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As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
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.
Basic Minimum Requirements:
- High School Diploma/GED with 5years experience, 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.
- Excellent computer, documentation, communication, and organizational skills required.
- Completion of Post Offer Exam (POE), Completion of Work Simulation (SIM) or Completion of Administrative Skills Testing if applicable.
- Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
- Conduct routine and non-routine Microbiology based analysis of raw materials, in-process materials, finished goods, and stability samples.
- Perform routine and non-routine environmental monitoring (air viable, air non-viable, and surface sampling) of manufacturing environments.
- Perform monitoring of utilities to include WFI, USP Water, Pure Steam, and Clean Compressed Air.
- Conduct microbiology testing to include total organic carbon, conductivity, endotoxin, bioburden, growth promotion, mycoplasma, sterility, microbial identifications, gram stains, and personnel sampling.
- Execute gowning qualification personnel performing activities in classified sterile environments.
- Provide production support and participate in production fills and aseptic process simulations.
- Participate in internal assessments and audits as required.
- 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 preparation of QC standard operating procedures and forms.
- Support equipment validation, calibration, and maintenance.
- 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.
- Ensure the QC lab is held to cGMP, safety, and environmental standards.
- Generate and report accurate data that meet regulatory compliance.
- Achieve and maintain gown qualification for sterile environments.
- 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.
- Use of instrument software to obtain results.
- Strong attention to detail, strong problem-solving skills, as well as the ability to work in a cross-functional team environment.
- Experience with Microsoft Office (Microsoft Word, Excel, PowerPoint, and Outlook)
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