Lead Quality Investigator- West Chester, OH- Operations

Would you like to apply your expertise to impact the Quality Operations in a company that follows the science and turns ideas into life changing medicines? At AstraZeneca, we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. As the voice of the patient, every batch we certify is a personal stamp of approval. A place to take Quality seriously - we draw findings from others to develop and understand what it takes to drive our modern approach forward. Here you’ll feel empowered to step up, follow the science and evidence to make decisions that put patients first.

Our West Chester Supply Site is a very multifaceted 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 and Respiratory. 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.

The Lead Investigator is responsible for performing deviation investigations and driving each event to conclusion by working with others. The Lead Investigator ensures the investigation outcome for deviations and root cause analysis are completed in a timely, effective, and compliant manner. The speed and rigor proven by the Lead Investigator will drive a culture that prevents future deviations through a robust and proactive investigation process.

What you’ll do:

• Conducts coordinated investigations with a well-defined scope, strategy, and timeline detailing status and progress of the investigation.
• Authors reports that detail the investigation of issues including definition, scope, product impact, root cause, and corrective actions to prevent the recurrence of the issue.
• Seeks and leverages the skills and technical expertise of internal and external resources to improve the speed and rigor of investigations.
• Collaborates with a cross functional team to determine:
  • Communication strategy so all stakeholders have appropriate information.
  • Investigation strategy including a clear and actionable problem statement.
  • Investigation tools.
  • Investigation action plan and timing.
  • Root cause.
  • Solution selection.
  • CAPA action plan and effectiveness checks.
• Utilizes the appropriate and approved investigation tools vital to drive the team to root cause.
• Prioritizes work to aid in timely decisions and completion of investigations. Escalates issues as appropriate.

Essential for the role:

Minimum Requirements:

• Bachelor’s degree, scientific discipline preferred.
• Minimum three (3) years of experience in a pharmaceutical production or quality control environment.
• Experience working in a cGMP environment.
• Ability to quickly assess and assimilate technical data and conduct a detailed investigation; ability to present findings, conclusions, and sophisticated information in a clear, concise, and logical manner.
• Excellent written, verbal, and presentation skills.
• Attention to detail and data integrity is essential. Ability to supervise activities to accomplish stated objectives in an effective manner.
• Must be able to work in a fast-paced and rapidly changing environment. Ability to prioritize work activities to meet customer needs and deadlines.
• Must be proficient with Microsoft Office Suite and have a solid understanding, or the ability to learn, computer systems such as TrackWise, SAP, LIMS, and Electronic Batch Record Systems.
• Must be able to take accountability with excellent follow up and follow through; owns issues through the full cycle investigation process.

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. 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:

LinkedIn https://www.linkedin.com/company/1603/

Facebook https://www.facebook.com/astrazenecacareers/

Instagram https://www.instagram.com/astrazeneca/?hl=en

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.