Quality Assurance Manufacturing Associate — Wednesday–Saturday, 2nd Shift

Job overview

The Quality Assurance Manufacturing Associate works onsite in Somerville, NJ, on Wednesday through Saturday from 2:00 p.m. to 12:30 a.m. Compensation is $71,250–$118,750 per year. Celltrion develops and manufactures biopharmaceutical therapies and aims to expand access to advanced treatments. The role supports manufacturing process teams by maintaining quality systems and Good Manufacturing Practice compliance. It helps ensure production records, investigations, changes, and validations meet requirements and supports timely resolution of quality issues and lot release.

What you'll do

• Guide process teams on quality systems and GMP compliance
• evaluate deviations, root causes, and quality impacts
• recommend and track corrective and preventive actions
• conduct manufacturing walkthroughs and support changeovers
• perform data integrity analysis, audit trail reviews, and batch record reviews
• provide training and compliance guidance
• support lot release, technology transfers, validation documentation, and partner or regulatory audits
• coordinate with second-shift teams to resolve issues in real time.

What we're looking for

Skills & competencies

quality assurance

manufacturing associate

biopharmaceuticals

gmp compliance

deviation investigations

capa

batch record review

somerville nj

celltrion

wednesday–saturday

2nd shift

2:00 p.m.–12:30 a.m.

$71,250–$118,750

on-call availability

Work arrangement

• Weekend coverage required

Benefits & perks

• Paid time off, holidays and additional leave
• medical, dental, and vision insurance
• life insurance
• company-matched retirement savings plan
• wellness programs
• short- and long-term disability benefits.

Why this role

The posting states that the role requires up to 10% travel and on-call availability; hybrid flexibility may be available based on business needs.

About the employer

Celltrion Branchburg, LLC is hiring for this role. Industry: Biological Product (except Diagnostic) Manufacturing. Sector: 32.