Quality Systems Specialist - Compliance Team, Philadelphia, PA - Operations
AstraZeneca

Philadelphia, Pennsylvania

Posted in Pharmaceuticals


This job has expired.

Job Info


Do you have expertise in and passion for Quality Assurance 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 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 - Compliance Team in Philadelphia, PA, you will maintain the License to Operate (LTO) for products and processes manufactured at the facility; including interpretation of internal quality standards and external regulatory requirements for the manufacturing of a biologic combination product. Provides support and guidance to other functional teams in Operations, QC, and Quality in areas such as External Inspections & Regulatory Surveillance, Site Self-Inspection Program, Device & Combination Product requirements, Data Integrity requirements, and Annual Product Quality Review. As a QA Compliance Team member, provides direct support to the Validation department for the development and execution of the site Validation Master Plan (VMP). Acts as local process champion and regional process champion for applicable Quality business processes.

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 risks via ownership and continuous improvement of the following business processes to include:

  • Self-Inspections, External Inspections, Regulatory Surveillance, Quality Management Review, Internal Quality Standard Assessments, Device & Combo Products, Validation Support, Site Data Integrity Program, Issue Management, and Recalls
  • 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.
  • Develops personnel through training, mentoring, coaching, and conducting the annual performance development cycle.
  • Ensures growth of the team by identifying areas for staff development and engaging in succession planning.
  • Manages the schedule, recruiting, and hiring of open roles.
  • Utilizes Lean principles, mindset, and ways of working such as problem-solving, 5S, and visual management.
  • Provides leadership and guidance to the cross-functional working team(s) to ensure compliant and timely execution of owned business processes such as Self-Inspections, Product Quality Reviews, Validation planning & execution, and Quality Management.
  • Becomes actively involved in daily operations when required to meet schedules or to resolve complex problems. Provides guidance to staff concerning the US and international regulations and compliance issues.
  • Leads and executes the planning and execution of internal & external regulatory inspections (FDA, EMA, MHRA, etc).
  • Works directly with the Validation department to provide QA support for the development, execution, and review of validation life cycle documents.​


Qualifications:

Education:
  • Bachelor of Science in Biology, Chemistry, Engineering, or related fields is required unless significant meaningful professional experience can be substituted. ​


Required
  • 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.
  • Experience in regulatory inspections (FDA, EMA, MHRA, PDMA, etc)
  • Experience reviewing and approving validation life-cycle documentation.
  • Excellent technical writing skills and communication abilities.
  • Demonstrated ability to work cross-functionally to solve complex problems.​


Desired:
  • 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


This job has expired.

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