Quality Assurance Specialist at St. Jude Children's GMP

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

2d • $54,080 - $94,640 • Onsite

About The Position

We are seeking a Quality Assurance Specialist to join our Validation and Calibration team at the Children’s GMP at St. Jude Children’s Research Hospital. 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.

Requirements

• Bachelor's degree in chemistry, biology or related field required.
• Minimum Requirement: 2+ years of quality/production experience in industry setting required.
• 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.
• Excellent written and verbal communication.

Nice To Haves

• Mater's degree preferred.
• 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.
• A working knowledge of quality standards is also desired.
• Any experience with software suites and computer technology is a strong preference.

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.

Benefits

• 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
• St. Jude continues to cover medical premiums for employees and offers low additional costs for dependents.

What This Job Offers

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