Quality Assurance Specialist at St. Jude Children's GMP
Core
Ensuring compliance with regulatory requirements (FDA, USDA, FACT) for the validation, operation, calibration, and monitoring of equipment and support systems used in the manufacturing of biologicals for human clinical trials.
Role type
Quality Assurance Specialist (Manufacturing/Validation)
Builds
Biological products for human clinical trials
Domain
Healthcare / Biopharmaceutical Manufacturing
Required skills
Regulatory compliance knowledge (cGMP, cGTP, FACT), SOP development, batch record review, deviation investigation, corrective action implementation, quality documentation, equipment monitoring
Preferred skills
Master's degree in chemistry/biology, experience with Quality Management Systems (QMS), computerized databases, electronic systems
Technologies
Quality Management Systems (QMS), computerized databases
Responsibilities
Coordinate and execute quality/production processes to ensure regulatory compliance; Provide inputs regarding revisions to SOPs and process flows; Monitor production to ensure cGMP compliance by checking batch records and equipment logs; Assist with internal/external audits, deviation investigations, and corrective actions; Support documentation related to quality and regulatory requirements; Assist in continuous improvement systems using environmental monitoring reports and internal audits.
Seniority
Mid-level, hands-on IC