QA Associate Jobs at Abzena | BS Life Science Graduates Apply
Abzena, a global leader in biologics and bioconjugates development, is hiring QA Associate I/II for its Quality Operations team. This role offers life science professionals the opportunity to contribute to high-quality biologics manufacturing while ensuring compliance with current Good Manufacturing Practice (cGMP) and regulatory standards. If you are passionate about quality assurance and advancing life-saving treatments, this is your chance to join a trusted CDMO partner dedicated to innovation and patient care.
- Job Position: Quality Assurance (QA) Associate I/II – Operations
- Salary: $60,000 – $80,000 a year
About the Company
Abzena is a trusted Contract Development and Manufacturing Organization (CDMO) with extensive expertise in biologics and bioconjugates. From early discovery to commercial manufacturing, Abzena delivers integrated solutions to accelerate timelines and bring vital medicines to patients safely and efficiently. With a strong commitment to quality, innovation, and regulatory compliance, Abzena stands as more than just a CDMO—it is a dedicated partner from concept to patient.
Education:
Bachelor’s degree (B.S.) in Life Sciences.
Experience:
- 2+ years of experience in a GMP-regulated biopharmaceutical facility.
- 1–3 years of experience in Quality Assurance-related functions.
- Strong knowledge of GMP regulations (US, EU, ROW), cGMP, 21 CFR, USP, and other applicable standards.
- Experience in manufacturing oversight, batch record review, and compliance documentation.
- Ability to work in a fast-paced, cross-functional environment.
Job Description:
The QA Associate I/II in Quality Operations will play a crucial role in ensuring compliance and promoting a culture of quality throughout manufacturing processes. This position involves hands-on collaboration, quality oversight, and ensuring adherence to cGMP and GxP standards while supporting the production of life-saving biologics.
QA Associate Key Responsibilities:
- Provide QA collaboration and oversight to ensure compliance with good documentation practices and GxP standards.
- Work on the floor during production and make quality decisions in line with procedures and regulations.
- Perform raw material sampling and release utilities as needed by the QA Raw Material team.
- Conduct area walkthroughs of manufacturing and Quality Control areas.
- Author and review deviations, SOPs, CAPAs, and change controls.
- Conduct batch record reviews for buffer/media, upstream, and downstream manufacturing processes.
- Disposition buffer/media solutions manufactured at Abzena.
- Support cross-functional departments to meet business needs while complying with Abzena’s policies and regulatory standards.
QA Associate Physical Requirements:
- Ability to stand, sit, lift, move objects, and perform various physical activities
- Visual abilities for detailed tasks
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