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QC Senior Manager at AstraZeneca

QC Senior Manager

AstraZeneca Gaithersburg, MD (On Site) Full-Time

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.Our Gaithersburg, Maryland facility builds life-changing medicines for people around the world. The modern, vibrant scientific campus employs more than 3000 guides in our field, and it is only a short drive from Washington, DC. It is filled with groundbreaking technology. Our labs spaces were built to facilitate collaboration, interaction and cross functional science. We believe employees benefit from being challenged and encouraged at work. We offer everything from bean bag rooms for creative brain storming, game rooms and Zen garden to treadmill stations and regular campus happy hours. The Gaithersburg site offer a variety of amenities to help boost efficiency and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center.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.



What you'll do:

As the Manager Quality Assurance you will be responsible for ensuring the quality of licensed and clinical products manufactured here in Gaithersburg, Maryland.



Responsibilities:

Build a team that is identified as subject matter experts (SMEs) in performance and understanding of biological assays, endotoxin, sterility, mycoplasma, viral testing, and aseptic processingParticipate in and approve laboratory or process deviations, including laboratory investigations.Identify and implement learning and development programs for team members. Ensure that team skills, knowledge, and experience are appropriate and well-balanced to meet team needs.Oversee management of laboratory equipment to ensure regulatory compliance and appropriate availability to meet customer needsServes as SME and Data Integrity champion for laboratory activities as appropriateManage the programs for Environmental Monitoring (EM) and/or Product Testing (PT) and releaseServe on global teams/forums as appropriateOversee and/or write technical reports supporting statistical analysis of data and trending of lab results.Act as a Lean champion, embracing Lean tools and principles and implementing continuous improvement initiativesTrain others on tasks, processes, and equipment in the labsAuthor and approve of quality systems records (eg investigations, CAPAs, SOPs) and technical documents (eg trend reports, qualification and validation documents)



Qualifications

Crucial Education:Bachelor's Degree in a science / technical field such as, Biology, Chemistry, Engineering or equivalent experienceExperienceBachelor's degree in a Science subject2

  • years' experience in a GMP QC Micro lab3
  • years' experience in the pharmaceutical industry3
  • years' supervisory experienceProject Management experienceDesirable: 7
  • years' QC laboratory experiencePost-graduate degree such as Masters or PhD in a Science subjectHigh level knowledge of QC/QA processes and systemsWhy 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 bold - 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 innovative 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 an outstanding fit, please share this posting with them.Date Posted13-Jan-2023Closing DateAstraZeneca 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.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

Recommended Skills

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  • Manufacturing
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