Quality Assurance Specialist at St. Jude Children's GMP
St. Jude Children's Research Hospital
Summary
This role is responsible for performing activities related to the validation, operation, calibration, and monitoring of equipment and support systems used in the manufacturing process of biologicals for human clinical trials. The selected candidate will help develop SOPs and protocols specific to validation, calibration, and maintenance of process equipment and facility support systems.
Job description
Our ideal candidate has great attention to detail and time management skills and is adept at problem solving and multitasking. Adaptability and teamwork are a must. A working knowledge of quality standards is also desired along with excellent written and verbal communication. Any experience with software suites and computer technology is a strong preference.
Job Responsibilities
- Coordinate and execute quality/production processes with guidance, to monitor and ensure compliance with all applicable regulatory requirements (e.g., FDA, USDA, FACT).
- Provide inputs regarding revisions to SOPs and/or process flows related to production/quality/TPQ/HAL within area.
- As directed, routinely monitor production to ensure cGMP compliance by checking batch records for accuracy and equipment logs for completeness.
- Assist with internal/external audits, investigation of deviations, and identification/implementation of corrective actions.
- Support documentation related to compliance with quality and regulatory requirements.
- Assist in the continuous improvement system using documentation such as release specifications, variances, environmental monitoring reports, and internal audits.
- Perform other duties as assigned to meet the goals and objectives of the department and institution.
- Maintains regular and predictable attendance.
Minimum Education and/or Training
- Bachelor's degree in chemistry, biology or related field required.
- Master's degree preferred.
Minimum Experience
- Minimum Requirement: 2+ years of quality/production experience in industry setting required.
- Some prior experience working with quality/manufacturing regulations and guidelines (e.g., cGMP, cGTP, FACT) preferred.
- Familiarity with electronic systems commonly used in Quality Management Systems preferred.
- Experience working with computerized databases preferred.
Requirements
- Bachelor's degree in chemistry, biology or related field required.
- Master's degree preferred.
- Minimum Requirement: 2+ years of quality/production experience in industry setting required.
- Some prior experience working with quality/manufacturing regulations and guidelines (e.g., cGMP, cGTP, FACT) preferred.
- Familiarity with electronic systems commonly used in Quality Management Systems preferred.
- Experience working with computerized databases preferred.
Benefits
- Medical & Prescription Drug Plans
- Dental Plan
- Vision Plan
- Financial Security
- Retirement Plan
- Employee Wellness Program
- Time Off Programs
- Educational Benefits
- Family Friendly Benefits
Company overview
St. Jude Children's Research Hospital is a world-renowned pediatric research and treatment institution headquartered in Memphis, Tennessee, dedicated to advancing cures for childhood cancer and other catastrophic diseases. Founded in 1962 by entertainer Danny Thomas, it stands as the first and only National Cancer Institute-designated Comprehensive Cancer Center devoted exclusively to children. The hospital operates on a unique funding model where families never receive bills for treatment, travel, housing, or food, with costs exceeding $2 billion annually primarily supported by donations through its fundraising organization ALSAC. St. Jude treats approximately 8,600 patients each year from all 50 states and around the world, with a focus on acute lymphoblastic leukemia, brain tumors, sickle cell disease, and infectious diseases. The institution employs over 7,000 staff members and maintains eight affiliate clinics across the United States. Through its St. Jude Global initiative, the hospital shares research and treatment protocols internationally, partnering with more than 350 institutions in over 90 countries. St. Jude has been instrumental in increasing childhood cancer survival rates from 20% in 1962 to over 80% today, while maintaining a robust research program that includes gene therapy, bone marrow transplantation, and precision medicine approaches.