Abzena

QA Associate II

Abzena  •  Bristol, PA (Onsite)  •  3 months ago
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Job Description

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 II, 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.

Responsibilities

  • Provide on‑floor QA support during GMP manufacturing to ensure compliance with procedures and cGMP standards.
  • Monitor manufacturing operations and facility conditions to maintain a compliant environment.
  • Escalate quality issues promptly and support real‑time troubleshooting.
  • Review batch records, logbooks, and GMP documentation for completeness and accuracy to support timely disposition.
  • Review incoming material disposition packets and verify documentation completeness.
  • Support data review, trending, and identification of quality risks.
  • 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.
  • 2–5 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, manage multiple priorities, and perform under pressure.
FLSA: Exempt     Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.     
Abzena

About Abzena

Abzena is the leading end-to-end bioconjugate, ADC, and complex biologics CDMO + CRO. From discovery through commercial launch, we support customers with fully integrated programs or individual services designed to de-risk and streamline the development of new treatments for patients in need. With the ability to tailor its strategy and customer experience to each project, Abzena develops and implements innovative solutions that enable biotech and biopharma companies to realize the full potential of their molecule and move medicines forward faster. The company has research, development, and cGMP facilities across locations in San Diego, CA, Bristol, PA, and Cambridge, UK.

Industry
Chemicals & Materials
Company Size
201-500 employees
Headquarters
San Diego, California
Year Founded
2001
Website
abzena.com
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