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

Kansas Ag Connection

Kansas

On-site

USD 85,000 - 110,000

Full time

4 days ago
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Benefits offered by this job

Relocation packages
8-week parental leave
Employee Resource Groups
Annual bonus offering
Up to 6% 401K matching

Job summary

Elanco Investigation Specialist – Technical Services / Manufacturing Sciences is based in Elwood, Kansas, and leads root cause analyses for monoclonal antibody production with cross-functional teams. The role emphasizes rigorous documentation, CAPA, and compliance within GMP guidelines.

The position requires a STEM degree and at least 3 years in GMP environments, with preferred Six Sigma, DMAIC, or Fishbone training.

Qualifications

  • Bachelor's degree in a STEM-related field.
  • Minimum of 3 years in a GMP-regulated environment with root cause investigations.
  • Strong writing skills for investigation reports, deviations, CAPA, and SOPs.

Responsibilities

  • Lead and facilitate root cause investigations for quality and safety events.
  • Collaborate with cross-functional teams to mentor staff on investigation methodologies and technical writing.
  • Author and review investigation reports, impact assessments, deviations, change controls, CAPAs, and SOPs.
  • Drive continuous improvement through data analysis, Kaizen events, and KPI-driven discussions.
  • Perform risk and impact assessments to support decision-making and regulatory compliance.
  • Ensure adherence to GMP standards and internal quality systems while promoting safety and quality.

Skills

Root cause investigations
Problem solving
Cross-functional collaboration
Technical writing
Documentation
Quality systems

Education

Bachelor's degree in a STEM-related field

Job description

### Job Details#### Job Title:Investigation Specialist - Technical Services / Manufacturing Sciences (TS/MS)#### Location:,, ,#### Company:#### Industry Sector:#### Industry Type:#### Career Type:#### Job Type:Full Time#### Minimum Years Experience Required:N/A#### Salary:### Get Job Alerts**Career Type:** Manufacturing/Production**Country:** USAI agree to receive alerts from and to the .Your alert was created successfully.x## General Alert Saved* The listings below are jobs matching the criteria you've selected for your General Alert on.Criteria selected was:* General alert saved for .* General alert notifications will be sent weekly on Monday.* Please note that you can only have one general alert active at any given time. Creating a new general alert will override an existing general alert.* Visit the to manage your alerts# Investigation Specialist - Technical Services / Manufacturing Sciences (TS/MS)| Number of Years Experience: | Minimum Education Completed: | || Education Major / Discipline Category: | Most Recent / Current Occupation: | |**At Elanco (NYSE: ELAN) - it all starts with animals!****As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.** **At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.****At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.****Making animals' lives better makes life better - join our team today!****Please note, this is a fixed term duration position, you will still be eligible for benefits.****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.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-OnsiteElanco 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 statusElanco 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.To apply please click on APPLY TO THIS POSITIONJob Post Date: 10/31/26Here are some other jobs you may be interested in applying for.| | || - | - || Elanco Elwood, Kansas | Elanco Elwood, Kansas || Elanco Elwood, Kansas | |4 people are interested in this job.
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