Quality Systems Specialist II

Are you ready to make a significant impact in the pharmaceutical industry? As a Quality Systems Specialist II, you will play an essential role in supporting quality system activities that are vital to our site processes. Your focus will be on documentation and training process support, ensuring that our operations align with best practices and deliver excellence every time. Join us in this dynamic role where you'll collaborate with subject matter experts, improve processes, and contribute to the continuous improvement of our quality systems.

Accountabilities

In this role, you will be responsible for managing documentation issuance, including procedures, test methods, specifications, validations, and study reports. You'll ensure data entry and archival processes support documentation and training activities effectively. Collaborating with cross-functional departments, you'll facilitate timely implementation of document change requests. As an EDMS super user, you'll assist and troubleshoot customer issues while ensuring document accuracy and completeness. Additionally, you'll support audits, update training curricula, and interact with various departments to prioritize documentation needs. Your ability to multitask across multiple functional quality system areas will be key to your success.

Essential Skills/Experience

- BA/BS degree or equivalent combination of education and professional experience within the pharmaceutical industry (preferably Cell Therapy or Biologics).
- Strong verbal and written communication skills.
- Strong organizational skills, and attention to detail.
- Strong analytical and problem-solving skills.
- Ability to function well in a high-paced environment.
- Proficient with Microsoft Office Suite or related software.
- Knowledge of GMP SOPs and quality system processes.
- Working knowledge of global GxP regulations.
- Ability to communicate and work independently with scientific/technical personnel at all levels.
- Experience in pharmaceutical or bio-pharmaceutical field.

At AstraZeneca, we are driven by a commitment to improve patients' healthcare and quality of life. Our work in Quality is not just about compliance; it's about adding real value throughout the lifecycle of our products. We are constantly innovating and trialling new models and technologies to enhance reliability and excellence in our processes. Here, you'll find an inclusive community where each voice matters, empowering you to make decisions that put patients first. With a focus on growth and innovation, AstraZeneca offers endless opportunities to develop a fulfilling career while making a real-life difference.

Ready to take on this exciting challenge? Apply now and become part of a team that is dedicated to delivering excellence in every batch we certify!

The annual base pay (or hourly rate of compensation) for this position ranges from$79,879 to $119,818 . Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. 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 (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). 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. 

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.