Senior Qa Specialist - Quality Systems & Risk

As a Senior QA Specialist, you will interpret internal quality standards and external regulatory requirements for the manufacturing of a biologic combination product. You will lead, support, and provide guidance to other functional teams in Operations, QC, and Quality in various areas such as Deviation, CAPA, Effectiveness Checks, Product Complaints, Supplier initiated changes, Change Controls, Quality Risk Management, OOS (Out of Specification), and EMIRs (Events of Major Incidents or Recalls).
In addition to these core responsibilities, you will act as a local process champion and regional process champion for relevant Quality business processes. This entails ensuring compliance with established quality standards and driving continuous improvement initiatives within these processes. You will also serve as a backup to management, providing support and stepping in when necessary.
As a leader and mentor, you will guide and mentor QA specialists, fostering their professional development and ensuring their adherence to quality standards. You will also have above-site responsibilities for specific business processes and work streams, ensuring their effective implementation and compliance with regulatory requirements.
Furthermore, you will facilitate and spearhead work stream activities such as Material Review Board (MRB) and Change Review Board (CRB), as well as records management to ensure timely quality record management.
Essential Skills/Experience:
- Bachelor of Science in Biology, Chemistry, Engineering or related fields is required, unless significant relevant professional experience can be substituted.
- Minimum of 6 years of experience in the Biopharmaceutical/pharmaceutical industry
- Minimum of 4 years of experience in Quality Assurance, Quality Control or Validation
Desirable Skills/Experience:
- A graduate degree is desirable.
- Project management experience
- Six Sigma Certification (Yellow Belt and/or Green Belt)
- Working knowledge of Quality Information and Documentation Systems.
- Experience in regulatory inspections (FDA, EMA, MHRA, PDMA, etc)
- Experience reviewing and approving validation life cycle documentation.
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 five days per week from the facility. 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 high-reaching 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 draw learnings from others to develop and understand what it takes to drive our modern mindset forward. Here you'll feel empowered to step up, follow the science and evidence to make decisions that put patients first. We are a team of bold people, who want to go far and we're all here to achieve. It's what drives us to be proactive and solutions-focused. At every stage of production, we step up and take accountability to deliver, each of us feeling responsible for the outcomes.
Ready to make a difference? Apply today and join our team in Operations!
Date Posted
29-Feb-2024
Closing Date
11-Apr-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.