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Manufacturing Specialist Investigator

AgreeYa Solutions West Greenwich ,RI
  • Expired: over a month ago. Applications are no longer accepted.
Job Description
  • Companies 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.


Top 3 Must Have Skill Sets:    

  • Doctorate degree OR Masters degree and 3 years of Bio pharmaceutical Operations experience OR Bachelors degree and 5 years of Bio pharmaceutical Operations experience
  • 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.


Day to Day 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 FMEAs 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.

 

Company Description
AgreeYa is a global systems integrator delivering competitive advantage for its customers through software, solutions, and services. Established in 1999. AgreeYa is headquartered in Folsom, California, with a global footprint and a team of more than 1,700 staff across offices. AgreeYa works with 500+ organizations ranging from Fortune 100 firms to small and large businesses across industries such as Telecom, BFSI, Healthcare, Utility, Technology, Public sector, Credit and Collections, Accounts Receivables Management and others

AgreeYa Solutions

Why Work Here?

Unlimited earning potential! Superior Benefits!

AgreeYa Solutions is a global Systems Integrator, delivering competitive advantage for its customers through software, solutions and services. Established in 1999, AgreeYa is headquartered in Folsom, California, with a global footprint and a team of more than 1700 staff across offices. AgreeYa works with 500+ organizations ranging from Fortune 100 firms to small and large businesses across industries such as Telecom, BFSI, Healthcare Utility, Technology, Public Sector, Credit and Collections, Account Receivables Management and others

Address

West Greenwich, RI
USA

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