Hybrid QA Manufacturing Operations Associate

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

Benefits offered by this job

Paid time off

Medical, dental, vision insurance

Company retirement plan

Wellness programs

Disability benefits

Job summary

Celltrion Branchburg, LLC seeks an Associate in QA Manufacturing Operations for a Wed-Sat night shift in Branchburg, NJ. The role focuses on GMP compliance, deviations, CAPA, MES review, and batch record verification.

Collaborative, detail-oriented candidates who thrive in a fast-paced biotech setting are encouraged to apply. The position involves supporting technology transfers, audits, and timely issue escalation, with exposure to regulatory guidelines and 21 CFR Part 11 compliance.

Qualifications

• Must possess working knowledge of GMP regulations and policies.
• Ability to function in a fast-paced environment and communicate with management.
• Ability to work in a cross-functional team environment.
• Ability to work independently and take initiative.
• Proficient in Microsoft applications (Office).
• Prior technical or QA experience in biotechnology manufacturing preferred.

Responsibilities

• Support Process Teams and provide guidance on quality issues.
• Evaluate deviations and ensure root cause analyses and CAPA effectiveness.
• Timely elevate issues to management as applicable.
• Perform data integrity analysis and Audit Trail Reviews.
• Perform MES exceptions / batch record review.
• Support lot release and regulatory inspections as needed.
• Assist in technology transfers and review development/validation docs.

Skills

GMP Regulations Knowledge

Cross-functional Teamwork

Communication Skills

Independent Working

Microsoft Office

Biotech QA Experience

Education

BA/BS in hard sciences

Tools

MES

QMS Systems

Job description

Celltrion Branchburg, LLC seeks an Associate in QA Manufacturing Operations for a Wed-Sat night shift in Branchburg, NJ. The role focuses on GMP compliance, deviations, CAPA, MES review, and batch record verification.

Collaborative, detail-oriented candidates who thrive in a fast-paced biotech setting are encouraged to apply. The position involves supporting technology transfers, audits, and timely issue escalation, with exposure to regulatory guidelines and 21 CFR Part 11 compliance.