Assistant II - Quality Control (Hourly)

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your Role: Assistant- Quality Control

QC Technician, Microbiology will report to the QC Supervisor, Microbiology or equivalent. This position will conduct routine and non-routine microbiology analysis and environmental monitoring. In addition to, monitoring utilities and maintaining microbiology inventory, etc.

Your Responsibilities:  

• Conduct routine and non-routine Microbiology based analysis of raw materials, in-process materials, finished goods, and stability samples; and conduct microbiology testing to include total organic carbon, conductivity, endotoxin, bioburden, growth promotion, mycoplasma, sterility, microbial identifications, gram stains, and personnel sampling.
• Perform routine and non-routine environmental monitoring (air viable, air non-viable, and surface sampling) of manufacturing environments and perform monitoring of utilities to include WFI, USP Water, Pure Steam, and Clean Compressed Air.
• Execute gowning qualification personnel performing activities in classified sterile environments as well as achieve and maintain gown qualification for sterile environments.
• Provide production support and participate in production fills and aseptic process simulations, and support equipment validation, calibration, and maintenance.
• Participate in internal assessments and audits as required, generate and report accurate data that meet regulatory compliance and ensure the QC lab is held to cGMP, safety, and environmental standards; and maintain QC Microbiology inventory, perform daily temperature checks on necessary equipment, and perform weekly cleaning of laboratory spaces.
• Assist in preparation of Certificates of Analyses, OOS/OOT Investigations, EM and Facility Investigations, and Deviations during testing; developing and qualifying/validating new testing methods and method transfers; write and revise testing methods; the development of specifications and justification of specifications; the preparation of QC standard operating procedures and forms; the preparation of QC method validation protocols/reports and other analytical study reports; and assist in the recommendation of new technologies and methods.

What You Need to Succeed (minimum qualifications): 

•  Education: High School Diploma/GED with 5years experience; or a BA or BS degree in Microbiology, Biological Sciences, Pharmaceutical Sciences, or closely related field; or comparable experience.

• Technical skills in microbiology to include, but not limited to aseptic technique, sterile gowning, and pipetting are required.
• Knowledge of troubleshooting and laboratory investigations.
• Excellent computer, documentation, communication, and organizational skills required. 

What will give you a competitive edge (preferred qualifications): 

• Experience in cGMP environment preferred
• Experience with sterility, mycoplasma, environmental monitoring, and water testing preferred.
• Knowledge of pharmaceutical cGMPs (US and EU), FDA, USDA, VICH, EU as related to QC activities
• Experience related to method development/validation.
• Strong attention to detail, strong problem-solving skills, as well as the ability to work in a cross-functional team environment.

Additional Information:  

• Location: Onsite at Elwood, Kansas Facility

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