QA Coordinator — GDP Compliance & Quality Systems

Celltrion USA; Jersey City (NJ); On-site; USD 85,000 - 120,000; Full time

Job summary

Celltrion USA in New Jersey seeks a Quality Assurance professional to support the management of quality systems for distributed products under GDP and 21 CFR parts. You will report to the QA Manager, review quality system SOPs, and assist with audits, training, and continuous improvement to ensure compliance with QSR requirements and CELLTRION USA policies.

The role requires 3–5 years in QA in pharma or biotech, strong knowledge of QMS and GDP, and excellent communication to collaborate with

Qualifications

• 3–5 years in QA within pharma/biotech or GDP of biopharma products.
• Strong knowledge of Quality Management Systems (QMS) and GDP.

Responsibilities

• Support quality systems management for distributed products per GDP and 21 CFR Part 210/211 or Part 820.
• Review and approve quality activities and SOPs; assist audits and training.
• Collaborate with QA team and cross-functional groups to improve quality processes.

Skills

Quality Assurance

GDP knowledge

FDA/regulatory knowledge

QMS

Communication

Education

Bachelor’s degree

Job description

Celltrion USA in New Jersey seeks a Quality Assurance professional to support the management of quality systems for distributed products under GDP and 21 CFR parts. You will report to the QA Manager, review quality system SOPs, and assist with audits, training, and continuous improvement to ensure compliance with QSR requirements and CELLTRION USA policies.

The role requires 3–5 years in QA in pharma or biotech, strong knowledge of QMS and GDP, and excellent communication to collaborate with