At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s outstanding skills with those of people from all over the globe.

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 in Durham, NC, which is situated in Research Triangle Park; the leading center of innovation in the Southeast!

In this role as Quality Advisor, you will support the North Carolina Manufacturing Facility (NCMF) in the manufacture of clinical products. As part of the Development Quality Assurance organization, you will ensure compliance and ongoing conformance to established quality assurance processes and procedures for manufacturing  inhalation products.

Main Responsibilities:

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

• Perform QA release of Drug Substance, Drug Product and Investigational Medicinal Product for clinical trials including performing quality review of release documentation for completeness and compliance with cGMPs as per regulatory requirements and internal procedures.
• Responsible for QA approval of documentation related to manufacturing equipment and facilities to ensure compliance, including maintenance, calibration, validation and change control.

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• Maintain internal controls over quality policies and procedures.
• Assist during Internal/External Inspections.
• Author or provide quality mentorship in the handling of nonconformance and CAPAs related to the medical device quality systems.
• Provide quality and technical support for the evaluation of change assessments for combination products and the device quality system.
• Support risk management (e.g. FMEA) and quality planning activities.

Minimum Requirements:

• 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.
• At least three (3) years of experience in quality assurance supporting the manufacture of drug products .
• 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

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

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

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Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.