Quality Control Analyst I

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:

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

Who you are:

• You 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.
• You bring proven, hands-on laboratory experience performing cell-based and non-cell-based assays.
• You possess strong working knowledge of cGMP standards and hands-on experience with aseptic cell culture techniques.
• You are proactive, detail-oriented, and able to work both independently and collaboratively across multidisciplinary teams.
• You demonstrate clear written and verbal communication skills well-suited for a fast-paced, quality-focused setting.

Preferred:

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

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of California is $60,600 - $112,500 Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance. 

This position also qualifies for the benefits detailed at the link provided below.