Quality Systems Specialist I, Contract (26305-T-682-QC)

WHO WE ARE Arsenal Biosciences Inc. is a clinical-stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We seek a talented and experienced Quality Systems Specialist I to work onsite based in our Hayward office.    ArsenalBio’s mission and purpose are very clear: defeat cancer. With our programmable and computationally driven approach, our team is engineering medicines to attack cancer’s inherent multifaceted nature and overcome the challenges of addressing solid tumors with cell therapy.   Driven by a collective of diverse experts across multi-scientific disciplines and clinical and manufacturing expertise, we are united in our purpose to develop the optimal medicines for improving patients’ lives.   This means you’ll have the opportunity to work with the best talent in the field of cell therapy and be part of ONE TEAM, which advances therapies for patients who need it most.   We are seeking a talented and motivated Quality Systems Specialist I to join the ArsenalBio Technical Operations team. The individual will provide support in helping maintain the Quality Management System. The individual will support ArsenalBio in generating and maintaining quality documents and records in accordance with regulatory requirements. The individual will interact cross-functionally across the organization to enable the success of ArsenalBio. Duties and responsibilities may be adjusted to meet the specific needs of the organization. The position will report to Sr. Quality Systems Specialist II.  

WHAT YOU’LL DO

• Provide support in the management of Quality Management System
• Create, issue, and reconcile production batch records, labels, and logbooks
• Organize, maintain, and ensure proper storage of physical and electronic quality records
• Prepare and manage offsite storage of controlled records, including review, scanning, and scheduling transfer
• Provide administrative support for Quality Systems, including meeting coordination, meeting minutes, action items tracking, scanning and filing records
• Maintain the document room, handle supplies and oversee general housekeeping activities
• Assist in audit preparation, tracking audit responses, and Corrective Actions
• Process documents, ensuring accurate data entry into databases and compliance checks
• Track, report, and analyze quality metrics, as required
• Identify process improvements and contribute to continuous improvement initiatives
• Provide Veeva support as needed, such as document formatting, profile maintenance,  and tracking periodic review
• Perform additional tasks as assigned
 

WHO YOU ARE

• Bachelor’s degree with 0-2 years of experience in the biotech/pharmaceutical industry or quality experience, preferably in a GxP environment
• Strong written, verbal, and technical skills including proficiency in MS Office Suite (Word, Excel, Powerpoint)
• Excellent organizational skills with the ability to multitask and prioritize work of varying complexity simultaneously
• Ability to collaboratively work cross-functionally
• Knowledge of Quality, document control cGMP/ICH/FDA regulations and GMP requirements for cell and gene therapy Is preferred
• Experience with Veeva Vault Quality Management System (QMS), electronic Document Management Systems (eDMS) and Learning Management Systems (LMS) and technical writing is a plus
 

BENEFITS AND PAY Our people-first culture cultivates a deep respect for humanity, not only in those we serve but also in one another. We take pride in being part of a company that values and celebrates diversity—in experiences, ideas, and interests. We are empowered in an environment that embraces unity and inclusivity, fostering a sense of belonging and mutual respect.   We provide powerful tools to empower our employees to take charge of their career paths and reach their full potential. At ArsenalBio, we believe in investing in our employees' well-being—both professionally and personally—because our people are our most valuable asset. Our essential team members bring exceptional expertise in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software, and other fields to turn the possibilities of tomorrow into the realities of today.   We are committed to hiring the best talent from diverse backgrounds. A diverse workforce engenders richness of thought, creativity and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients.   We are an equal opportunity employer and deeply value d