Associate Quality Engineer
About The Position
August Bioservices, headquartered in Nashville, TN, is a privately-owned, high-growth Contract Development Manufacturing Organization (CDMO) providing expert drug discovery, drug formulation, and drug manufacturing services to pharmaceutical and biotech companies. The company is undergoing a significant two-phase expansion, including a new state-of-the-art facility. The Associate Quality Engineer supports quality activities for new product introduction and projects within the quality system, working with Quality Engineers on documentation development, project coordination, and quality system execution during new product onboarding. Additionally, this role assists the Senior Quality Engineer in facilitating and coordinating meetings and documentation for deviations and investigations. This position is suitable for recent graduates or early-career professionals seeking hands-on experience in pharmaceutical quality engineering and regulated environments.
Requirements
- 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
Responsibilities
- 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.
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
11-50 employees
