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QA Associate I/II, Operations - Shift B

Abzena Inc. · Bristol, PA

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With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Associate I, Quality Operations provides 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. The position works closely with Manufacturing, QC, and other Quality functions to identify, escalate, and resolve issues in real time.