Biotech QA Manufacturing Associate — 2nd Shift

Socket.dev; Branchburg Township (NJ); Hybrid; USD 71,000 - 119,000; Full time

Benefits offered by this job

PTO

Medical insurance

Dental insurance

Vision insurance

Life insurance

Retirement plan

Wellness program

Disability benefits

Job summary

Celltrion Branchburg, LLC is seeking a Quality Assurance Manufacturing Associate to support GMP compliance on the 2nd shift in the Branchburg facility. The role provides QA presence on the manufacturing floor, participates in deviation investigations, change controls, and MES/batch record reviews to ensure product quality.

You will collaborate with Downstream Process Teams, assist technology transfers, and support regulatory inspections.

Qualifications

• BA/BS in hard sciences with 1–3 years in Biopharmaceutical industry preferred.
• Must understand GMP/regulatory guidelines and be able to work in a fast-paced environment.
• Experience in biotechnology manufacturing processes and/or computer systems is preferred.

Responsibilities

• Support deviation investigations and CAPA recommendations.
• Review batch records and MES exceptions/batch records.
• Assist in technology transfers to/from Celltrion Branchburg facilities.
• Ensure compliance with 21 CFR Part 11 and Annex 11.
• Coordinate with manufacturing and QA teams to resolve issues in real time.
• Attend regulatory inspections as needed.

Skills

GMP compliance

Cross-functional

Quality systems

Data integrity

MS Office

Education

BA/BS in hard sciences

Tools

MES

Microsoft Office

Job description

Celltrion Branchburg, LLC is seeking a Quality Assurance Manufacturing Associate to support GMP compliance on the 2nd shift in the Branchburg facility. The role provides QA presence on the manufacturing floor, participates in deviation investigations, change controls, and MES/batch record reviews to ensure product quality.

You will collaborate with Downstream Process Teams, assist technology transfers, and support regulatory inspections.