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Memphis, TN
Source: St. Jude careers · View original posting
From St. Jude's posting. “We” and “our” refer to the employer.
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.
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.
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.
Mater'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.
Compensation
In recognition of certain U.S. state and municipal pay transparency laws, St. Jude is including a reasonable estimate of the compensation range for this role. This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs.
It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $54,080 - $94,640 per year for the role of Quality Assurance Specialist at St. Jude Children's GMP.
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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 .
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.
St. Jude is an Equal Opportunity Employer
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
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