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QA Associate II, OperationsAbzena • United States
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QA Associate II, Operations

Abzena
  • US
    United States
  • US
    United States
Jetzt Bewerben

Über

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.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
  • United States

Sprachkenntnisse

  • English
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