QA Specialist - Formulation & Fill OTF/QA Sr. Specialist - Formulation & Fill OTF

The Philadelphia, PA manufacturing site is the home of FluMist, the world's only nasally administered influenza vaccine. The site consists of two geographic locations - a facility at Red Lion Road in NE Philadelphia has about 135 full-time employees and the Bensalem storage and distribution facility has about 6 employees. Our product is aseptically filled and packaged at the Red Lion Road location and is stored for final distribution at the Bensalem location. 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 multiple countries, including the US and UK. Operations continue year-round, with the FluMist production campaign being in the summer (typically April–August). Our site is highly collaborative, and 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 various employee engagement activities. From our famous Wingbowl, to inclusion events, site celebrations, community outreach, and health and wellness activities, there's something for everyone.

Join our Operations team as a QA Specialist - Formulation & Fill OTF or QA Sr. Specialist - Formulation & Fill OTF. These roles provide real-time Quality oversight during the formulation, filling, and packaging operations of LAIV production. Ensuring operations are performed in accordance with cGMPs, you'll make real-time decisions on GDP, GMP, and quality compliance issues. You'll also gain knowledge of both US and international regulatory guidelines and standards. 

You'll provide QA oversight of aseptic processing, implement personnel monitoring within the aseptic processing area using the MODA system, and conduct real-time review of batch records, logbooks, and other associated GMP documents. You'll also assist quality investigations related to deviations and environmental monitoring excursions. You will perform all the duties of a QA Specialist, plus lead seasonal staff, investigate deviations related to production operations, prepare validation protocols and reports, apply risk-based decision making to clarify intricate problems, and provide leadership within and outside of the QA function.

Essential Skills/Experience:

QA OTF Specialist (Specialist I – II):

• Bachelor of Science Degree

• 3 years experience in biopharmaceutical or pharmaceutical industry

• GMP experience in a QA role

• High attention to detail and quality of work

• Flexibility to work shifts as business needs

• Strong organizational skills

• Microsoft Office knowledge.

- QA OTF Senior Associate (Specialist III – IV):

• Bachelor of Science Degree

• 5 years experience in biopharmaceutical or pharmaceutical industry

• GMP experience in a QA role

• High attention to detail and quality of work

• Flexibility to work shifts as business needs

• Strong organizational skills

• Microsoft Office knowledge

• Leadership and project management ability

Desirable Skills/Experience:

- QA OTF Specialist (Specialist I – II):

• Aseptic Processing experience

• Commercial Packaging experience

• Clinical Filling and Packaging experience

• Technical writing skills

• Project management skills

• Operational Excellence / Lean Manufacturing knowledge

- QA OTF Senior Specialist (Specialist III– IV):

• Aseptic Processing experience

• Commercial Packaging experience

• Clinical Filling and Packaging experience

• Technical writing skills

• Project management skills

• Operational Excellence / Lean Manufacturing knowledge

When we put unexpected teams in the same room, we loosen impassioned thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work entirely onsite, but that doesn't mean we're not flexible. We balance the expectation of being at the office while respecting individual flexibility. Join us in our unique and upbeat world!

At AstraZeneca, we take Quality seriously. Our work is important and valued. We're always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. We take a proactive approach that is grounded in sci