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 outstanding skills with those of people from all over the globe.

In 2013, AstraZeneca acquired Pearl to expand and strengthen its respiratory products portfolio, We have made strides in bringing therapies to asthma patients. Our mission and vision are to develop differentiated therapeutics for widely prevalent respiratory disease conditions, including chronic obstructive pulmonary disease (COPD), by utilizing a proprietary drug delivery platform and existing therapeutic agents administered in metered-dose inhalers (MDIs). Join us as a Quality Analyst at our Redwood City, CA site, the top tier center of innovation in the West. We are dedicated to crafting a culture of inclusion and teamwork.

Why Join Quality?

In Quality, our work is meaningful and valued. An outstanding 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 perfection 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 aim to accelerate growth and make people’s lives better – then this is the place for you!

What you'll do:

To provide expert technical and analytical support to the Quality Control (QC) function through routine and non-routine analytical testing, instrument and methodology troubleshooting, data analysis, and the evaluation and exploitation of new technology. The individual will focus on leading projects at the QC department and Quality site level, work with the AstraZeneca project management organization (PMO) framework to communicate and deliver project results, lead high performing laboratory (HPL) initiatives, and perform analytical laboratory testing. The individual should be qualified to an undergraduate level or equivalent in a scientific discipline, with experience working in a Good Manufacturing Practice (GMP) environment. Must have strong knowledge and understanding of analytical chemistry, laboratory instrumentation, GMP, and AstraZeneca values & behaviors. Must have strong understanding of the QC function, and its role and importance to the business

• Act as a leader in the laboratory through display of leadership capabilities
• Serve as a main contact for issues and aid/direct troubleshooting activities when appropriate
• Train and mentor analysts of various levels on QC processes, test methods, software, and instruments
• Lead and support step change improvements to processes at the QC function and Quality department level
• Author, review, and approve documents relevant to the laboratory (i.e. SOPs, test methods, CAPAs, deviations, laboratory investigations, protocols, validation reports, risk assessments, trend reports, technical justifications)
• Support preparation of site-wide reports (i.e. quality management review, annual product quality review)
• Support and lead problem-solving activities for deviations and laboratory investigations
• Perform routine and non-routine analytical testing for raw materials, active pharmaceutical ingredients (APIs), intermediate drug products, purified water (PW), and stability samples
• Support and manage scheduling of QC laboratory testing and activities
• Track and report key performance indicators (KPIs) and metrics for QC
• Represent the QC function during internal and external audits
• Support and lead work requests with outside testing laboratories (i.e. schedule analytical support, perform technical data review, escalate/troubleshoot issues that arise
• Serve as a SME for areas relevant to the laboratory (e.g. sample receipt, sample testing, data review, instrumentation, software systems)
• Ensure safety is a priority by maintaining a safe work environment and immediately reporting unsafe conditions

Essential for the role:

• Bachelor of science degree, preferably in chemistry or microbiology
• 5 years relevant industry or laboratory experience required
• Experience with electronic laboratory notebooks, LIMS, Empower, SAP is preferred
• Experience in commercial operations is preferred
• Experience communicating with outside test laboratories (OTL)

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.

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