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QA Specialist II/III

AstraZeneca
Gaithersburg, United Statesfull_timeVerifiedPosted 31 Jul 2024

About the role

Introduction to Role:

Join us at AstraZeneca as a QA Specialist II/III in our Operations department. This non-supervisory role provides Quality Assurance support to an assigned area, including out-of-hours support. Be the voice of the patient and play a critical role as the eyes and ears of our patients. Monitor and sign off each batch as if the medicine were for your own family. Your contributions will add up to improving the quality of patients' healthcare and ultimately their quality of life.

Accountabilities:

As a QA Specialist II/III, you will be responsible for auditing internal and external utilizing a risk-based strategy. You will interpret and implement quality procedures, manage quality systems, and assist in facilitating regulatory compliance inspections. You will also be responsible for supporting other groups on completion of annual review and annual product reports. Some 2nd shift work may be required as per departmental need to support the manufacturing schedule.

Essential Skills/Experience: QA Specialist II

- B.S. in Biology, Chemistry, Engineering, or related fields or equivalent experience

- 3+ years relevant industry experience

- Experience in a Good Manufacturing Practice environment

- Strong interpersonal and communication skills including negotiation and facilitation

Experience: QA Specialist III

  • 5+ years relevant industry experience
  • B.S. in Biology, Chemistry, Engineering, or related fields or equivalent experience

- Preferred Technical and/or Manufacturing experience

- 2+ years quality experience

- Experience with all Quality record types and electronic Quality Management Systems

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 ambitious world.

At AstraZeneca, our work in Quality is important and valued. We are always innovating, trialing 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 ambitious people, who want to go far and we're all here to achieve.

Are you ready to make a difference? Apply today to join our team at AstraZeneca!

Date Posted

31-Jul-2024

Closing Date

08-Aug-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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Company

AstraZeneca

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