Non-IT

Quality Investigator and Author

Contract-to-Hire

Medasource

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Position: Quality Investigator and Author  

Location: Worcester, MA 

Start Date: ASAP 

Duration: 12-month contract to hire  

Job Description: 

As an Investigation Owner you will be responsible for creating comprehensive project plans, budgets, objectives, strategies and deliverables. The ideal candidate has experience in determination of root cause, and initiation of corrective actions designed to address the quality related deficiencies identified during the investigation process.  

Investigation Owner Minimum Qualifications: 

  • B.S. degree in science or technical related field  
  • 3-5+ years of experience in manufacturing, engineering, quality & project management, supply chain, or customer service 
  • PMP Certification a plus, but not required  
  • Experience in TrackWise, or similar program experience, required 
  • Strong understanding of CAPA Quality system tools to drive and document Root Cause Analysis  
  • Knowledge and understanding of manufacturing processes  
  • Strong strategy development and planning skills 
  • Background in Technical Writing, creating and writing investigation reports

Responsibilities: 

  • Drive the investigation and closure of nonconformance events (NCRs) while working with team of scientific, engineering, quality and production subject matter experts  
  • Author investigation reports and compile required attachments  
  • Translate investigation and closure plan into measurable actions while executing against functional procedures and processes  
  • Maintain compliance with regulatory agencies, functional systems, ethics policies and project goals  
  • Establish and host periodic updates to management of process  
  • Recommend innovative ways to improve efficiency and quality; anticipates roadblocks and elevate when appropriate 

What’s In It For You: 

  • The opportunity to join a global, renowned pharmaceutical company 

Medasource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.

JO-2108-114082

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