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Quality Control Specialist- Operations

Местоположение Редвуд-Сити, Калифорния, США Идентификатор вакансии R-140994 Дата публикации 06/15/2022

Would you like to use your experience as a Quality professional in a GMP, fast-paced team environment company that follows science and turns ideas into life-changing medicines? Are you searching for career growth and development in a Quality Control/Manufacturing environment with competitive salaries and benefits? If so, this position would be a great fit for you!

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.

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 exceptional 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 using a proprietary drug delivery platform and existing therapeutic agents administered in metered-dose inhalers (MDIs). Join us as a SHE Specialist at our Redwood City, CA site, the leading center of innovation in the West.

The QC Specialist will provide expert technical and analytical support to the Quality Control (QC) function including instrumentation and methodology troubleshooting, non-routine 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, support Environmental monitoring (EM) initiatives, and perform analytical laboratory testing.

What you will do:

  • Author and review documents relevant to the laboratory (i.e. SOPs, test methods, CAPAs, deviations, laboratory investigations, protocols, validation reports, risk assessments, trend reports, technical justifications)

  • Support and lead problem-solving activities for deviations and laboratory investigation, work requests with outside testing laboratories (i.e. perform technical data review, raise/troubleshoot issues that arise)

  • Support and understand areas (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.

Minimum Qualifications:

  • Bachelor's degree

  • Experience working in a Good Manufacturing Practice (GMP) environment

  • Proficient in problem solving, creativity, independent thought, and sound judgment

Preferred Qualifications

  • Bachelor's degree in a science-related field

  • Quality Assurance & Compliance Experience

  • Strong knowledge and understanding of analytical chemistry, Environmental Monitoring, laboratory instrumentation and GMP

  • Understanding of the QC function, and its role and importance to the business.

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 are developing new ways to work, cutting-edge methods, and bringing unexpected teams together. Come and join our journey!

Next Steps – Apply Today!

Are you ready to bring new insights and fresh thinking to the table? Curious to know more, then 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. Know someone who would be an excellent 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.

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