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

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

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 (preferred qualifications):

• 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

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.