Investigator, Manufacturing Compliance Job Listing at Kelly Services in Greensboro, NC (Job ID 9784727)

Description

Position Title: Investigator, Manufacturing Compliance (Contract)
Location: Winston-Salem, NC

Position Summary:
The Investigator is responsible for maintaining quality systems and ensuring cGMP compliance by verifying that all team members follow established processes, procedures, and instructions. The role requires adherence to safety policies, rules, and regulations while ensuring team compliance in all activities.

The Investigator leads the initiation, investigation, and resolution of process deviations, Change Controls, and CAPAs. This includes identifying root causes, assessing product quality impact, and implementing corrective actions to prevent recurrence. The role also involves drafting and managing departmental Change Controls.

Responsibilities:

• Translate moderate to complex scientific events into clear, concise reports suitable for internal and external stakeholders. Capture immediate actions, containment measures, and address review comments effectively.

• Gather data from multiple sources, perform Root Cause Analysis, assess impact on safety, identity, strength, quality, and purity, and recommend corrective and preventive actions to minimize deviation recurrence.

• Conduct trending analysis, risk assessments, and cause mapping, including interviewing relevant personnel.

• Manage multiple investigations and timelines concurrently, escalating issues as necessary to meet deadlines.

• Collaborate with departments to observe processes, collect data, and conduct interviews to support investigations.

• Facilitate meetings with internal teams and subject matter experts, ensuring alignment on investigational approach and achieving objectives efficiently.

• Maintain awareness of regulatory requirements related to cell therapy processing.

• Lead and track Change Controls through completion, ensuring timely resolution.

• Perform additional duties as assigned.

Qualifications:

• Bachelor's degree in a scientific discipline.

• 5+ years of experience in a cell therapy or related cGMP-regulated environment.

• Strong organizational skills and attention to detail, with excellent record-keeping abilities.

• Experience interviewing staff to gather relevant investigation information.

• Effective written and oral communication skills.

• Independent, self-motivated, and able to work overtime when necessary.

• Familiarity with cGMP quality systems and ability to read SOPs, logs, and batch records.

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and strong typing skills.

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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