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Manufacturing Specialist Investigator

GPS Staffing West Greenwich ,RI
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

GPS Staffing is a nationwide preferred provider of staffing and recruitment services. GPS has over 25 years of dedicated staffing partnerships with organizations ranging from International Fortune 500 companies to Colorado startups. Our team is committed to Growth, People and Success!
 
Title: Manufacturing Specialist Investigator
Job ID: 7165
Industry: Biotech/Pharmaceutical
Location: West Greenwich, RI
Duration: 6-Month Contract (w/ possible extension)
Pay Rate Range: Depends on Experience (hourly, w2)
 
Job Details:

  • *2 positions available, must sit on site M-F when the site re opens*
  • Company's Rhode Island Operations is currently seeking a Manufacturing Specialist Investigator (External worker) in our site Investigation group.
  • In support of companies 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.

 
Responsibilities:

  • Lead root cause analysis to identify the failure mode using root cause analysis
  • Identify root cause using tools such as fishbone diagrams, "5 Whys”, KT, Process mapping, and risk assessments such as FMEA's or Fault Tree Analysis.
  • Applies knowledge and subject matter expertise to ensure end-to-end of investigations
  • Lead discussion to reduce correct, mitigate and prevent the re-occurrence of the event based on output of root cause analysis.
  • Perform trend investigations, including statistical assessment of data to identify trends, as well as generation of reports (as needed)
  • Generate final technical reports in accordance with established procedures, which may include data collection and statistical analysis of the data
  • Develop in conjunction with the technical team product impact assessment in support of investigations
  • Perform notification of potential product impact in accordance with established procedures
  • Advise management on investigation progress, product/ process risk, and potential delays in the investigation process.
  • Support functional management initiatives and objectives
  • Anticipates and prevents potential issues with regulators
  • Own and/or Drive Improvement projects/initiatives
  • Collaborate cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures.
  • Alert senior management of quality, compliance, supply and safety risks.
  • Attend and contribute to staff meetings and attend appropriate training sessions, as required.
  • Lead safe working practices and safety initiatives within their functional area.

 
Required Skills:

  • 2+ years of experience in investigation process industry experience, non academia within biopharm 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)

 
Preferred Skills:

  • 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 Skills:

  • 2+ years of experience in investigation process industry experience, non academia within biopharm environment
  • Must have previous technical writing experience, experience In investigation process (RCA) and Drug Substance Experience.

 
Educational and Experience Requirements:

  • 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
  • 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

           
Note to Applicants:
We will not respond to everyone personally - qualified candidates will be contacted for a screening.
Please submit your resume in a Word document.
 

Company Description
GPS Staffing is a nationwide preferred provider of staffing and recruitment services. GPS has over 25 years of dedicated staffing partnerships with organizations ranging from International Fortune 500 companies to Colorado startups. Our team is committed to Growth, People and Success!

GPS Staffing

GPS Staffing is a nationwide preferred provider of staffing and recruitment services. GPS has over 25 years of dedicated staffing partnerships with organizations ranging from International Fortune 500 companies to Colorado startups. Our team is committed to Growth, People and Success!

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West Greenwich, RI
USA

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