Lead Investigator

Are you experienced in Deviation remediation? Kelly Scientific is searching for multipleLead 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 monthsRate: $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.REQUIREMENTSMinimum:Ability to quickly assess and assimilate technical data and conduct a thorough investigationAbility 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 VeevaPreferred: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

Created: 2025-02-15