Augustbioservices18d ago

Associate Quality Engineer

United States·NashvilleFull-Timemid

EngineeringQuality Engineer

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Overview

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,

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EngineeringQuality 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 that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to 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. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!

The Associate Quality Engineer supports quality activities related to the introduction of new products and projects into the quality system. This role works closely with Quality Engineers to assist with documentation development, project coordination, and quality system execution during new product onboarding.

In addition, the Associate Quality Engineer supports the Senior Quality Engineer by facilitating and coordinating meetings and documentation related to deviations and investigations. This position is ideal for a recent graduate or early-career professional seeking hands-on experience in pharmaceutical quality engineering and regulated environments.

New Product Onboarding & Documentation Support

Support quality activities for new product onboarding, technology transfer, and project initiation efforts

Collaborate with Quality Engineers to draft and revise quality documentation including, but not limited to:

Stability protocols and reports

Finished good product specifications

Quality plans and project-specific quality documentation

Assist with document formatting, routing, review coordination, and approval workflows in document control systems

Support tracking of project onboarding deliverables, milestones, and quality-related action items

Work collaboratively with clients and internal cross-functional stakeholders to move projects forward.

Deviation & Investigation Coordination Support

Support the Senior Quality Engineer by coordinating and facilitating meetings related to deviations, investigations, and CAPA activities

Assist with document assembly and data gathering to support investigation records

Support timely communication between cross-functional stakeholders involved in investigations

Bachelor’s degree in chemistry, biology, or a related technical discipline with 2-3 years of pharma experience OR an advanced degree in chemistry, biology, or a related technical discipline with 1-2 years of pharma experience (or other regulated manufacturing setting)