Quality Control Technician, Microbiology

As an Quality Control Technician, Microbiology, you will be an important member of the Quality Control team, supporting microbiology testing, environmental and utility monitoring, sample management, and laboratory operations. In this role, you will help ensure accurate, compliant testing and documentation while supporting sterile manufacturing operations in a cGMP environment.

Your Responsibilities:

Perform routine and non-routine environmental monitoring, including viable/non-viable air, surface, personnel, and manufacturing area sampling.

Monitor and test critical utilities, including WFI, USP Water, Pure Steam, and Clean Compressed Air.

Conduct microbiology testing of raw materials, in-process materials, finished products, and stability samples, including endotoxin, bioburden, mycoplasma, and sterility testing.

Perform microbiology support activities including media growth promotion, gram staining, microbial identification, and other laboratory testing.

Provide production support through production fills and aseptic process simulations while maintaining sterile gowning qualifications.

Support quality investigations and documentation, including OOS/OOT investigations, environmental and facility investigations, deviations, Certificates of Analysis, SOPs, and controlled documents.

Assist with method development, validation, qualification, method transfers, and analytical studies, as well as equipment validation, calibration, and maintenance.

Maintain laboratory operations, inventory, equipment checks, cleanliness, and accurate data while ensuring compliance with cGMP, safety, environmental, and regulatory requirements.

What You Need to Succeed (minimum qualifications):

Education: High School Diploma/GED with 5 years of relevant experience, or a Bachelor’s degree in Microbiology, Biological Sciences, Pharmaceutical Sciences, or a closely related field.

Experience: Experience in a laboratory or technical environment with microbiology responsibilities.

Top 2 skills: Strong technical skills in microbiology, including aseptic technique, combined with strong documentation, communication, and organizational skills.

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

Experience working in a cGMP-regulated environment.

Experience with sterility testing, mycoplasma, environmental monitoring, and water testing.

Knowledge of pharmaceutical cGMP requirements and applicable FDA, USDA, VICH, and EU regulations related to QC activities.

Experience with analytical method development, validation, qualification, or method transfers.

Experience using instrument software to obtain and manage laboratory results.

Strong problem-solving and attention-to-detail skills with the ability to work effectively in a cross-functional team environment.

Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.

Ability to support a physically demanding laboratory environment, including extended periods on your feet and moving heavy materials or supplies.

Additional Information:

Schedule: Regular day shift working hours

Location: 1411 Oak Street, Elwood, KS 66024

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:

8-week parental leave

9 Employee Resource Groups

Annual bonus offering

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

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