Quality Control /Environmental Monitoring Technician (R&D)
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: Quality Control /Environmental Monitoring Technician
Environmental Monitoring / QC Technician Microbiology will report to the QC Supervisor, Microbiology or equivalent. This position will conduct routine and non-routine environmental monitoring of the manufacturing facilities and associated utilities, as well as microbiology analysis.
Your Responsibilities:
- 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.
- Ensure the QC lab is held to cGMP, safety, and environmental standards as well as generate and report accurate data that meet regulatory compliance, support equipment validation, calibration, and maintenance; and participate in internal assessments and audits as required.
- 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.
- Assist in preparation of Certificates of Analyses, OOS/OOT Investigations, EM and Facility Investigations, and Deviations during testing. Assist in developing and qualifying/validating new testing methods and method transfers. Write and revise testing methods. Assist in the development of specifications and justification of specifications. Assist in the preparation of QC standard operating procedures and forms. Assist in preparation of QC method validation protocols/reports and other analytical study reports. Assist in the recommendation of new technologies and methods.
- Maintain QC Microbiology inventory, perform daily temperature checks on necessary equipment, and perform weekly cleaning of laboratory spaces. Provide production support and participate in production fills and aseptic process simulations.
What You Need to Succeed (minimum qualifications):
Education: High School Diploma/GED with 5years experience, BA or BS degree in Microbiology, Biological Sciences, Pharmaceutical Sciences, or closely related field, or comparable experience.
Experience: Technical skills in Environmental Monitoring to include, but not limited to, monitoring of manufacturing environment and utilities.
Excellent computer, documentation, communication, and organizational skills required.
What will give you a competitive edge (preferred qualifications):
Experience in cGMP environment preferred
Experience with environmental monitoring, water testing, sterility, and mycoplasma 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:
Travel: >5%
Location: Elwood, Kansas
Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
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Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
