Welcome to Coppell, TX, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities, it’s important to us that you bring your full self to work every day. The Lokelma ® Supply Site (LSS) has an open concept office space designed to provide a pleasant office environment to support varying work styles and collaboration needs. LSS has an on-site café with a selection of snacks and refrigerated grab-and-go items for purchase. Additionally, the site offers a food delivery service through Foodsby, allowing employees to purchase food from a variety of local restaurants to be delivered to the site, which currently includes a discounted price for LSS employees. Electric car charging stations are also available for use.
As a Quality Assurance Release Associate, your responsibilities will include advancing quality issues to Site Quality Leadership Team, reviewing drug substance batch documentation for compliance, initiating investigations on behalf of quality, maintaining and revising QA SOPs, and supporting the complaint process by conducting batch record reviews. You will also serve as the primary quality contact in PET SOPs and Forms and maintain quality metrics to support batch disposition business process owner or management reviews.
Essential Skills/Experience:
- A minimum of five years of experience as a Quality Assurance professional in the pharmaceutical manufacturing industry
- Proficiency in verbal and written communication in English
- Knowledge of cGMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies
- Experience with regulatory agency interactions
- Familiarity with Microsoft Word, Excel, and PowerPoint
Desirable:
- Bachelor’s degree in a science or engineering curriculum
When we put unexpected teams in the same room, we ignite 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 the entire shift onsite, 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 progressive world.
Why AstraZeneca?
At AstraZeneca, we take Quality seriously. Our work is important and valued. We are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. We are a team of motivated people who are proactive, science-based, and solutions-oriented. We work cross-functionally, across sites and regionally, sharing expertise and offering support to others. Our focus is on scaling and introducing new technologies, using models to predict and proactively manage risk. Join us as we continue our Lean journey towards constant growth and innovation.
Ready to make a difference? Apply now to join our team and help us ensure that our pipeline becomes a reality!
Date Posted
24-Jun-2024
Closing Date
14-Jul-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.