Technical Operations & Quality Investigations Specialist

TL;DR

Technical Operations & Quality Investigations Specialist: Provide technical support to manufacturing teams by investigating atypical events, driving root-cause investigations, and implementing CAPA to maintain process integrity. Focus on audit-ready technical reporting, cross-functional problem resolution, and applying Lean Six Sigma to reduce process deviations and improve manufacturing workflows.

Company

hirify.global supports manufacturing teams with technical staffing for quality and operations roles.

What you will do

• Lead investigation of atypical events and production deviations to identify systemic root causes.
• Develop and implement corrective and preventative actions (CAPA) to prevent recurrence.
• Maintain process integrity by applying scientific and engineering principles to keep processes within defined specifications.
• Author accurate, clear, audit-ready technical investigation reports.
• Partner with manufacturing, quality, and process development teams to resolve technical issues and improve communication.
• Use Lean Six Sigma to analyze production data and recommend improvements to manufacturing workflows.

Requirements

• B.S. or M.S. in an engineering or scientific discipline (e.g., chemical engineering, biology, chemistry, or related field).
• 0–3 years of professional experience in a cGMP manufacturing environment (e.g., production, process engineering, or technical services).
• Proven ability to write technical investigations for atypical events or deviations.
• Strong critical thinking and analytical problem-solving skills, including Lean Six Sigma methodology.
• Exceptional written communication skills to document technical events clearly and defensibly for audits.

Culture & Benefits

• Major medical, dental, vision, and 401k benefits for temporary assignments lasting 13 weeks or longer.
• 401k and statutory sick pay where required.
• Reasonable accommodations available during the employment process.
• Equal opportunity employer with support for protected veterans and individuals with disabilities.