August Bioservices, LLC

Associate Quality Engineer

Reposted 6 Days Ago

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Nashville, TN, USA

In-Office

Junior

Pharmaceutical

The Role

The Associate Quality Engineer supports quality activities related to new product onboarding and quality system execution, assisting with documentation and project coordination.

Summary Generated by Built In

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.

ESSENTIAL DUTIES & RESPONSIBILITIES

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

QUALIFICATIONS

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)

Basic understanding of pharmaceutical or regulated manufacturing environments
Strong attention to detail and organizational skills

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 every-day 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.

We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!

August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.

Skills Required

Bachelor's degree in chemistry, biology, or a related technical discipline
2-3 years of pharma experience OR an advanced degree with 1-2 years of pharma experience
Basic understanding of pharmaceutical or regulated manufacturing environments
Strong attention to detail and organizational skills

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The Company

HQ: Nashville, TN

81 Employees

Year Founded: 2017

What We Do

August Bioservices is a Contract Development and Manufacturing Organization (CDMO) headquartered in Nashville, Tennessee. August Bio offers a full range of pharmaceutical contract development and manufacturing services to pharmaceutical and biotech clients. We focus on sterile injectables, topicals, highly-complex formulations, poorly soluble & highly viscous compounds, Uncommon container sizes & fill volumes and offer aseptic and non-aseptic terminally sterilized filling of vials (liquid and lyophilized), syringes and flexible IV bags.