introduction, including feedback in Change Review Board for change controls to introduce new products.
• Develop and implement phase-appropriate strategies for efficient transfers and identification of Quality deliverables.
• Work with Product Quality Assurance and Manufacturing to support generation of appropriate batch documentation.
• Communicate project status, upcoming deliverables, and timeliness to the Quality Organization.
• Collaborate with Manufacturing, Engineering, Supply Chain, and Commercial Operations to drive technical transfer of client products into August Bioservices for manufacture and laboratory testing.
• Act as a client-facing representative, working collaboratively with clients and internal cross-functional stakeholders to move projects forward.
• Provide support during internal audits and regulatory inspections.
• Adhere to company policies and applicable regulatory agencies requirements (ICH, FDA, etc.) to ensure compliance.
• Communicate clearly with cross-functional teams.

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 PIC/S 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.
• FDA Guidance on Aseptic Processing and Part 11 compliance knowledge preferred.
• Ability to work in a fast-paced environment, efficiently prioritize work, and quickly communicate project information to the team.

Physical Requirements

• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.

About Us

At August Bioservices, our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard and an everyday measuring stick of our advancement. We aspire to unlock the potential in every person, every process, and every molecule – from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred, and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.