Scientific Technical Investigative Writer III - Microbiology

Kelly Services is currently seeking an Technical Investigation Writer for a temp to perm opportunity with one of our top clients Morrisville, NC! The position is responsible for leading investigation activities, identifying root cause failure modes, developing failure specific Corrective and Preventative Actions (CAPAs), and writing deviation investigation reports supporting non-conforming (process and procedural) events.

Must Have:

  • 7 years relevant manufacturing/technical experience in a regulated GMP environment; pharma industry preferred
  • At least 1 year relevant technical writing experience


  • Execute and document comprehensive non-conformance investigations to include, but not limited, the review of the following cGMP documents: batch records, maintenance work orders, engineering/validation protocols, lab results, and historical review of product specific information maintained within the Quality Management System (QMS).
  • Lead or Participate in Site Investigation Rapid Response team.
  • Perform investigations using structured root cause analysis tools (fishbone, 5 Why's, etc) partnering with team members to determine "true" root cause.
  • Conduct personnel interviews of all individuals responsible and/or associated with a non-conforming event.
  • Write a comprehensive, detailed, and accurate event investigation report. The goal is a successful first pass quality review.
  • Write interim reports and extensions for investigations that exceed 30 days.
  • Perform investigations for customer complaints.
  • Write, edit and review plant procedures for accuracy.
  • Perform follow-up activities to coordinate the completion of corrective and/or preventive actions.
  • Perform effectiveness checks for completed corrective actions.
  • Maintain effectiveness of the Quality System components relevant to this position.

 Job Requirements:

  • Bachelor's Degree required, preferably in Sciences or Business (e.g., Chemistry/Pharmacy/Engineering/Operations)
  • Six Sigma or Lean certification a plus
  • Manufacturing quality assurance experience preferred
  • Strong communication/facilitation experience

Apply today for Immediate Consideration!

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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