Cell Therapy Quality Operations Lead

Made Scientific, Inc.; Eagleville (PA); On-site; USD 90,000 - 125,000; Full time

Job summary

Made Scientific is seeking a Quality Operations Specialist III to provide hands-on QA oversight for GMP-regulated clinical manufacturing processes in East Norriton, PA. The role includes on-the-floor QA support, review and approval of batch records and SOPs, and leading quality investigations with robust CAPAs.

The ideal candidate has a strong background in cGMP, aseptic operations, and risk-based quality systems, with experience in CDMOs or biologics.

Qualifications

• Bachelor’s degree in a relevant scientific discipline with 5+ years of experience in the pharmaceutical or GMP industry.
• 3-5 years of QA experience in a GMP-regulated environment, ideally with cell therapy, gene therapy, or other advanced biologics; CDMO experience strongly preferred.

Responsibilities

• Provide on-floor Quality Operations (QO) support for manufacturing, warehouse, and other technical operations, including in-process checks, deviation identification, and adherence to cGMP expectations.
• Review and approve GMP documentation (e.g., batch records, SOPs, test methods, validation protocols, technical reports) for accuracy and compliance.
• Lead and close complex quality investigations, including root cause analysis and development of effective CAPAs.
• Collaborate cross-functionally with Manufacturing, Quality Control, and Supply Chain teams to resolve quality issues.
• Represent the Quality Operations department in team discussions and project meetings; keep management informed of progress and risks.
• Support internal audits, facility walkthroughs, and regulatory inspections; participate in continuous improvement initiatives.

Skills

Batch record review

Aseptic operations

cGMP regulations

Root cause analysis

CAPA

QA on-the-floor

Investigation tools

Education

Bachelor’s degree in a relevant scientific discipline

Tools

Veeva

Job description

Made Scientific is seeking a Quality Operations Specialist III to provide hands-on QA oversight for GMP-regulated clinical manufacturing processes in East Norriton, PA. The role includes on-the-floor QA support, review and approval of batch records and SOPs, and leading quality investigations with robust CAPAs.

The ideal candidate has a strong background in cGMP, aseptic operations, and risk-based quality systems, with experience in CDMOs or biologics.