Senior Specialist, Lead Investigator

Resilience-posted 3 months ago
$80,000 - $117,500/Yr
Full-time • Mid Level
Chemical Manufacturing
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The Senior Specialist, Lead Investigator is responsible for performing investigations and driving each event to conclusion by working with others. The Lead Investigator ensures the investigation outcome and root cause analysis are completed in a timely, effective, and compliant manner. The speed and rigor demonstrated by the Lead Investigator will drive a culture that prevents unplanned deviations through a robust and proactive investigation process.

  • 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, investigation strategy, investigation tools, action plan, root cause, solution selection, and CAPA action plan.
  • Utilizes the appropriate and approved investigation tools necessary to drive the team to root cause.
  • Prioritizes work to aid in timely decisions and completion of investigations.
  • Escalates issues as appropriate.
  • Completes other duties as assigned.
  • Experience in Pharmaceutical Manufacturing and/or other similar regulated industry.
  • Ability to quickly assess and assimilate technical data and conduct a thorough investigation.
  • Excellent written, verbal, and presentation skills.
  • Ability to monitor activities to accomplish stated objectives in an effective manner.
  • Ability to work in a fast-paced and rapidly changing environment.
  • Ability to prioritize work activities to meet customer needs and deadlines.
  • Ability to take accountability with excellent follow up and follow through.
  • Bachelor's degree required, preferably in Science, Engineering, or other related technical discipline.
  • Understanding of the internal core business process including relevant cGMP and regulatory.
  • Adept at identifying and understanding the critical factors in order to generate appropriate solutions.
  • Multiple site or function experience.
  • Experience with Quality Management Deviations.
  • Strong technical writing skills.
  • Familiar with Lean problem solving tools.
  • Proficiency with Microsoft Office Suite and have a working knowledge of computer systems such as Veeva, SAP, LIMS, and Electronic Batch Record Systems.
  • Annual cash bonus program
  • 401(k) plan with a generous company match
  • Healthcare benefits including medical, dental, and vision
  • Family building benefits
  • Life and disability insurance
  • Flexible time off
  • Paid holidays
  • Other paid leaves of absence
  • Tuition reimbursement
  • Support for caregiving needs
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