Lead Investigator Job at Kelly Science, Engineering, Technology & Telecom, West Chester, Butler County, OH

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  • Kelly Science, Engineering, Technology & Telecom
  • West Chester, Butler County, OH

Job Description

Are you experienced in Deviation remediation? Kelly Scientific is searching for multiple Lead Investigators with Pharma Manufacturing experience to work on non-critical deviations. These are 6 month contract roles with full benefits provided.

  • Title: Lead Investigator
  • Location: Cincinnati, OH (hybrid)
  • Length of Assignment: 6-12 months
  • Rate: $40-43/hr. w/ benefits provided (PTO, insurance, etc.)

  • Responsibilities :Conducts organized investigations with a well-defined scope, strategy, and timeline documenting status and progress of the investigation.
  • Authors reports that document the investigation of issues including definition, scope, product impact, root cause, and corrective actions to prevent the recurrence of the issue.
  • Seeks and leverages the skills and technical expertise of internal and external resources to improve the speed and rigor of investigations.
  • Collaborates with a cross functional team to determine:
  • Communication strategy so all stakeholders have appropriate information.
  • Investigation strategy including a clear and actionable problem statement.
  • Investigation tools.
  • Investigation action plan and timing.
  • Root cause.
  • Solution selection.
  • CAPA action plan and effectiveness checks.
  • Prioritizes work to aid in timely decisions and completion of investigations. Escalates issues as appropriate.
  • Completes other duties as assigned.

REQUIREMENTS

  • Minimum :Ability to quickly assess and assimilate technical data and conduct a thorough investigation
  • Ability to present findings, conclusions, and complex information in a clear, concise, and logical manner.
  • Excellent written and verbal communication skills, including technical writing capability.
  • Ability to work in a fast-paced and rapidly changing environment.
  • Ability to take accountability with excellent follow through, showing ownership through the full investigation process.
  • Proficiency with Microsoft Office Suite and have a working knowledge, or the ability to learn, QMS systems such as Veeva

  • Preferred :Experience in Pharmaceutical Manufacturing or other similar regulated industry.
  • Familiarity with problem-solving tools.
  • Understanding of the internal core business process including relevant cGMP and regulatory.
  • Bachelor’s degree, preferably in Science, Engineering, or other related technical discipline.
  • Experience in Quality Deviation Management

Job Tags

Contract work,

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