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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