Supervisor, Quality Control GMP- Winship Cancer Institute

Emory University•Atlanta, GA

3h•Onsite

About The Position

Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community. Dedicated to discovering cures for cancer and inspiring hope, Winship Cancer Institute of Emory University is Georgia’s only National Cancer Institute-designated Comprehensive Cancer Center, a prestigious distinction given to the top tier of cancer centers nationwide for making breakthroughs against cancer. Winship is researching, developing, teaching, and providing novel and highly effective ways to prevent, detect, diagnose, treat, and survive cancer. Cancer care at Winship includes leading cancer specialists collaborating across disciplines to tailor treatment plans to each patient’s needs and type of cancer; innovative therapies and clinical trials; comprehensive patient and family support services; and a personalized care experience aimed at easing the burden of cancer. Winship is Where Science Becomes Hope®. For more information, visit winshipcancer.emory.edu. Winship is seeking qualified candidates for the Supervisor, Quality Control GMP position.

Requirements

Bachelor's degree
Five years of research/lab experience
At least one year in supervisory or lead role
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
Experience with specific assays (sterility, endotoxin) is often required

Nice To Haves

Hands-on experience with QX testing and documentation review
GMP experience preferred

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, and maintains compliance with FDA, cGMP, and internal quality standards.
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.
Ensures data integrity and ALCOA+ principles are followed.
Supervises, coaches, and trains QC analysts and technicians.
Schedules work, manages workload, and ensures coverage for testing activities.
Conducts performance reviews and support development plans.
Enforces laboratory safety and compliance culture.
Oversees testing of raw materials, in-process, drug substance, and/or drug product.
Ensures timely completion of testing to support manufacturing and release timelines.
Maintains laboratory instruments, qualification, and calibration status.
Supports method transfer, validation, and troubleshooting.
Writes and reviews SOPs, forms, protocols, reports, and batch-related documentation.
Maintains training records and competency assessments.
Partners with Manufacturing, QA, Engineering, and Supply Chain.
Supports investigations related to testing or stability issues.
Contributes to continuous improvement initiatives.
Performs Related Responsibilities as required.