Quality Control Microbiologist, Sweden Biologics
AstraZeneca Södertälje / Biologjobb / Södertälje
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hela Sverige Main Duties and Responsibilities
In this position you will act as Subject Matter Expert for microbiological methods. Performing laboratory tests in accordance with the appropriate cGXP in order to produce reliable and precise data to support product release and scientific investigations. Performs routine tasks accurately and following strict methodologies to carry out analyses. Microbiology testing is including:
• Product Testing - sterility, bioburden, selective organism, Endotoxin and rapid methods.
• Isolate identification.
• Environmental Monitoring / Utilities data reporting.
You will prepares specimens and samples for analysis, write and execute key protocols and reports. You will also be checking of temperature storage units and responding to excursions. In this role, you will undertake a variety of non-routine testing including cleaning validation, complaint, experimental/validation work and analytical support to production. Performing data review/approval and data retention activities and input data for trending purposes. You will also record and as appropriate interprets results to present to senior colleagues.
You will lead Quality Control investigations as require, provide support to functional and cross functional investigations when needed, respond effectively to technical requests from the Quality Control function using expert knowledge of Quality Control instrumentation and methodology to troubleshoot, root cause and solve problems in order to minimise down-time.
Essential Requirements
• Degree level/or equivalent in microbiology or a related discipline.
• Language level: Fluent in both Swedish and English.
Desirable Requirements
• Experience in a Good Manufacturing Practice (GMP) environment / Good Laboratory Practice (GLP).
• Understanding of Quality Control testing techniques.
• Previous Biopharmaceutical Industry experience.
AstraZeneca is a global, innovation-driven biopharmaceutical business 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 world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
This is an exciting opportunity to join our new biologics manufacturing plant at Gärtuna, Södertälje, we are now hiring Quality Control Microbiologists.
The purpose-built facility will supply the next generation of biological drugs from the AstraZeneca pipeline; supporting the acceleration of the biologics portfolio. The new manufacturing plant will focus on the filling and packaging of protein therapeutics for late stage clinical and commercial products.
Our initial plan is to have the first clinical fills in Q4 2018 and first commercial fills in Q4 2019. On top of that we will be starting testing in our micro lab in 2017. In the long term, this site could create up to 250 highly skilled jobs. This site is intended to be the biologics site for late stage clinical and a vast amount of commercial products to increase the biologics manufacturing capacity and meet the needs of the maturing AstraZeneca pipeline. This newly build site will play a big role in our plans for the future.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
Publiceringsdatum2017-03-24Så ansöker duSista dag att ansöka är 2017-04-17
Ange följande referens när du ansöker: R-003679
Klicka på denna länk för att göra din ansökanFöretagAstraZeneca Södertälje
AdressAstraZeneca Södertälje
Karlebyhus, Astraallén
15185 Södertälje
KontorsadressKarlebyhus, Astraallén
Jobbnummer 3397017
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