Senior Quality Assurance Specialist II (24119-R-682-QA)

WHO WE ARE

Arsenal Biosciences Inc. is a clinical stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We are seeking a talented and experienced Senior Quality Assurance II to work onsite based in our Hayward office. 

ArsenalBio’s mission and purpose is very clear: defeat cancer. With our programmable and computationally driven approach, our team is engineering medicines with the goal 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 as well as 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 advancing therapies for patients who need it most.

We are seeking a talented and motivated Quality Assurance Contractor to join the ArsenalBio Technical Operations team. The individual in this role will provide on-site support for ArsenalBio’s Quality and Manufacturing teams at our Hayward and San Francisco sites.  Primary responsibilities will be to support and oversee clinical manufacturing operations, as well as support Quality Operations and develop/refine processes. 

• Ownership and/or QA oversight of records in the Quality system, including Change Controls, Deviations and CAPAs, among others.
• Author and/or revise documents, including SOPs, forms, specifications and work instructions, among other documents.
• Provide on-site (in plant) QA support for clinical manufacturing operations at Arsenal’s Hayward and San Francisco facilities, including:

• As required, participate in standing Quality forums, including Deviation triage, Change Control Review Board, Material Review Board among others.
• Improve and mature Arsenal Quality systems and processes.

• A High School Diploma with 8+ years of QA experience or a BA/BS in a relevant scientific field or discipline with 6+ years QA experience.
• Strong background in Manufacturing and/or Quality in a CGMP environment with knowledge of CGMP/ICH/FDA/EMA regulations.
• Direct experience writing and reviewing SOPs and other Quality documents.
• Direct experience with Quality investigations, assessments, reviews and/or evaluations of Quality records (deviations, CAPAs, change control, etc.).
• Direct experience with root cause investigations and CAPA determination.
• Direct experience reviewing primary documentation, including manufacturing records, including batch records and forms.

BENEFITS AND PAY

Our people-first culture fosters a deep appreciation for humanity, both in the people we endeavor to serve as well as each other. We are proud to work for a company that is driven by diversity in experiences, ideas and interests, and one that empowers us in an environment that embraces both unity and inclusivity.

We have robust tools to help employees take control of their career paths and grow into their best selves. ArsenalBio believes in investing in the well-being of our employees - both at work and at home, as our people are our greatest asset. They bring scientific talents in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software and other fields to make the future happen now.

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 value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

The estimated base salary for the preferred primary location of the San Francisco Bay area ranges from $127,300 – $156,000. Salary ranges for other locations may vary.  Base pay offered may vary based on job related knowledge, experience, education, and location.  In addition to these factors, we believe in the importance of pay equity and consider internal equity of our current employees as part of any final offer.

To all recruitment agencies: ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias, or ArsenalBio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.

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