August Bioservices

August Bioservices

Product Quality Assurance Supervisor

Nashville, Tennessee

Sponsorship not specifiedDetected 4 days ago
Performance ManagementGMPFDA RegulatoryLeadershipCommunicationMentoringWritingMicrosoft OfficeGxP

About the role

  • 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).
  • The Product Quality Assurance Supervisor is responsible for the daily leadership and execution of the Acceptable Quality Level (AQL) and Quality on the Floor (QAOTF) programs.
  • This position provides direct supervision of QA Specialists supporting manufacturing operations, ensuring continuous quality oversight of production activities, visual inspection programs, and real-time GMP compliance.

Responsibilities

  • Manage the Quality Assurance AQL and visual inspection program.
  • Maintain AQL visual inspection qualification programs.
  • Partner with Manufacturing to establish inspection standards and qualification requirements.
  • Partner with Manufacturing leadership to coordinate QAOTF support.
  • Support and review investigations, deviations, CAPAs, and change controls impacting manufacturing operations.
  • Support batch record review and batch disposition/release activities.
  • Identify compliance risks and implement corrective actions.
  • Build collaborative relationships across Manufacturing, QC, Validation, Engineering, and Supply Chain.
  • 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.

Requirements

  • Master's Degree and 2+ years' experience in Quality Assurance or a DEA related field within a biotechnology, biologics, or pharmaceutical manufacturing facility OR Bachelor's Degree and 3+ years' experience in Quality Assurance or a DEA related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
  • 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
  • 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.

Nice to have

  • responsible and engaged citizens within our communities
  • and active, mindful stewards of our environment.

Skills

  • Root Cause Analysis Tools, Risk Management, Technical Writing, Microsoft Office applications, eQMS and LIMS systems
  • Strong communication, leadership, and organizational skills.

Benefits

  • For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!
  • shift coverage to support manufacturing operations, including evenings and weekends.
  • Ensure appropriate QA coverage for production schedules.

This listing is sourced directly from August Bioservices's careers page and normalized into a canonical job model.