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.

Our West Chester Supply Site is a very dynamic and growing manufacturing site within the AstraZeneca Global Operations network and is located just north of Cincinnati, Ohio. In addition to serving as the global COVID vaccine production site for AstraZeneca, the West Chester site encompasses Bulk API Microsphere manufacturing, Aseptic Pharmaceutical Formulation, multi-line Isolator/Barrier Vial and Syringe Filling, and specialty Packaging Operations for Vials and Auto-Injectors that supports growing franchises in Diabetes, Respiratory, and Vaccines. Our site is one of 30 production facilities in 18 countries with over 700 people collaborating to connect powerful medications to patients in more than 60 countries around the world. We focus on providing a collaborative environment where everyone feels comfortable and able to be themselves. Being able to bring your full self to work every day is at the core of AstraZeneca’s priorities. On-site amenities include a Health and Wellness clinic, as well as a Cafeteria Grille serving breakfast and lunch items for employees and guests. We also have a Great Place to Work Counsel, involving committees of employees who coordinate several activities related to community outreach, sustainability, health and wellness and social events

What you'll do:

• Participates in investigations for PET process areas, related to QC processes or data.
• Performs testing on a range of samples, including raw materials, in-process, finished products, stability samples, water, gas, and environmental samples.
• Conduct GMP review of laboratory documentation including review of electronic data in a timely manner for compliance with applicable SOPs, test methods, regulations, and protocols. Communicate findings to analysts and follow up on corrections.
• Assist in authoring and finalizing departmental SOPs.
• Evaluates data trends and actively participates in the investigation of OOS and atypical events and/or quality issues placing particular attention to root cause analysis, technical completion and scope while ensuring accuracy of documentation contents.
• Maintains and troubleshoots testing equipment.
• Trains QC employees in good aseptic techniques, methods and instrumentation based on expertise.
• Actively support the implementation of compendial changes for raw materials, in-process or finished products tests in accordance with applicable Pharmacopoeias such as USP/NF, European Pharmacopeia, British, and Japanese Pharmacopeia.
• Troubleshoots methods and processes.
• Leads continuous improvements in laboratory processes.

Essential for the role:

• Bachelor’s degree in a Science subject (Microbiology, or closely related subjects).
• At least 3 years laboratory experience.
• Ability to coach and mentor peers.
• Working knowledge of cGXP requirements and a strong familiarity with production operations.
• Excellent attention to details

Desirable for the role:

• 5 years QC microbiology laboratory experience
• High level of knowledge and competence with a specific piece of laboratory equipment, or a QC/QA process or system.

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, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey!

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.

Find out more on Social Media:

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About Operations https://www.youtube.com/watch?v=gak5Ham8oUw

Date Posted

07-Jul-2021

Closing Date

24-Oct-2021

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.