Quality Assurance Specialist at St. Jude Children's GMP

St. Jude Children's Research Hospital • Memphis, TN

5d

About The Position

The Quality Assurance Specialist joins the Validation and Calibration team at the Children’s GMP at St. Jude Children’s Research Hospital. The role performs activities related to validation, operation, calibration, and monitoring of equipment and support systems used to manufacture biologicals for human clinical trials. The specialist helps develop SOPs and protocols for validation, calibration, and maintenance of process equipment and facility support systems. The position coordinates and executes quality and production processes with guidance to support compliance with applicable regulatory requirements. The ideal candidate demonstrates attention to detail, time management, problem-solving, multitasking, adaptability, teamwork, knowledge of quality standards, and strong written and verbal communication. Experience with software suites and computer technology is preferred.

Requirements

• Bachelor's degree in chemistry, biology, or a related field.
• At least 2 years of quality or production experience in an industry setting.
• Excellent written and verbal communication skills.
• Attention to detail, time management, problem-solving, and multitasking skills.
• Adaptability and teamwork.

Nice To Haves

• Master's degree.
• Prior experience with quality or manufacturing regulations and guidelines, such as cGMP, cGTP, or FACT.
• Familiarity with electronic systems commonly used in Quality Management Systems.
• Experience working with computerized databases.
• Experience with software suites and computer technology.
• Working knowledge of quality standards.

Responsibilities

• Coordinate and execute quality and production processes with guidance to monitor and ensure compliance with applicable regulatory requirements, including FDA, USDA, and FACT.
• Provide input on revisions to SOPs and process flows related to production, quality, TPQ, and HAL within the area.
• Routinely monitor production as directed to ensure cGMP compliance, including checking batch records for accuracy and equipment logs for completeness.
• Assist with internal and external audits, investigate deviations, and identify and implement corrective actions.
• Support documentation related to quality and regulatory compliance.
• Assist with the continuous improvement system using documentation such as release specifications, variances, environmental monitoring reports, and internal audits.
• Perform other duties as assigned to meet department and institutional goals and objectives.
• Maintain regular and predictable attendance.

Benefits

• Medical and prescription drug plans
• Dental plan
• Vision plan
• Financial security benefits
• Retirement plan
• Employee wellness program
• Time-off programs, including generous paid time off
• Educational benefits
• Family-friendly benefits
• Benefits unique to St. Jude
• Medical premiums covered for employees, with low additional costs for dependents
• On-campus conveniences

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level