On-Floor GMP QA Associate – Biopharma Manufacturing

Abzena; Bristol Township (Bucks County); On-site; USD 60,000 - 75,000; Full time

Job summary

Abzena, headquartered in Bristol Township, PA, seeks an Associate I, Quality Operations to provide day-to-day QA oversight and documentation review in support of GMP manufacturing of intermediates and drug substances.

The role ensures production activities comply with cGMP through on-floor QA presence, batch record review, and support of batch disposition, working closely with Manufacturing, QC and other Quality functions to identify, elevate, and resolve issues in real time.

Qualifications

• Bachelor's degree in science or engineering, or equivalent experience.
• 0-3+ years of relevant GMP-regulated biopharmaceutical experience.
• 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.
• Review incoming material disposition packets and verify documentation completeness.
• 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 company quality standards and policies.

Skills

Attention to detail

Written and verbal communication

Cross-functional collaboration

Independent work

Education

Bachelor's degree in science or engineering

Job description

Abzena, headquartered in Bristol Township, PA, seeks an Associate I, Quality Operations to provide day-to-day QA oversight and documentation review in support of GMP manufacturing of intermediates and drug substances.

The role ensures production activities comply with cGMP through on-floor QA presence, batch record review, and support of batch disposition, working closely with Manufacturing, QC and other Quality functions to identify, elevate, and resolve issues in real time.