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**Job Title:** Deviation Specialist (On-Site)

**Location:** Greenville, North Carolina

**Pay Rate:** $34/hour

Contract role

Job Summary:

The Deviation Specialist is responsible for the identification, documentation, investigation, and resolution of deviations from standard operating procedures, protocols, or regulatory requirements within a GMP-regulated environment. This role plays a key part in ensuring compliance with internal policies and external regulations by overseeing root cause investigations and implementation of corrective and preventive actions (CAPAs).

Key Responsibilities:

Deviation Management:

+ Identify, log, and manage deviations related to SOPs, quality standards, or regulatory requirements.

+ Lead investigations to determine root causes of deviations and product/process non-conformances.

+ Collaborate with cross-functional teams (e.g., QA, Manufacturing, Engineering) to ensure timely CAPA implementation.

Documentation and Reporting:

+ Maintain detailed, accurate records of all deviation investigations and CAPA activities.

+ Prepare and present deviation trend reports and investigation summaries to stakeholders.

+ Ensure all documentation complies with Good Documentation Practices (GDP).

Compliance and Quality Assurance:

+ Ensure deviation management aligns with internal SOPs, cGMP, and applicable regulatory standards.

+ Support internal and external audits, providing required documentation and explanations related to investigations.

Continuous Improvement:

+ Analyze deviation and CAPA trends to identify recurring issues and recommend improvements.

+ Contribute to initiatives that enhance product quality and operational efficiency.

+ Participate in relevant training and development activities to maintain technical knowledge.

Qualifications:

+ Bachelor’s degree in Life Sciences, Engineering, Quality, or a related field (preferred).

+ Minimum 2 years of experience in deviation management, QA, or quality systems in a pharmaceutical or GMP-regulated environment.

+ Solid understanding of FDA, EMA, and ISO regulatory frameworks.

+ Strong root cause analysis and technical writing skills.

+ Experience with QMS tools and electronic deviation tracking systems.

Preferred Qualifications:

+ Quality certification (e.g., Six Sigma, ASQ-CQE).

+ Familiarity with TrackWise or similar deviation/CAPA software.

+ Working knowledge of cGMP, GLP, and GDP principles.

Working Conditions:

+ This role requires presence in both office and GMP manufacturing areas.

+ May involve extended periods of standing or walking in a cleanroom environment.

+ Regular exposure to temperature changes, noise, and controlled manufacturing conditions.

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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) 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.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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.