Do you have experience in Quality Information Systems, Quality Assurance, Quality Control or in Validation within the Biopharmaceutical/pharmaceutical industry? Then this position is the right fit for you!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

The Philadelphia, PA site manufactures a life-saving influenza vaccine. Our product 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.

The Quality Assurance Specialist (Quality Systems) in Philadelphia, PA is responsible for supporting 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.

What you will do:

• Ensure site compliance is maintained for all operations.
• Maintain procedures and provides direct QA support to the documentation and resolution of deviations, environmental monitoring excursions and manufacturing investigations; issue trend reports to track status of deviations/excursions, and Corrective Actions, ensures corrective actions are implemented.
• Support the Product Quality Complaint process, including management of complaint investigations, perform periodic complaint trending, reporting of key process metrics.
• Support the responsibility of the Quality Systems team for generation of Annual Product Review documents.
• Support and provide key participation in US and EU Regulatory Inspections
• Provide computerized Quality Systems Training (TrackWise) for Manufacturing, Quality Control, Facilities, Materials Management and Quality Assurance Personnel
• Participate in interdisciplinary Projects as the need arises

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 five (5) years proven track record within the Biopharmaceutical/pharmaceutical industry.
• Minimum of four (4) years proven experience within Quality Assurance, Quality Control or Validation.
• Working and understanding of Quality Information Systems (e.g., Trackwise).
• Excellent technical writing skills.

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. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking cutting-edge methods and bringing unexpected teams together. Come join us.

Next Steps – Apply today!

Are you ready to bring new ideas and fresh thinking to the table? We have one seat available, and we hope it’s yours. Curious to know more, then 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. Know someone who would be an excellent fit, please share this posting with them.

Find out more on Social Media:

• LinkedIn https://www.linkedin.com/company/1603/
• Facebook https://www.facebook.com/astrazenecacareers/
• Instagram https://www.instagram.com/astrazeneca_careers/?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.