Quality Assurance Lead Investigator – Sharonville, OH

Kelly Scientific is searching for Lead Investigators with Pharma Manufacturing Quality experience to work on non-critical deviations.

• Title: Lead Investigator
• Location: Sharonville, Ohio Area
• Length of Assignment: 6-12 months
• Rate: $40-43/hr. with full 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:

• Bachelor’s degree, preferably in Science, Engineering, or other related technical discipline.
• Experience in Quality Deviation Management
• 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.
• 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