QA Manufacturing Associate - 2nd Shift (GMP & Data Integrity)

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

Job summary

Celltrion Branchburg, LLC is seeking an Associate - QA Manufacturing Operations for the 2nd shift (Wed-Sat, 2pm–12:30am) in Branchburg, NJ. The role provides QA presence in manufacturing, conducts deviation investigations, change control assessments, and batch record reviews to ensure GMP compliance and data integrity.

BA/BS in hard sciences is required, with 1–3 years in biopharma preferred. Strong communication, cross‑functional collaboration, and proficiency with Microsoft applications are

Qualifications

• Must know domestic and international GMP regulations.
• Ability to work in fast-paced environment and communicate with management.
• Able to work in cross-functional teams.
• Must work independently.
• Proficient in Microsoft applications.
• Biotech manufacturing experience preferred.

Responsibilities

• Support and guide Process Teams and customers.
• Evaluate deviations and ensure root cause analysis; recommend CAPAs.
• Escalate issues to management promptly.
• Conduct periodic walk-throughs and support facility changeovers.
• Perform Data Integrity Analysis and Audit Trail Reviews.
• Review MES exceptions and batch records.
• Provide training within the group or organization.
• Support lot release and timely resolution of compliance issues.
• Assist in tech transfers between facilities.
• Review and approve development and validation docs.
• Identify and evaluate change controls and risk assessments.
• Support on-time performance metrics.
• Assist audits by partners, Celltrion corporate, and regulators.
• Ensure compliance with 21 CFR Part 11, Annex 11, etc.
• Support floor time program.
• Escalate critical quality issues.
• Coordinate with second shift to resolve issues in real time.

Skills

GMP knowledge

Cross-functional

Independent work

Communication

Microsoft Office

Education

BA/BS in hard sciences

Tools

Microsoft Office

Job description

Celltrion Branchburg, LLC is seeking an Associate - QA Manufacturing Operations for the 2nd shift (Wed-Sat, 2pm–12:30am) in Branchburg, NJ. The role provides QA presence in manufacturing, conducts deviation investigations, change control assessments, and batch record reviews to ensure GMP compliance and data integrity.

BA/BS in hard sciences is required, with 1–3 years in biopharma preferred. Strong communication, cross‑functional collaboration, and proficiency with Microsoft applications are