QA Manufacturing Ops Associate — 2nd Shift, Hybrid

Celltrion Branchburg; Branchburg Township (NJ); Hybrid; USD 71,000 - 119,000; Full time

Job summary

Celltrion Branchburg, LLC is seeking a Quality Assurance Manufacturing Associate to support the Process Team in ensuring GMP compliance and robust Quality Systems. The role involves deviation investigations, change control, master production record reviews, validations and MES exception/batch record reviews, with QA presence in Manufacturing areas.

You will participate in audits, support technology transfers, and assist with on-time performance, training, and regulatory compliance (21 CFR Part

Qualifications

• Working knowledge of domestic and international GMP regulations.
• Ability to function in a fast-paced environment and communicate with management.
• Ability to work in a cross-functional team and independently.

Responsibilities

• Support deviation investigations, CAPA, change control, and MES/batch record reviews.
• Provide QA presence in manufacturing areas and assist during inspections.

Skills

GMP regulations knowledge

Cross-functional collaboration

Effective communication

Independent work capability

Microsoft applications proficiency

Biotech manufacturing QA experience

Education

BA/BS degree in hard sciences

Job description

Celltrion Branchburg, LLC is seeking a Quality Assurance Manufacturing Associate to support the Process Team in ensuring GMP compliance and robust Quality Systems. The role involves deviation investigations, change control, master production record reviews, validations and MES exception/batch record reviews, with QA presence in Manufacturing areas.

You will participate in audits, support technology transfers, and assist with on-time performance, training, and regulatory compliance (21 CFR Part