Investigation Specialist - Technical Services / Manufacturing Sciences (TS/MS)

Your Role

The Investigation Specialist - Technical Services / Manufacturing Sciences (TS/MS) is responsible for leading and supporting root cause analysis and quality event management for monoclonal antibody (mAb) production at the Elwood, Kansas site. This role partners closely with cross-functional teams to drive thorough investigations, ensure high-quality documentation, and implement effective corrective and preventive actions (CAPA). The position plays a key role in strengthening compliance, improving processes, and fostering a culture of quality and continuous improvement.

Your Responsibilities

• Lead and facilitate root cause investigations for quality and safety events, ensuring timely, thorough, and compliant resolution.
• Collaborate with cross-functional teams to support and mentor staff on investigation methodologies and technical writing best practices.
• Author and review technical documentation including investigation reports, impact assessments, deviations, change controls, CAPAs, and standard operating procedures (SOPs).
• Drive continuous improvement initiatives through data analysis, Kaizen events, and KPI-driven discussions to enhance manufacturing performance.
• Perform risk and impact assessments to support decision-making and ensure regulatory compliance.
• Ensure adherence to GMP standards and internal quality systems while promoting a strong culture of safety, quality, and accountability.

What You Need to Succeed (minimum qualifications)

• Education: Bachelor's degree in a STEM-related field.
• Experience: Minimum of 3 years of experience in a GMP-regulated environment, with at least 2 years leading or supporting root cause investigations.
• Top 2 Skills: Strong root cause investigation and problem-solving capabilities; and the ability to collaborate cross-functionally while producing clear, high-quality technical documentation. Strong understanding of quality systems, including deviations, CAPA, and change control processes.

What will give you a competitive edge

• Experience in commercial monoclonal antibody or recombinant protein manufacturing.
• Demonstrated strength in technical writing and documentation.
• Six Sigma Green Belt (or higher) or equivalent continuous improvement training.
• Formal training in root cause analysis methodologies (e.g., DMAIC, 5 Whys, Fishbone).
• Proven ability to collaborate across cross-functional teams, with strong coaching and communication skills.

Additional Information

• Location: Elwood, Kansas
• Travel: Occasional (<10%)
• This role operates during standard business hours with occasional off-hours support in a 24/7/365 manufacturing environment.

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 this 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
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Up to 6% 401K matching

• #LI-HL
• #LI-Onsite

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.