Quality Control Analyst I

The Position

As a Quality Control Analyst I in our Bioassay US Testing Group, you will play an essential role in advancing clinical and commercial therapeutics. Our team is committed to high-quality science and collaboration, delivering critical testing that directly impacts patient lives. This role offers an engaging, hands-on laboratory environment with continuous opportunities to develop your technical and analytical expertise in biopharmaceuticals.

The Opportunity

• Perform biochemical and immunological cell-based and non-cell-based assays to support clinical and commercial products.
• Support critical operations including process development, product characterization, stability studies, in-process testing, and lot release testing within a cGMP environment.
• Review and release assay data across both electronic and paper-based formats while maintaining high compliance standards.
• Prepare laboratory reagents, monitor assay performance, and clearly present quality results to cross-functional teams.
• Uphold data integrity and quality standards by applying Good Documentation Practices (GDP) and ALCOA++ principles.
• Maintain high laboratory standards by actively participating in Environmental Health and Safety (EHS) practices, 5S workplace organization, and routine equipment upkeep.
• Leverage quality systems and laboratory informatics, including LIMS, electronic lab notebooks (ELN), and document management platforms.

Who you are

• Hold a Bachelor's degree in Biological Sciences or a related field with 1-2 years of relevant experience in a Quality Control or GxP laboratory environment.
• Bring proven, hands-on laboratory experience performing cell-based and non-cell-based assays.
• Possess strong working knowledge of cGMP standards and hands-on experience with aseptic cell culture techniques.
• Are proactive, detail-oriented, and able to work both independently and collaboratively across multidisciplinary teams.
• Demonstrate clear written and verbal communication skills well-suited for a fast-paced, quality-focused setting.

Preferred

• Hands-on experience working with industry-standard GxP electronic systems, such as SoftMax Pro, LIMS, and Veeva QMS.