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Manufacturing Specialist Investigator (JP7972)

West Greenwich, Rhode Island · Biotech/Pharmaceutical
Job Title: Manufacturing Specialist Investigator (JP7972)
Location: West Greenwich Rhode Island 02817
Employment Type: Contract
Duration: 6 months with likely extensions
Job posting date: 2 December 2020
Note: Candidate will be working remote in EST & required to be on site once it re opens
3 Key Consulting is hiring a Manufacturing Specialist Investigator for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Job Summary:
Companies Rhode Island Operations is currently seeking a Manufacturing Specialist Investigator (External worker) in our site Investigation group. In support of company’s mission to serve patients, we are a diverse team working to continuously improve our clinical and commercial drug Substance Operations to ensure supply and to optimize the patient experience. The Manufacturing Specialist Investigator - conducts technical investigations from our clinical and commercial drug Substance Operations. This role understands the investigation process as well as manufacturing processes for the Rhode Island Facility. The Manufacturing Specialist Investigator owns major and trend deviations to support identifying root cause and will also participate in multi-functional idealization of design solutions (CAPAs). Also maintains close interaction with the Manufacturing leads, engineering, Process Development, Quality Controls, Supply Chain, and quality functions to mitigate product impact and contribute to product/process improvement.

  • Doctorate degree OR Master’s degree and 3 years of Bio pharmaceutical Operations experience OR Bachelor’s degree and 5 years of Bio pharmaceutical Operations experience.
  • 2+ years of experience in investigation process industry experience, non-academia within biopharma environment.
  • Must have previous technical writing experience, experience In investigation process (RCA) and Drug Substance Experience.
  • Demonstrate understanding and application of Drug Substance process, data mining, Microsoft office tool, Quality, and compliance.
  • Strong technical writing and interpersonal skills (able to influence tri functional team and organizational leads)

    Ideal Candidate:
  • Demonstrated Six Sigma proficiency specifically for root cause analysis methodology.
  • Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
Top Must have Skill Sets:
  • Experience in Root Cause Analysis
  • Experience in Drug Substances
  • Fast learner
 Day-To-Day Responsibilities:
  • Investigate nonconformity events at the site.
  • Follow up, coordinate meeting, and communicate decisions.
  • Lead multifunctional team meetings
Employee Value Proposition:
Opportunity to join a fast-paced team with exposure to different departments and leadership.
Red Flags:
No experience in investigation process
No experience in Biologic Products
Interview Process:
Phone, panel interview 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team

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