QA & Validation Specialist, Biotech & cGMP

St. Jude; Lauderdale Courts (TN); On-site; USD 54,000 - 95,000; Full time

Job summary

St. Jude Children's Research Hospital seeks a Quality Assurance Specialist to oversee validation, calibration, and monitoring of process equipment used in biopharma manufacturing for clinical trials.

You will help develop SOPs for validation, calibration, and facility systems, ensuring accuracy and compliance across operations. The ideal candidate brings detail orientation, time management, problem solving, and teamwork, with strong written and verbal communication and familiarity with quality

Qualifications

• Bachelor’s degree in chemistry, biology or related field required; Master’s preferred.
• 2+ years of quality/production experience in industry setting.
• Experience with quality/regulatory standards (cGMP, cGTP, FACT) preferred.
• Familiarity with electronic systems and computerized databases preferred.

Responsibilities

• Coordinate and execute quality/production processes to monitor regulatory compliance.
• Provide inputs revising SOPs and process flows in production/quality areas.
• Monitor production for cGMP compliance by reviewing batch records and logs.
• Assist audits, investigate deviations, and implement corrective actions.
• Support documentation for quality and regulatory compliance.
• Contribute to continuous improvement using related documentation and audits.
• Perform other duties to meet department goals and maintain attendance.

Skills

Attention to detail

Time management

Problem solving

Multitasking

Adaptability

Teamwork

Communication

Software proficiency

Education

Bachelor's degree in chemistry, biology or related field

Master's degree preferred

Tools

Computer software suites

Job description

St. Jude Children's Research Hospital seeks a Quality Assurance Specialist to oversee validation, calibration, and monitoring of process equipment used in biopharma manufacturing for clinical trials.

You will help develop SOPs for validation, calibration, and facility systems, ensuring accuracy and compliance across operations. The ideal candidate brings detail orientation, time management, problem solving, and teamwork, with strong written and verbal communication and familiarity with quality