Specialist, Quality Assurance Position Available In Philadelphia, Pennsylvania

Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It’s inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people’s lives better

• from patients and their families to all of us in society.

THIS POSITION IS FOR

3rd

SHIFT:

M-F 10pm

• 6:30am. Accountabilities Support specific Quality Operations processes within assigned area:
• External Audit Readiness
• support the preparation activities for internal and external inspections, including FDA, EMA, and other regulatory bodies. Support inspection readiness plans and conduct routine mock inspections to ensure preparedness. Assist in audits, inspections, and response process as applicable.
• Self Inspection Program
• Assist in developing and driving 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 protect 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: o Acceptable Quality Limit (AQL) Inspections o Deviation Investigations and CAPA Planning o Quality Risk Management o Product Complaint Investigations o Change Control Planning and Execution o GDP Data Review and Trending
• Partner and support operations functions related to Quality standards and regulatory expectations.
• Provide mentorship and support to cross-functional teams, in risk management, compliance and sharing valuable observations and findings.
• Lead and implement simplification and improvement initiatives in collaboration with other quality assurance colleagues.
• Help update training content and support 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. Required Skills/Experience
• Bachelor’s degree in a Science / technical field such as Pharmacy, Biology, or Chemistry
• 3 years’ experience within pharmaceutical manufacturing and quality
• Strong orientation for continuous improvement and process streamlining and optimization.
• Experience applying Lean principles and motivating change initiatives within a structured framework.
• Self-motivated individual that works independently.
• Effective communication and interpersonal skills are required. Desirable Skills/Experience
• Project management experience
• Lean manufacturing experience
• Some experience in business process/ quality system management.
• Knowledge of/ experience with newer digital tools and technologies related to quality systems management.
• Regulatory and compliance experience with an organization such as FDA, MHRA, EMA, ANVISA, HC, and KFDA.

At AstraZeneca, we are driven by a strong connection to our patients. Our mission is to find the best solutions to put our patients first. Here, you will play a critical role in delivering innovative medicines all the way until they reach our patients. We grow with challenges, continuously seeking new ways to deliver life-changing medicines. Our collaborative environment encourages sharing ideas and problem-solving as a team. With constant new products and launches, there has never been a better time to join us. Ready to make a big impact? Apply now! 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.