QA Specialist (NIGHTS 8pm-4am)- Redwood City, CA
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.
What you'll do:
You will be responsible for QA activities that directly support execution of the process both within the Process Execution Team (PET), and in assigned areas outside of the PETS. These activities may include but are not limited to: batch release, change control, and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions.
Perform the QA review and approval of the following GMP documentation as it relates to the processing equipment
Batch Records and associated documentation
Product and Component Release transactions in SAP
Quality Investigations (Deviations, Product Complaints)
Validation Plans, Protocols and Reports
Collaborates with and influences other Quality professionals across the organization to ensure consistent application.
Executes QA processes including batch record review, product and material disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives
Works with applicable site support groups on projects (capital and non-capital) that impact the PET/assigned area, and proactively ensures GMP compliance during the planning, execution and closeout phases of these projects
Collaborates with and influences other PET/assigned area members to facilitate process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices
Collaborates in data analysis and report creation on quality metrics and key performance indicators
Bachelors degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering or any Bachelors degree with 3 years experience in pharmaceutical industry in roles covered by GMP oversight.
Excellent oral and written communication skills
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!
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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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 authorisation and employment eligibility verification requirements.