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:

Performs tasks related to the quality of pharmaceutical products in the Microbiology Department.

• Prepare documentation of activities, actions, and/or results.
• Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.
• Perform visual inspections.
• Verify count, measure and check materials to ensure proper components, quantities, and/or characteristics.
• Establish visual tracking and other tools to enhance Audit readiness and trend analysis.
• Lead and coordinate investigations and studies.
• Investigate deviations.
• Lead training on all document modifications prior to effective date.
• Analyze trends in data in order to provide accurate descriptions, identify root causes, and/or identify solutions or improvements.
• Close out deviations, CAPAs, and/or pAFCAs as needed.
• Check batch records for accuracy and communicate any issues to necessary parties.
• Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area.
• Maintain accurate and complete records (for example: laboratory notebooks, quality records, sample receipts).
• Review and approve quality documentation.
• Lead process improvement activities and teams to meet strategic goals.
• Interact with regulatory agency personnel during audits and inspections.
• Perform regular audits of SOPs (Standard Operating Procedures) and/or work instructions.
• Review, write and approve documentation needed for qualification of equipment and processes.
• Lead teams in root cause analysis sessions.
• Perform routine sampling activities.

Essential for the role:

• 4-year degree in Biology, Microbiology or related discipline
• 3 years of experience in a regulated or cGMP environment.

Desirable for the role:

2 years of experience supporting microbiological testing in a sterile pharmaceutical operations environment

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

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.