Quality Assurance Specialist at St. Jude Children's GMP
About The Position
St. Jude Children’s GMP is seeking a Quality Assurance Specialist to join its Validation and Calibration team. This role performs activities related to the validation, operation, calibration, and monitoring of equipment and support systems used to manufacture biologicals for human clinical trials. The specialist also helps develop SOPs and protocols for validation, calibration, and maintenance of process equipment and facility support systems. The position coordinates and supports quality and production processes to help ensure compliance with applicable regulatory requirements. The ideal candidate has strong attention to detail, time management, problem-solving, multitasking, adaptability, and teamwork skills, along with excellent written and verbal communication. Working knowledge of quality standards is desired; 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.
- Strong 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.
- Working knowledge of quality standards.
- Experience with software suites and computer technology.
Responsibilities
- Coordinate and execute quality and production processes, with guidance, to monitor and ensure compliance with applicable regulatory requirements, including FDA, USDA, and FACT requirements.
- Provide input on revisions to SOPs and process flows related to production, quality, TPQ, or HAL within the area.
- Routinely monitor production, as directed, to ensure cGMP compliance by checking batch records for accuracy and equipment logs for completeness.
- Assist with internal and external audits, investigation of deviations, and identification and implementation of corrective actions.
- Support documentation related to quality and regulatory compliance requirements.
- Assist with continuous improvement activities 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; St. Jude covers employee medical premiums and offers low additional costs for dependents.
- 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.
- On-campus conveniences.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
