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Emory University

Quality Control Supervisor - GMP

1w

Emory University

Atlanta, US · Full-time · $90,000 – $120,000

About this role

Winship Cancer Institute of Emory University is Georgia’s only National Cancer Institute-designated Comprehensive Cancer Center, dedicated to discovering cures for cancer. The Supervisor, Quality Control GMP oversees GMP-compliant laboratory operations to ensure the safety, identity, strength, purity, and quality of products. This role supports novel therapies, clinical trials, and personalized cancer care at Winship, where science becomes hope.

Leads QC analysts and technicians to perform accurate and timely testing while maintaining compliance with FDA, cGMP, and internal quality standards. Reviews laboratory records, deviations, OOS/OOT, CAPAs, and change controls. Ensures data integrity and adherence to ALCOA+ principles in all QC activities.

Supervises, coaches, and trains team members, schedules work, manages workload, and conducts performance reviews. Oversees testing of raw materials, in-process, drug substance, and drug product to meet manufacturing and release timelines. Maintains laboratory instruments, qualification, and calibration status.

Partners with Manufacturing, QA, Engineering, and Supply Chain to support investigations, method transfer, validation, and troubleshooting. Writes and reviews SOPs, protocols, reports, and batch documentation. Contributes to regulatory inspections, audits, continuous improvement initiatives, and a laboratory safety culture.

Emory University fosters excellence, attracting world-class talent to innovate and prepare leaders. Join a leading research university contributing to the academic community’s breakthroughs against cancer.

Requirements

  • Bachelor's degree and five years of research/lab experience with at least one year in supervisory or lead role
  • Hands-on experience with QC testing and documentation review
  • GMP experience preferred
  • Strong knowledge of GMP principles and quality processes
  • Excellent attention to detail, analytical, and problem-solving skills
  • Strong written and verbal communication
  • Ability to follow detailed procedures (SOPs) accurately
  • Familiarity with lab instruments, data systems, and Microsoft Office

Responsibilities

  • Oversees GMP-compliant laboratory operations to ensure the safety, identity, strength, purity, and quality of products
  • Leads QC analysts/technicians, ensures testing is performed accurately and on time
  • Ensures all QC activities comply with cGMP, FDA regulations, and internal SOP
  • Supports regulatory inspections, audits, and responses
  • Reviews and completes laboratory records, deviations, OOS/OOT, CAPAs, change controls
  • Supervises, coaches, and trains QC analysts and technicians
  • Schedules work, manages workload, and ensures coverage for testing activities
  • Partners with Manufacturing, QA, Engineering, and Supply Chain

Benefits

  • Equal opportunity employer