Quality Operations Specialist - GMP Cell Therapy

Made Scientific, Inc.; Princeton (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Made Scientific in Princeton, NJ, is seeking a Quality Operations Specialist III to provide hands-on QA oversight for GMP-regulated clinical manufacturing and technical operations. You will review batch records, approve GMP documentation, and support product disposition and release.

You will lead investigations into deviations, CAPAs, and environmental excursions, applying root-cause analysis and risk-based decision making to ensure compliant, timely resolutions and continuous improvement.

Qualifications

• 5+ years in pharmaceutical or GMP industry.
• Experience with cell therapy or biologics is a plus.
• Knowledge of 21 CFR Parts 210, 211, 1271 and ICH/FDA guidance.

Responsibilities

• Provide on-floor QA support for GMP manufacturing and operations.
• Review and approve GMP batch records, SOPs, and test methods.
• Assist with batch disposition and product release activities.
• Lead investigations into deviations, non-conformances, and CAPAs.
• Collaborate with Manufacturing, QC, and Supply Chain to resolve issues.

Skills

On-floor QA oversight

GMP compliance

Batch record review

CAPA investigations

Root cause analysis

Regulatory documentation

Cross-functional collaboration

Education

Bachelor’s degree in a scientific discipline

Tools

Veeva

Job description

Made Scientific in Princeton, NJ, is seeking a Quality Operations Specialist III to provide hands-on QA oversight for GMP-regulated clinical manufacturing and technical operations. You will review batch records, approve GMP documentation, and support product disposition and release.

You will lead investigations into deviations, CAPAs, and environmental excursions, applying root-cause analysis and risk-based decision making to ensure compliant, timely resolutions and continuous improvement.