Supervisor, Quality Control GMP- Winship Cancer Institute

About Winship Cancer Institute of Emory University

Dedicated to discovering cures for cancer and inspiring hope Winship Cancer Institute of Emory University is Georgias 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 patients 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 is Where Science Becomes Hope. For more information visit .

Winship is seeking qualified candidates for the Supervisor Quality Control GMP position. Position details are as follows:

JOB DESCRIPTION:

• 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.

MINIMUM QUALIFICATIONS:

• Bachelors degree and five years of research/lab experience with at least one year in supervisory or lead role.

PREFERRED QUALIFICATIONS:

• Hands-on experience with QX testing and documentation review. GMP experience preferred.
• Essential Skills & Qualifications: Strong knowledge of GMP principles and quality processes. 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.