Deviation Management Specialist

West Point, Pennsylvania

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Deviation Management Specialist

Contract: West Point, Pennsylvania, US

Salary: $41.00 Per Hour

Job Code: 350824

End Date: 2024-07-18
Days Left: 28 days, 3 hours left

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About the Role:
  • We are seeking a motivated and detail-oriented individual to join our team as a Technical Support Specialist in the pharmaceutical/biotech industry.
  • The ideal candidate will have a background in engineering or a scientific field and experience working in a cGMP environment.
  • This role will involve providing technical support to manufacturing operations, investigating process deviations, and implementing corrective actions.

Responsibilities:
  • Provide day-to-day technical support to manufacturing operations
  • Resolve and reduce process deviations
  • Develop and implement corrective/preventative actions
  • Lead manufacturing and laboratory investigations
  • Develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release
  • Utilize scientific and engineering principles to investigate process deviations
  • Troubleshoot and conduct root cause analysis of laboratory test failures and manufacturing atypical events
  • Develop corrective/preventative actions
  • Analyze complex problems through critical analytical thinking
  • Design and execute laboratory/pilot scale experiments
  • May require off-shift work

Education Qualification:
  • B.S./M.S. degree in appropriate engineering/scientific field

Required Skills:
  • 0-3 years post-Bachelors degree experience in a cGMP environment
  • Experience in writing investigations for atypical events in a manufacturing environment
  • Familiarity with Lean Six Sigma Methodologies
  • Proven analytical and problem-solving capabilities
  • Ability to work independently and as part of a cross-functional team
  • Excellent written and verbal communication skills

Job Requirement
  • cGMP
  • investigations
  • investigation writing
  • Lean Six Sigma
  • scientific
  • root cause analysis
  • laboratory investigations
  • manufacturing operations
  • CAPA
  • corrective/preventative actions
  • aseptic
  • aseptic manufacturing
  • JobsPA
  • Westpointjobs
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Rohan Lazarus

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Date Posted: 22 June 2024
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