Sr. Quality Assurance Specialist

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost 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 exceptional skills with those of people from all over the globe.
Join AstraZeneca and help us deliver life-changing medicines! Be among our employees who continue to make us an innovation-driven company that stands firmly among the leaders in BioPharmaceuticals.
Why Join Quality?
In Quality, our work is important and valued. An unrivalled forward-looking mindset, there's no better place to work at the forefront and learn how to add real value to a business throughout the lifecycle of our products - discovery, development and commercialization. As the voice of the patient, every batch we certify is a personal stamp of approval. Not something we take lightly, we are always innovating, trailing the latest models and technologies to improve reliability and excellence in our processes. A place to take Quality seriously - 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.
If you have the passion and the drive to accelerate growth and make people's lives better - then this is the place for you.
What you'll do:
The Senior Quality Assurance Specialist is a highly-visible, multi-functional, proactive site leader who is instrumental in maintaining AZ's Quality System and completing QA activities critical to delivering safe and timely supply of life-saving products to the market.
The role also achieves AZ's continuous improvement targets by lifting site compliance capabilities, simplifying Quality System business processes, representing the site on regional and global forums, continuous professional development, and driving GMP/Good Distribution Practice compliance performance forward.
This individual will execute routine QA responsibilities to support daily Operations / business targets by releasing products and resolving quality issues to ensure product quality, patient safety, site safety and site compliance.
The individual will actively develop and improve quality system processes, and quality performance at the local, regional, and global level.
Responsibilities:
Serving as local business process owner (BPO) for several AZ quality system elements (e.g. change control, document control, investigations, complaints, self-inspection, supplier quality management, etc.) to ensure their compliant and timely execution and continuous improvement.
• Ensuring site operations, equipment, processes and product comply with local, regional, and corporate procedures
• Maintaining controlled material status and distribution authorizations to ensure timely supply availability for distribution operations
• Collecting, analyzing and reporting site Quality System metrics for the site leadership team to ensure effective Quality System monitoring.
• Confirming technical quality and compliance for Validation, Facilities, Change Control, Investigations, Operations to ensure technically- and scientifically-sound, and GMP-compliant technical decisions and documentation.
• Ensuring robust risk management, problem solving, and root cause analyses at the site for investigations, change controls, risk assessments that subsequently ensures effective problem / risk management and reduction, and prevents problem recurrence.
• Continuously building up the site quality culture, driving continuous improvement, and building site cohesiveness / relationships.
May also be responsible for or involved in:
• Oversight of local GMP suppliers to ensure compliant supplier operations and change management.
• Local, corporate and external audits to ensure sufficient support and successful outcomes.
• Conducting product complaint investigations to assess distribution / distribution center factors contributing to reported complaints.
• Compiling, analyzing and reporting product-specific quality metrics data for annual product review / periodic quality review.
Experience:
Essential
BS Degree in Chemistry-, Microbiology-, or Engineering- or Science/Pharmaceutical field.
• 5-7 years' experience in pharmaceutical GMP commercial operations
• 3+ years direct experience in implementing or managing pharmaceutical / biologics GMP commercial quality management systems and processes
• Solid and broad understanding of key pharmaceutical GMP Quality Systems (e.g. deviation, CAPA, change control, document control)
• Strong technical / operations experience and aptitude
• Knowledge and practical experience of risk management, problem solving, root cause analysis, concepts and methodologies
• Practical knowledge of federal and international pharmaceutical regulations
• Data analysis, data verification, and problem-solving abilities.
Desirable
• 10+ years pharmaceutical / GMP commercial operations
• Professional Certifications in Compliance, Quality Management, Quality Engineering, or Lean Six Sigma.
• Knowledge of pharmaceutical distribution
• Proficient in Veeva Vault and SAP
• Proficient in MS Word, Excel, PowerPoint, Teams, SharePoint
• Effective project management skills and/or substantial exposure to project-based work structures.
Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
NOTE: This position will require you to be on site for 5 days a week
Date Posted
27-Nov-2023
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 (e.g. race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status). We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.