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

POSITION DETAILS:

  • 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 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 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 Services®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

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