QA Validation & Calibration Specialist

St Jude Children's Research Hospital; Memphis (TN); On-site; USD 54,000 - 95,000; Full time

Benefits offered by this job

Medical & Prescription Drug Plans

Dental Plan

Vision Plan

Financial Security

Retirement Plan

Living Well - Employee WellnessProgram

Time Off Programs

Educational Benefits

Family Friendly Benefits

Benefits Unique to St. Jude

Job summary

St. Jude Children's GMP in Memphis, TN, is seeking a Quality Assurance Specialist to join our Validation and Calibration team.

You will validate, operate, calibrate, and monitor equipment and support systems used in manufacturing biologicals for human clinical trials, and help develop SOPs and protocols for validation and maintenance. Ideal candidates have a Bachelor's in chemistry or biology, 2+ years in quality/production, and familiarity with cGMP; Master's preferred.

Qualifications

• 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.

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.

Education

Bachelor's degree in chemistry, biology or related field

Master's degree preferred

Job description

St. Jude Children's GMP in Memphis, TN, is seeking a Quality Assurance Specialist to join our Validation and Calibration team.

You will validate, operate, calibrate, and monitor equipment and support systems used in manufacturing biologicals for human clinical trials, and help develop SOPs and protocols for validation and maintenance. Ideal candidates have a Bachelor's in chemistry or biology, 2+ years in quality/production, and familiarity with cGMP; Master's preferred.