Senior Quality Control Analyst - Operations (Philadelphia, PA)
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.
In this role as Senior Quality Control Analyst, you will be responsible for conducting investigations, writing trend reports, routine and non-routine analysis of environmental samples, raw materials and in process samples according to standard operating procedures..
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.
- Prepares investigation reports, including those related to OOSs, deviations, EM and Utilities excursions.
- Reviews data obtained for compliance to specifications and reports abnormalities.
- Maintain quality and assay performance metrics (i.e. right first time, invalid assay, quality oversight)
- Responsible for writing new standard operating procedures or revising existing documentation.
- Prepares validation protocols, executes experiments, and prepares validation reports
- Play active role in training seasonal and entry level QC Analysts.
- Applies knowledge of good manufacturing practices and good laboratory practices on a daily basis.
- Applies critical thought to solving problems of complex scope.
- Works on complex problems requiring an in-depth knowledge of scientific methods and techniques.
- Acts independently to determine methods and procedures on new assignments.
- Prepares documentation for presentation to Regulatory Agencies.
- Bachelor’s Degree Microbiology or related discipline.
- 4+ years of experience working in regulated QC laboratory
- Language Skills: Ability to read, analyse, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to write reports, business correspondence, and procedure manuals.
- Experience in Aseptic manufacturing operations.
- Experience with WFI water testing.
- Experience with Quality Control laboratory method and equipment validation.
Next Steps – Apply today!
To be considered for this exciting opportunity, 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. If you know someone who would be a great fit, please share this posting with them.
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 authorisation and employment eligibility verification requirements.