GMP Quality Assurance Associate I

Abzena; Bristol Township (Bucks County); On-site; USD 60,000 - 85,000; Full time

Job summary

Abzena in the United States is seeking an Associate I, Quality Operations to provide day-to-day QA oversight and documentation review to support GMP manufacturing of intermediates and drug substances. The role ensures production activities are executed in compliance with cGMP requirements through on-floor QA presence, batch record review, and support of batch disposition.

You will work closely with Manufacturing, QC, and other Quality functions to identify, elevate, and resolve issues in real

Qualifications

• Bachelor’s degree in science or engineering, or equivalent experience.
• 0-3+ years of relevant experience in a GMP-regulated biopharmaceutical environment.
• Working knowledge of GMP regulations (US, EU, ROW), GDP, 21 CFR, USP, and applicable standards.
• Strong attention to detail and effective written and verbal communication skills.
• Ability to work independently and cross functionally on common goals.

Responsibilities

• Provide on-floor QA support during GMP manufacturing to ensure compliance with procedures and cGMP standards.
• Participate in the QA walkthrough program to identify potential gaps/issues in the GMP facility.
• Escalate quality issues promptly and support real-time troubleshooting.
• Support batch disposition through compilation of required documentation.
• Review batch records, logbooks, and GMP documentation for completeness and.

Skills

On-floor QA

cGMP knowledge

Documentation review

Cross-functional collaboration

Education

Bachelor’s degree in science or engineering

Job description

Abzena in the United States is seeking an Associate I, Quality Operations to provide day-to-day QA oversight and documentation review to support GMP manufacturing of intermediates and drug substances. The role ensures production activities are executed in compliance with cGMP requirements through on-floor QA presence, batch record review, and support of batch disposition.

You will work closely with Manufacturing, QC, and other Quality functions to identify, elevate, and resolve issues in real