Job Description

Are you experienced in Deviation remediation? Kelly Scientific is searching for a Lead Investigator 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 months

• Rate: $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.

REQUIREMENTS

Minimum :

• 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

Preferred :

• 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

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. 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. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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