Quality Control Specialist, Biochemistry

Your Role: QC Specialist. Biochemistry

The QC Specialist is responsible for the daily operations and technical leadership of the Quality Control laboratory. This role serves as a subject matter expert for analytical methods and equipment, owning critical processes including method validation, investigations, and the direction of daily workloads for QC Technicians. The Specialist ensures strict adherence to quality policies while driving continuous improvement and collaborating with leadership to optimize laboratory processes.

Your Responsibilities:

• Lead Lab Operations: Direct the regular workload for Technicians and other Specialists, ensuring QC policies are followed and acting as the primary point of contact for technical instruction or clarification.
• Method Ownership: Perform regular release testing and lead specialized development experiments, including participating in or owning method validations and technical transfers.
• Quality Event Management: Regularly lead and own quality events, including deviations, laboratory investigations, and change controls.
• Technical Review & Audit: Act as a reviewer for QC Technicians and other Specialists; audit inventory management and ensure reagent/material qualifications are maintained.
• SME Leadership: Serve as a Subject Matter Expert (SME) for specialized laboratory equipment, coordinating routine maintenance schedules and ensuring compliance.
• Continuous Improvement: Partner with the QC Leader to identify and improve obsolete processes, anticipating potential problems and finding effective solutions to improve lab systems.
• Compliance & Audit Readiness: Participate in audit activities and proactively prepare the laboratory space for inspections by anticipating potential issues.
• Safety & Culture: Personify Elanco values of Integrity, Respect, and Excellence while fostering an environment of safety, compliance, and inclusion.

What You Need to Succeed (minimum qualifications):

• Education: Bachelor’s Degree in Biochemistry, Biological Sciences, Pharmaceutical Sciences, or a closely related field.
• Experience: 4+ years of relevant experience in a laboratory or quality environment.
• Top Skills: Strong verbal, written, and interpersonal communication skills; proficient computer literacy; and the ability to work with and lead a diverse group of colleagues. Must possess a “quality mindset” with a deep understanding of quality expectations and compliance.

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

• Advanced degree (M.S. or Ph.D.) in Biology, Chemistry, or an associated science with 2+ years of experience.
• Hands-on experience with HPLC and ELISA techniques.
• Proficiency using Empower and/or Softmax software platforms.
• Direct experience in analytical laboratory operations and leadership or training roles.
• Strong attention to detail and a proven track record of acting as a leader of change.

Additional Information:

• Location: Elwood, Kansas
• Shift: Primarily day shift; however, the ability to occasionally support manufacturing timelines outside of normal operating hours is required.
• Travel: Minimal travel requirements.