Senior Specialist, Quality Assurance Position Available In Philadelphia, Pennsylvania

At AstraZeneca, you can be part of crafting the next phase of Operations’ pathway towards the 2025 strategy. Build on our foundations of high performance through agility, responsiveness, reliability and efficiency to deliver our new modalities and complex pipeline to market at speed. Backed by an encouraging team, be part of accelerating our operational excellence with innovations in ground breaking science, Lean ways of working and evolving digital technologies.

THIS IS A 3RD SHIFT POSITION

M-F 10:00PM

• 6:30

AM Accountabilities:

Act as a local process owner/champion for Quality Operations processes: External Audit Readiness

• handle the preparation activities for internal and external inspections, including FDA, EMA, and other regulatory bodies. Develop and implement inspection readiness plans and conduct routine mock inspections to ensure preparedness. Actively participate in audits, inspections, and response process as applicable. Self Inspection Program
• develop and drive the site’s annual self inspection plan to ensure Quality standards are being met in advance of external regulatory audits. Batch Record Review/Approval
• act as the final signatory on production records to ensure data integrity and right first time execution of the production records. Partner with operations teams to remediate errors and improve execution of production standards. Line Clearance and Oversight
• conduct daily walk through inspections (GENBA) of the Aseptic Filling, Pack Operations, and supporting areas throughout the facility to confirm GMP processes and standards are followed. Validation Review/Approval
• support real time review of validation activities and final approval of validation packages to ensure data integrity principles and quality by design.

Work cross functionally with other Quality teams to support: Acceptable Quality Limit (AQL) Inspections Deviation Investigations and CAPA Planning Quality Risk Management Product Complaint Investigations Change Control Planning and Execution GDP Data Review and Trending Partner and support operations functions related to Quality standards and regulatory expectations. Lead and facilitate cross-functional teams, providing support in risk management, compliance and sharing valuable observations and findings. Lead and implement medium to high level simplification and improvement initiatives in collaboration with quality assurance colleagues. Own and update training content and facilitate training sessions focused on quality standards, compliance, and inspection preparation for staff at various levels. Stay continually updated with current industry practices and changes in regulatory guidelines to ensure the organization remains compliant.

Essential Skills/Experience:

• Bachelor’s degree in a Science / technical field such as Pharmacy, Biology, or Chemistry
• 5 years’ experience within pharmaceutical manufacturing and quality
• Experience in business process/ quality system management.
• Strong orientation for continuous improvement and process streamlining and optimization.
• Experience applying Lean principles and driving change initiatives within a structured framework.
• Experience with newer digital tools and technologies related to quality systems management.
• Self-motivated individual that works independently.
• Strong regulatory and compliance experience with an organization such as FDA, MHRA, EMA, ANVISA, HC, and KFDA.
• Effective communication and interpersonal skills are required.

Desirable Skills/Experience:

• Project management experience
• Lean manufacturing experience At AstraZeneca, we are breaking new ground every day.

With constant new products and launches, there’s never been a better time to join our team. We grow with innovation, continuously seeking new ways to deliver life-changing medicines to patients. Our collaborative culture encourages idea-sharing and problem-solving, fostering a positive space where everyone can contribute to our collective success. We are committed to doing things the right way with balanced lifecycle management, making a significant impact on the future of healthcare. Ready to make a difference? Apply now to become part of our dynamic team! Date Posted 10-Jun-2025 Closing Date 29-Jun-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.