As a Sr. Specialist QA, you will be a part of the Quality Systems & Compliance team based in Thousand Oaks, California. As the Business Process Owner, you will have the overall responsibility to develop, implement and sustain the Atara Quality Audit Program ensuring compliance with internal requirements and external GMP regulations. Responsible for a high level of understanding of the standards and principles of auditing and the auditing techniques of examining, questioning, evaluating, and reporting to determine a quality system's adequacy and deficiencies. Partner with business functions to ensure the successful implementation of the Audit Program. This role will require the strategic capability in the form of program development and ownership (including policies, procedures, leading governance, and quality performance monitoring efforts, etc.). In addition to serving as a subject matter expert in these areas, you will be responsible for maintaining strong, collaborative partnerships with cross-functional and cross-site team members and to create a successful program which would include but not be limited to, Internal, External (Partner), Supplier, Regulatory Body, and Clinical Audits.
Work Location Thousand Oaks, CA
Reports to Director, Quality Systems & Compliance
Travel Travel required (up to 10%)
We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.
We’re proud of our team of 425+ Atarians co-located by design in 4 different locations including South San Francisco (corporate headquarters), Thousand Oaks (R&D and manufacturing headquarters), Zug, Switzerland (european headquarters) and a R&D site in the Denver, Colorado area. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility.
Our mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork, and a commitment to excellence.”
Our vision - “T-Cell Immunotherapy for every patient, any time.”
Atara offers a competitive benefits packages that includes medical/dental/vision benefits, life and disability, retirement and stock program, as well as a generous paid time off and wellness plan that supports the well-being of our staff. Visit www.atarabio.com/careers to learn more.
Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual’s association with a member of a protected group or connection to an organization or group related to a protected group.
We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States.