Do you have experience in Quality and enjoy supporting a Quality Assurance organization in a company that follows the science? If so, the Sr. Quality Assurance Specialist role at AstraZeneca is the right fit for you!

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

Develop your expertise by being both challenged and supported to apply a ‘modern’ Quality mindset. It means taking accountability and making brave decisions. Whether that’s reimagining the best way to respond to procedures and regulations, or pushing back when there’s disagreement.

We partner and problem-solve with product and process experts to ensure we perform with excellence across the Quality network.

What we do is important and valued – we make a real-life difference to patients. Here we have built an unrivaled reputation in Quality, through our ‘Total Quality’ culture that takes us beyond pure compliance.

AstraZeneca Durham has expanded and strengthened its respiratory products portfolio, delivering approvals and launches for multiple global inhalation products, with a robust pipeline in development. Our mission, through dedication to creating a culture of inclusion and teamwork, is to develop innovative therapeutics for respiratory diseases and conditions including asthma and COPD. This site is responsible for the product, device, process, and analytical development of new inhalation products in the AZ portfolio. The site also manufactures and packages clinical supplies to meet clinical trial demands. Join us as a Sr. Quality Assurance Specialist, which is situated in Research Triangle Park; the leading center of innovation in the Southeast!

In this role as a Sr. Quality Assurance Specialist, you will support the Quality Assurance organization with compliance and ongoing conformance to established quality assurance processes and procedures for developing inhalation products.

What you will do:

• Provide QA input into internal manufacturing activities for Drug Substance and Drug Product, including issue batch documentation and labels for GMP manufacture/packaging, supporting on-the-floor manufacturing activities, supporting manufacturing and packaging deviations and investigations

• Responsible for QA release of Drug Substance, Drug Product, and Investigational Medicinal Product for clinical trials including performing a quality review of release documentation for completeness and compliance with cGMPs as per regulatory requirements and internal procedures.

• Assist during Internal/External Inspections.

• Manage projects related to compliance of the quality system, development of new procedures and controls, and maintenance of established programs.

• Provide quality and technical support for the evaluation of change assessments for combination products and the device quality system.

Minimum Qualifications

• Bachelor’s 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 studies.

• Demonstrated knowledge of Quality Assurance activities and ICH and FDA/EU GxP regulations as they relate to clinical trials, product development, manufacturing, and technology transfer.

• Outstanding interpersonal, problem solving, and written/verbal communication skills.

Preferred Qualifications:

• Minimum of three (3) years of experience in quality assurance is preferred

• Excellent team working and networking skills to encourage team effectiveness; ability to lead and inspire colleagues.

• Demonstrates independent judgment 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.

Why AstraZeneca

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth, and development.

So, what’s next

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

Find out more on Social Media:

• LinkedIn https://www.linkedin.com/company/1603/

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• Instagram https://www.instagram.com/astrazeneca/?hl=en

• About Operations https://www.youtube.com/watch?v=gak5Ham8oUw