Quality System Documentation Specialist

Position Summary

The Quality System Documentation Specialist is responsible for performing activities that directly support execution of site processes. The incumbent will support quality systems, with a focus on documentation and training process support. We are seeking a highly motivated individual to join us and assist with document processing and other duties related to the processing and archival of documentation. The successful candidate is proficient in communication (written and verbal), can multi-task, is a time-line focused and flexible in their work schedule. You will be expected to provide support for both the Santa Monica, CA and Tarzana, CA sites as needed. 

Essential Functions and Responsibilities

• Responsible for uploading documentation into our EDM system.

• Responsible for overall documentation issuance (such as, but not limited to procedures, test methods, specifications validations, and study reports); data entry and archival processes to support documentation and training activities.

• Collaborates with cross-functional departments, to ensure timely implementation of document change requests.

• Ensures accuracy by reviewing documents for completeness, proper authorization, and impact to other quality systems.

• Support audits (internal, external)

• Update and create training curriculum revisions as needed

• Perform other duties and special projects as assigned to support the doc control team.

• No supervisory responsibilities.

Education and Required Skills/Abilities

• High School diploma with up to 4 years of relevant experience is required. Relevant academic experience, coursework, or internships are a plus.

• Strong verbal and written communication skills.

• Strong organizational skills, and attention to detail.

• Ability to function well in a high-paced environment.

• Proficient with Microsoft Office Suite or related software.

• A working understanding of global GxP regulations, along with familiarity in GMP SOPs and quality system processes, is preferred.

#LI-onsite #CellTherapy

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and daring world.

Ready to make a difference? Apply now and join us on this exciting journey!

The annual base pay for this position ranges from $65,556.80 - $98,335.20. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

02-Apr-2026

Closing Date

08-Apr-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.