Abzena

CDMO for complex biologics and ADCs

Quality Assurance Associate 1/2 - Operations

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeBristol, PA, USANo salary listed

About the Job

Requirements

A bachelor's degree in science or engineering, or equivalent experience.
Zero to three or more years of relevant experience in a GMP-regulated biopharmaceutical environment.
Working knowledge of GMP regulations in the United States, European Union, and rest of world; Good Documentation Practices; 21 CFR; USP; and applicable standards.
Strong attention to detail and effective written and verbal communication skills.
Ability to work independently and cross-functionally toward common goals.
Ability to stand for one to two hours at a time and sit for two to three hours at a time.
Frequently lift or move objects weighing up to 30 pounds.
Visual abilities including near and far sight, color vision, peripheral vision, depth perception, and ability to focus.

Responsibilities

Provide on-floor Quality Assurance support during GMP manufacturing to ensure compliance with procedures and cGMP standards.
Participate in the QA walkthrough program to identify potential gaps or issues in the GMP facility.
Promptly escalate quality issues and support real-time troubleshooting.
Support batch disposition by compiling required documentation.
Review batch records, logbooks, and GMP documentation for completeness.
Review incoming material disposition packets and verify documentation completeness.
Perform QA review of standard operating procedures, 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 with cross-functional teams and uphold company quality standards and policies.

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.

Shift B: 4 x 10, Weds-Sat

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.

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.

Physical Requirements

Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.

Frequently lift and or move objects up to 30 pounds.

Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.

About the Company

Abzena

CDMO for complex biologics and ADCs

Abzena is a contract development and manufacturing organization (CDMO) that provides integrated services for complex biologics and bioconjugates, including antibody-drug conjugates, from discovery through GMP manufacturing for clinical trials and commercial supply. Its offerings cover antibody discovery, protein engineering, cell line development, process and analytical development, and cGMP manufacturing, often using its proprietary ThioBridge and Composite Human Antibody platforms. Abzena differentiates itself by delivering end-to-end development and manufacturing for complex biologics and by leveraging its proprietary technologies, with global facilities in the US and UK and a history of strategic acquisitions. Its goal is to help biotech and pharma programs progress efficiently from research to commercial supply by providing integrated services and potential licensing opportunities.

Company size: 201-500
Company stage: IPO
Headquarters: Babraham, United Kingdom
Founded: 2001

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