QA Specialist (Specialist / Senior Specialist / Principal Specialist)

Join us as a QA Specialist, where you'll handle QA activities that directly support the execution of the process within the Process Execution Team (PET) and in assigned areas outside of the PETs. This includes batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions.

Accountabilities:
Our QA Specialist, maintain a high level of understanding of relevant production processes and quality systems. You'll perform the QA review and approval of GMP documentation related to processing equipment and facility. You'll collaborate with other Quality professionals across the organization to ensure consistent application and execution of key quality systems. You'll complete QA processes including batch record review, sampling and inspection of incoming materials, product disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives. Are you ready to assume these meaningful responsibilities?

WORK SCHEDULE: 2nd Shift - 4 days/wk, 10 hrs/day from Tuesday through Friday.
Essential Skills/Experience:
QA Specialist:
- High School (diploma/GED) and 2+ years of experience in GMP environment or - Bachelor's degree in relevant field of study with 0-1 years of experience
- Strong ability and motivation to learn
Sr. QA Specialist:
- Five (5) years experience in the pharmaceutical industry and/or FDA experience with at least three (3) years in Quality Assurance/Compliance.
Principal QA Specialist:
- Seven (7) years experience in the pharmaceutical industry and/or FDA experience with at least five years in Quality Assurance/Compliance.

Desirable Skills/Experience:
QA Specialist:
- BS degree in Technical Field of Study w/3+ years working in a highly regulated industry.
Sr. QA Specialist
- 7+ years in QA/Regulatory Compliance in the pharmaceutical industry.

When we put unexpected teams in the same room, we enable creative thinking with the power to encourage 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, the entire shift 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 outstanding and bold world.

Why AstraZeneca?
With constant new products and launches, there's never been a better time to join Supply Chain at AstraZeneca and craft our future with a big contribution to life-changing medicines. Our resilience helps us to succeed as we innovate and evolve. We are a diverse, multigenerational team of authorities connected across the globe. We interpret the science, connecting it with the business need to apply manufacturing excellence. If you are tenacious, take sensible risks and are able to act quickly, then this is the place for you!

Ready to make a big impact? Join us at AstraZeneca where our contribution to life-changing medicines is why people have been here for decades. We do it for the patients. Apply now!

Date Posted
28-Mar-2024
Closing Date
24-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.
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