Technical Investigation Writer

Woodstock, IL

Posted: 10/16/2019 Job Number: JN -102019-11166

Job Description

Technical Investigation Writer (cGMP):

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
  • Title: Technical Investigation Writer
  • Location: Woodstock, IL
  • Industry: Pharmaceutical
  • Hours: Monday-Friday; 8:00 am 5:00 pm
  • Salary: $40.00-$42.00 hour paid weekly with benefits options
  • Employment Type: Contract 3-6 months with possible extension or conversion
Environment: This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers. Our customer believes in a Patient First culture putting patients at the center of their work to ensure the safety, reliable supply and optimal performance of our products. Isn t this the type of company you want to work for?

Job Scope: This position is responsible for leading investigation activities, identifying root cause failure modes, developing failure specific CAPAs, and writing deviation investigation reports supporting non-conforming (process and procedural) events.
  • 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.

Skills Needed:
  • Bachelor's Degree in Sciences or Business (Chemistry, Pharmacy, Engineering, or Operations)
  • 2-5 years relevant manufacturing/technical experience
  • 1-3 years relevant technical writing experience
  • Six Sigma or Lean certification a plus
  • Manufacturing quality assurance experience preferred
  • Strong communication/facilitation experience
  • Peer mentoring and developmental leadership
  • Experience with Trackwise or other quality management investigation software/tools
  • Working knowledge of cGMP and safe work practices
  • Proven experience working in a technical writing position

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