Sr. Technical Investigation Writer IV - Morrisville, NC

Compensation

: $95,370.00 - $141,430.00 /year *

Employment Type

: Full-Time

Industry

: Engineering





Senior Investigative Writer IV - Morrisville, NC.

Kelly services is currently hiring for one of our top clients in Morrisville, NC! We're seeking top quality candidates for a Senior Investigative Technical Writer with the experience to succeed with our esteemed client. 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. To be successful, this individual effectively leverages key investigational tools such as; root cause analysis (RCA), 5-why analysis, and/or fishbone diagrams. This role will engage/communicate with all levels of site leadership on the status of all investigations. Responsibilities:

  • 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 RCA 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.

Education:

  • Bachelor's Degree required, preferably in Sciences or Business (e.g., Chemistry/Pharmacy/Engineering/Operations)

Experience:

  • 10+ years relevant manufacturing/technical experience in a regulated GMP environment; pharma industry preferred
  • 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


Why Kelly®?

As a worker today, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




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/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.



Job Requirements:
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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