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Quality Assurance Specialist, Risk (Quality Systems) Philadelphia, PA - Operations, Philadelphia, Pennsylvania

Job typeFull Time
CountryUnited States
Do you have expertise in and passion for Quality Risk Management and would like to apply your expertise to impact the Quality organization in a company that follows the science and turns ideas into life-changing medicines? Then the Quality Assurance Specialist - Risk Team in Philadelphia, PA at AstraZeneca might be the one for you!

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the global leading pharmaceutical companies.

As a Quality Assurance Specialist - Risk Team in Philadelphia, PA, you will support the manufacture, testing, and release of licensed and clinical material in compliance with both FDA and European regulations including but not limited to cGMPs and GLPSs, NIH/CDC guidelines, and federal, state and local EPA regulations. This role actively participates in the implementation and administration of Quality Systems at the PA sites.

The Philadelphia, PA site manufactures a life-saving influenza vaccine, which is aseptically filled into sprayers for nasal administration. The site consists of two geographic locations - a facility at Red Lion Road in NE Philadelphia has about 140 full-time employees and the Bensalem storage and distribution facility has about 5 employees. The facilities are about 8 miles apart and both are situated close to I-95, the city of Philadelphia, and Philadelphia International Airport. Our product is sold in the US, UK, and other countries. Operations continue year-round, with the production season being in the summer (typically May-August).

Our site is highly collaborative where we show our Philly pride in all we do. We work closely together, always striving to be better every day. We have a network of employee teams who deliver many kinds of employee engagement activities, from our famous Wingbowl, to inclusion events, a site picnic, community outreach, health and wellness activities, and a green team.

What you will do:
  • Support Quality, Compliance, and Operational risk processes via ownership and continuous improvement of the following business processes: Deviation/CAPA Management, Product Quality Complaints, Change Control, Supplier Initiated Changes, Quality Risk Management
  • Lead and execute the above business processes by applying the AZ Business Process Management (BPM) framework to set priorities, balance resource workload, support/empower decision-making, and create high-performing process networks.
  • Utilize Lean principles, mindset, and ways of working such as problem-solving, 5S, and visual management.
  • Partner with the cross-functional working team(s) to ensure compliant and timely closeout of Quality records including risk-based decisions and development of product impact statements for Quality events.
  • Become actively involved in daily operations when required to meet schedules or to resolve complex problems.
  • Provide efficient and effective guidance to staff with respect to the US and international regulations and compliance issues
  • Support and provide key participation in US and EU Regulatory Inspections

  • Bachelor of Science in Biology, Chemistry, Engineering, or related field unless significant meaningful professional experience can be substituted.

  • Minimum of 3 years of experience in the Biopharmaceutical/ pharmaceutical industry
  • Minimum of 3 years of experience in Quality Assurance, Quality Control or Validation
  • Working knowledge of Quality Information Systems (e.g., Trackwise)
  • Understanding of risk management principles and regulatory expectations relevant to Quality risk.
  • Excellent technical writing skills and communication abilities.
  • Demonstrated ability to work cross-functionally to solve complex problems.

  • Six Sigma Certification (Yellow Belt and/or Green Belt)

Why AstraZeneca?

At AstraZeneca, we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We're on an exciting journey to pioneer the future of healthcare.

The challenge to stay ahead in rapidly changing markets is what keeps us driving forward, as we continuously seek new and better ways to deliver medicines all the way to our patients. Our resilience helps us to thrive as we innovate and evolve.

So, what's next?

Are you ready to bring new ideas and fresh thinking to the table? Wonderful!

More on Social Media:
  • LinkedIn https://www.linkedin.com/company/1603/
  • Facebook https://www.facebook.com/astrazenecacareers/
  • Instagramhttps://www.instagram.com/astrazeneca/?hl=en
  • About Operationshttps://www.youtube.com/watch?v=gak5Ham8oUw

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