Quality Assurance Specialist, Validation & Calibration

Children's GMP, LLC

Memphis (TN)

On-site

USD 54,000 - 95,000

Full time

14 days+

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Benefits offered by this job

Medical & Prescription Drug Plans

Dental Plan

Vision Plan

Retirement Plan

Wellness Program

Time Off Programs

Educational Benefits

Family Friendly Benefits

Benefits Unique to St. Jude

Job summary

St. Jude Children's Research Hospital in Memphis is seeking a Quality Assurance Specialist to join the Validation and Calibration team.

The role involves validating, operating, calibrating, and monitoring equipment and support systems used in manufacturing biologicals for human clinical trials. The ideal candidate will have a Bachelor's in chemistry or biology, 2+ years in quality or production, familiarity with cGMP, and strong documentation and communication skills.

Qualifications

Minimum 2+ years of quality/production experience in an industrial setting.
Some experience with quality/manufacturing regulations and guidelines (e.g., cGMP, cGTP, FACT) preferred.
Familiarity with electronic systems used in Quality Management Systems.

Responsibilities

Coordinate and execute quality/production processes to monitor and ensure regulatory compliance (FDA, USDA, FACT).
Assist with revisions to SOPs and process flows related to production/quality.
Monitor production to ensure cGMP compliance by reviewing batch records and equipment logs.
Assist in audits, investigations of deviations, and implementation of corrective actions.
Support documentation related to compliance with quality and regulatory requirements.