GMP Quality Operations Specialist – Cell Therapy

MADE Scientific Inc; Princeton (NJ); On-site; USD 85,000 - 110,000; Full time

Job summary

Made Scientific is seeking a Quality Operations Specialist to join our team in a full-time, on-site role in the East Norriton, PA area. The position focuses on GMP-regulated clinical manufacturing oversight, batch record review, and on-floor quality support to ensure product quality and compliance.

The successful candidate will lead deviations and CAPAs, apply risk-based tools, and collaborate with Manufacturing, Quality Control, and Regulatory teams to drive continuous improvement and

Qualifications

• Bachelor’s degree in a relevant scientific discipline; 5+ years in pharma or GMP.
• Strong knowledge of batch record review, aseptic operations, cGMP (21 CFR 210, 211, 1271).
• Proven ability to lead investigations and develop CAPAs.

Responsibilities

• Provide on-floor Quality Operations support for manufacturing, warehouse, and other operations.
• Review and approve GMP documentation, batch records, SOPs, and test methods.
• Lead investigations into deviations and CAPAs using root cause analysis.
• Collaborate across Manufacturing, Quality Control, and Supply Chain to resolve issues.
• Support internal audits, facility walks, and regulatory inspections.

Education

Bachelor’s degree in a relevant scientific discipline

Tools

Veeva

Job description

Made Scientific is seeking a Quality Operations Specialist to join our team in a full-time, on-site role in the East Norriton, PA area. The position focuses on GMP-regulated clinical manufacturing oversight, batch record review, and on-floor quality support to ensure product quality and compliance.

The successful candidate will lead deviations and CAPAs, apply risk-based tools, and collaborate with Manufacturing, Quality Control, and Regulatory teams to drive continuous improvement and