Lead Investigator - Pharmaceuticals

About the role

Kelly Scientific is seeking a Lead Investigator to work on non-critical deviation remediation in pharmaceutical manufacturing. This is a 6-12 month contract position based in Cincinnati, OH.

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 documenting 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 ensuring 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.

Required Qualifications

• 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 Qualifications

• 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.

Benefits

Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. Employees also have access to a retirement savings plan, service bonus and holiday pay plans (up to eight paid holidays per benefit year), and a transit spending account. Paid sick leave is available under applicable state or local plans.