Quality Assurance Specialist at St. Jude Children's GMP

We are seeking a Quality Assurance Specialist to join our Validation and Calibration team at the Children’s GMP e Children’s Research Hospital. The World’s Best Stop at Nothing There’s a reason St. Jude Children’s Research Hospital is consistently ranked on Glassdoor’s “Best Places to Work” list. Actually, there’s more than 5,500 reasons. At our world-class pediatric research hospital, every one of our 5,500 professionals shares our commitment to making a difference in the lives of the children we serve.

There’s a unique bond when you are part of a team that will stop at nothing to advance the treatments and cures of pediatric catastrophic diseases. The result is a collaborative, positive environment where all employees, regardless of their role, receive the resources, support, and encouragement to advance and grow their careers. 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. 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.

• 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.

• 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.

Your health and well-being are important to us. That's why St. Jude Children's Research Hospital provides employees with high-quality benefits choices. We are committed to ensuring our benefits are competitive and affordable. St. Jude continues to cover medical premiums for employees and offers low additional costs for dependents.

• Medical & Prescription Drug Plans
• Dental Plan
• Vision Plan
• Financial Security
• Retirement Plan
• Living Well - Employee Wellness Program
• Time Off Programs
• Educational Benefits
• Family Friendly Benefits
• Benefits Unique to St. Jude

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