QA Operations Associate (GMP) – Biopharma

Abzena Inc.; Bristol Township (Bucks County); On-site; USD 55,000 - 75,000; Full time

Job summary

Abzena is seeking an Associate I, Quality Operations in Bristol Township, PA to provide day-to-day QA oversight for GMP manufacturing of intermediates and drug substances. The role ensures production activities comply with cGMP through on-floor presence, batch record review, and support of batch disposition.

The successful candidate will collaborate with Manufacturing, QC, and other Quality functions to identify and resolve issues in real time, review SOPs and controlled documents, and

Qualifications

• Bachelor's degree in science or engineering or equivalent experience.
• 0-3+ years of GMP-regulated biopharma experience.
• Working knowledge of GMP regulations (US, EU, ROW), GDP, 21 CFR, USP.
• Strong attention to detail and written/verbal communication skills.
• Ability to work independently and with cross-functional teams.

Responsibilities

• Provide on-floor QA support during GMP manufacturing to ensure compliance with procedures and cGMP standards.
• Participate in QA walkthrough program to identify gaps 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.
• Review incoming material disposition packets and verify documentation.
• Perform QA review of SOPs, forms, protocols, and other controlled documents.
• Contribute to quality improvement, lean initiatives, and process efficiency projects.
• Assist across Quality functions including document control, training, audits, and systems.
• Communicate effectively with cross-functional teams and uphold quality standards and policies.

Skills

Attention to detail

Effective communication

Independent worker

Cross-functional collaboration

Education

Bachelor's degree in science or engineering

Tools

GMP documentation systems

CAPA tracking

Job description

Abzena is seeking an Associate I, Quality Operations in Bristol Township, PA to provide day-to-day QA oversight for GMP manufacturing of intermediates and drug substances. The role ensures production activities comply with cGMP through on-floor presence, batch record review, and support of batch disposition.

The successful candidate will collaborate with Manufacturing, QC, and other Quality functions to identify and resolve issues in real time, review SOPs and controlled documents, and