Lead Investigator Job Listing at Kelly Services in Cincinnati, OH (Job ID US3557370_BH9802791)

Description

Kelly Scientific is partnering with an established biopharma CDMO to identify a Lead Investigator. The Lead Investigator ensures the investigation outcome and root cause analysis are completed in a timely, effective, and compliant manner, and documents the investigation clearly and concisely so as to be presentable to a regulatory inspector.
 

• Title: Lead Investigator
• Location: Cincinnati, OH metro area
• Hybrid schedule: 3 days onsite and 2 days off
• Duration: 6-12 months
• Rate: $38-43/hour + full benefits

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.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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