Quality Operations Specialist III - 3rd Shift Cell Therapy

MADE Scientific Inc; Princeton (NJ); On-site; USD 90,000 - 110,000; Full time

Job summary

Made Scientific is seeking a Quality Operations Specialist III to join our Princeton, NJ team on a 3rd shift (Wed–Sat). The role provides hands-on QA oversight for GMP-regulated clinical manufacturing, ensuring cGMP compliance and timely product disposition.

The ideal candidate has 5+ years in pharma/GMP, strong CAPA and investigation skills, and the ability to lead cross-functional quality activities in a fast-paced environment.

Qualifications

• Bachelor’s degree in a scientific field with 5+ years in pharma or GMP.
• 3–5 years QA in GMP, ideally with cell or gene therapy.
• Strong knowledge of batch record review, aseptic ops, and cGMP (21 CFR 210, 211, 1271).
• Proven ability to lead investigations and develop CAPAs.
• Proficient in Fishbone, 5 Whys, FMEA, and risk-based tools.
• Ability to work independently and manage multiple priorities.

Responsibilities

• Provide on-floor quality operations support for GMP manufacturing and related activities.
• Review and approve GMP documentation (batch records, SOPs, test methods).
• Lead deviations, non-conformances, and CAPA investigations.
• Collaborate with Manufacturing, Quality Control, and Supply Chain teams.
• Support internal audits and regulatory inspections.
• Escalate quality issues promptly to enable timely lot release.

Skills

QA experience

GMP knowledge

Investigation leadership

cGMP compliance

Root cause analysis

Education

Bachelor's degree

Tools

Veeva

Job description

Made Scientific is seeking a Quality Operations Specialist III to join our Princeton, NJ team on a 3rd shift (Wed–Sat). The role provides hands-on QA oversight for GMP-regulated clinical manufacturing, ensuring cGMP compliance and timely product disposition.

The ideal candidate has 5+ years in pharma/GMP, strong CAPA and investigation skills, and the ability to lead cross-functional quality activities in a fast-paced environment.