Quality Assurance Specialist at St. Jude Children's GMP

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 are 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.

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.
• Mater'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.

Benefits

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.

View all the benefits offered including 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, and Benefits Unique to St. Jude.

Have More in Memphis

Get the best of big-city amenities mixed with all the charm of a small-town feel when you live in Memphis. From our world-renowned music scene to our eclectic mix of food and people. Memphis is a place our employees are proud to call home. Our region enjoys a cost of living more than 20% lower than the national average and our state places no personal income tax on wages. Plus, Memphians spend five hours less per year in their daily commute compared to the national average. Learn how you can "Have More in Memphis."

Better at Work. Better at Life.

When you work at St. Jude, you'll join a highly collaborative work culture that inspires you every day to be your best. With opportunities for learning and growth, you can shape a career path that is right for you while also enjoying all the benefits and stability of working for a world-class institution. This includes work-life balance with generous paid time-off and on-campus conveniences that make life a little easier. Join us and you'll quickly see why St. Jude is consistently ranked by our employees on Glassdoor as a "Best Place to Work."

Compensation

Explore our exceptional benefits!

We are committed to a human-centered hiring experience. Technology may support portions of our process, but recruiting decisions involve human review and engagement. Learn more about our approach to AI.

St. Jude is an Equal Opportunity Employer

No Search Firms

St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.