Lead Investigator

Join Our Team as a Lead Investigator!

Are you experienced in Deviation Remediation with a passion for improving Pharma Manufacturing processes? Kelly Scientific is excited to offer a Lead Investigator position for individuals like you to work on non-critical deviations in a dynamic and supportive environment. This is a 6-12 month contract role that includes the opportunity to contribute to impactful projects in the pharmaceutical industry.

Title: Lead Investigator

Location: Cincinnati, OH

Contract Duration: 6 months minimum (1 year anticipated)

Compensation: $32-$36/hour

What You’ll Do:

• Take charge of detailed investigations with a clear scope, strategy, and timeline while keeping stakeholders updated on progress and status.
• Write impactful reports that document your findings on product impact, root cause analysis, corrective actions, and preventive measures to ensure issues don’t recur.
• Collaborate with internal and external experts to enhance the speed and quality of investigations.
• Work closely with cross-functional teams to:
• Develop a clear communication strategy to ensure stakeholders are well-informed.
• Design actionable investigation plans, including defining problems and solutions.
• Identify root causes and implement effective CAPA action plans with follow-up checks.
• Manage priorities to ensure investigations are completed in a timely manner, escalating issues as needed.
• Tackle new challenges and contribute to process improvements across the organization.

What We Need From You:

• Required:
• Strong technical analysis skills with the ability to assess and quickly assimilate complex data to conduct thorough investigations.
• Excellent communication skills to present findings and recommendations in a concise and effective manner.
• Ability to work efficiently in a fast-paced, rapidly changing environment.
• Proactive approach with a strong sense of accountability and ownership throughout the investigation process.
• Proficiency in Microsoft Office Suite and a willingness to learn QMS systems such as Veeva.
• Preferred:
• Background in Pharmaceutical Manufacturing or other regulated industries.
• Familiarity with problem-solving tools and techniques.
• Understanding of core business processes, including cGMP and regulatory requirements.
• A Bachelor’s degree in Science, Engineering, or a related technical field.
• Experience in Quality Deviation Management.

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