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).

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.
• A strong understanding of quality systems, including deviations, CAPA, and change control processes.

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.