Quality Control (QC) Microbiology Specialist

Quality Control (QC) Microbiology Specialist The Quality Control (QC) Microbiology Specialist is responsible for supporting and leading daily operations within the Quality Control microbiology laboratory at the Elwood, Kansas site. This role serves as a subject matter expert for microbiological testing methods and ensures the successful execution, validation, and continuous improvement of QC processes. The Specialist provides leadership and guidance to QC Technicians and peers, oversees lab scheduling and workload delegation, and ensures compliance with quality standards and procedures. This position plays a key role in investigations, audits, method validation, and cross‑functional collaboration with Manufacturing, Validation, and Engineering teams. Your Responsibilities: Review, approve, and report microbiological test data to ensure accuracy and compliance. Lead and support QC activities including deviations, investigations, and change controls. Author and review technical documentation such as SOPs, validation protocols/reports, specifications, study reports, and logs. Coordinate daily lab operations, including scheduling and task delegation across the microbiology team. Serve as a subject matter expert for microbiological methods, equipment, and QC processes. Collaborate cross‑functionally with Manufacturing, Validation, and Engineering teams to support site activities. Perform routine release testing as well as method validation, transfer, and development work. Train, mentor, and provide guidance to QC Technicians and other team members. Ensure compliance with QC policies and identify opportunities to improve or modernize processes. Maintain oversight of lab materials, reagents, and equipment qualification and inventory. Support audit readiness and participate in internal and external audit activities. Drive continuous improvement initiatives within the QC laboratory. Provide updates in site and departmental meetings as needed. Support manufacturing timelines, including occasional off‑hours work when required. What You Need to Succeed (minimum qualifications): Education: Bachelor’s degree in Biological Sciences or a closely related field (or equivalent experience). Experience: Minimum 5 years of relevant experience with a Bachelor’s degree, or 10 years of relevant laboratory experience. Top Skills: Strong understanding of microbiological testing and laboratory operations, with excellent attention to detail and a strong quality mindset. Effective communicator with the ability to collaborate cross‑functionally in a regulated environment, while maintaining a commitment to safety, compliance, and quality standards. Proficient in standard computer applications and systems. What Will Give You a Competitive Edge (preferred qualifications): Advanced degree (M.S. or Ph.D.) in a related scientific field Experience in analytical or microbiology laboratories within regulated industries Prior leadership, training, or mentoring experience Experience with method validation, transfer, and investigation processes Additional Information: Location: Elwood, Kansas Position type: Full‑time (FTE) May involve working with hazardous chemicals Occasional lifting of small loads required Work may include time in refrigerated environments Occasional off‑shift or extended hours may be required to support manufacturing Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply unless they meet every qualification. We are committed to building a diverse and inclusive workplace and encourage you to apply if you believe you could be a strong fit. 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 8-week parental leave 9 Employee Resource Groups Annual bonus offering Flexible work arrangements Up to 6% 401(k) matching 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. Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice. #J-18808-Ljbffr Elanco