QA Facilitator- BCise and Prefilled Syringe Manufacturing- West Chester, OH

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? In Quality, our work is important and valued.  Proactive, science-based, and solutions-oriented, it’s our ambition to go far that keeps pushing us forward. But it’s our pragmatic focus that keeps us delivering what will have the biggest impact on our patients.

Our West Chester Supply Site is a 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 QA Facilitator (BCise and Prefilled Syringe Manufacturing) within the Process Execution Team (PET) is accountable for all QA activities and decisions (end to end) that directly support execution of the PET mission. These activities and decisions include batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, regulatory interactions and may also include incoming material inspection and release. This leadership role, reporting to the Site Quality Lead and the PET Leader (indirectly), is the single point of contact for all QA matters related to PET execution (quality, supply, and cost) and the primary link between the PET and other QA/QC functions.

What you’ll do:

• Develops and maintains a high level of understanding of the technical production process and quality systems being utilized within the Process Execution Team (PET).
• Accountable for all QA decision-making in the PET; works directly with the PET leader and other PET members to deliver all PET objectives.
• Provides direction, development, and performance management to the Quality professionals supporting the PET; serves on the site Quality Assurance Leadership Team (QALT)
• Accountable for the QA review and approval of the following GMP documentation that has direct impact on the activities performed by, and the equipment and facilities utilized by the PET:
  • Change Management (OCM)
  • Batch Release decisions including Field Alert Assessments and Stop Shipments
  • Quality Investigations (Deviations, Product Complaints)
  • Validation Plans, Protocols and Reports
  • Standard Operating Procedures & Risk Assessments
• Interfaces with the Site Support Groups on improvement projects (capital and noncapital) that impact the PET, and proactively ensures GMP compliance during the planning, execution, and closeout phases of these projects.
• Ensures that PET complies with all GMP Compliance and Regulatory requirements by providing proper coaching, mentoring and consultation to the PET leader and PET members.
• Ensures that the QA processes including batch record review, product disposition and quality issues resolutions are executed to maintain the flow of products and documents to meet PET objectives
• Serves as the liaison to global AZ supply sites and quality organizations; may also serve as QA representative to U.S. product supply teams.

Essential for the role:

• Bachelor’s degree in a science/technical field such as Pharmacy, Biology, Chemistry or Engineering or other science related field.
• Minimum of 10 (ten) years of pharmaceutical industry experience with 3+ years of relevant Quality Assurance Experience including supervision.
• Advanced knowledge of cGMP requirements, quality systems, and pharmaceutical manufacturing/packaging technologies.
• Advanced knowledge of regulatory agency interactions and compliance procedures, with ability to apply the knowledge in an operations environment.
• Demonstrated ability to influence leaders in a matrix environment and the personal conviction to make courageous decisions to ensure patient safety and to protect company reputation.

Preferred Requirements:

• Five years of experience in supervisory/managerial roles within QA in the Pharmaceutical Industry
• Advanced degree such as a Master’s degree or higher.
• Multiple site or function experience.
• Lean Six Sigma experience.
• Cross functional and diverse experience within various Quality disciplines (Ex. QA, Compliance, Validation, etc…) or within other areas of the organization (Ex. Operations, OpEx, etc…)

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/

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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.