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Senior Quality Assurance Specialist

2 months ago

Durham, United States AstraZeneca Full time

As a Senior Quality Assurance Specialist, you will interpret external regulatory standards into appropriate quality standards, provide guidance to project teams, and ensure compliance with AstraZeneca and Regulatory requirements. You will lead continuous quality improvement efforts in line with GMP regulations, support QA release of Drug Substance, Drug Product and Investigational Medicinal Product for clinical trials, and maintain internal controls over quality policies and procedures. You will also manage projects related to compliance of the quality system, development of new procedures and controls, and maintenance of established programs.

Essential Skills/Experience:
- Bachelors Degree, preferably in Life Sciences.
- Minimum of five (5) years of experience working in the pharmaceutical and/or biotechnology field with a focus on GMP environment.
- At least three (3) years of experience in quality assurance.
- Demonstrated knowledge of Quality Assurance activities and FDA/EU GxP regulations.
- Outstanding interpersonal, problem solving, and written/verbal communication skills.

Desireable Skills/Experience:
- Excellent team working and networking skills.
- Demonstrates independent judgement and uses risk management in complex situations.
- Capable of making decisions, acting courageously and communicating with conviction and inspiration.
- A good communicator with experience of interacting effectively across interfaces collaborating internally.
- Builds excellent relationships both internally and with external suppliers or service providers.
- Experience relating to clinical trials, product development, manufacturing, technology transfer, validation and qualification processes.

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 our 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 ambitious world.

Why AstraZeneca?
With constant new products and launches, there's never been a better time to join our Operations team at AstraZeneca. Here you can feel a strong connection to the patient. It's what drives us every day. We are united behind one mission: finding the best solution to put our patients first. Play a critical role in making this happen, delivering our innovative medicines all the way until they reach our patients. If you are driven, take smart risks and are able to act quickly, then this is the place for you.

Ready to make a difference? Apply now to join our team

Date Posted

28-Jun-2024

Closing Date

18-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.