What are the responsibilities and job description for the Quality Assurance Auditor – GCP /R&D position at Kelly Science, Engineering, Technology & Telecom?
Overview
This role supports animal health research and development by providing quality oversight and consultative support across clinical and non-clinical activities. The position is heavily focused on Good Clinical Practice (GCP) auditing of veterinary clinical sites, with additional responsibilities supporting internal lab/process audits and regulatory inspection readiness. This individual will play a key role in hosting FDA inspections and ensuring compliance across R&D operations.
Key Responsibilities
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.
This role supports animal health research and development by providing quality oversight and consultative support across clinical and non-clinical activities. The position is heavily focused on Good Clinical Practice (GCP) auditing of veterinary clinical sites, with additional responsibilities supporting internal lab/process audits and regulatory inspection readiness. This individual will play a key role in hosting FDA inspections and ensuring compliance across R&D operations.
Key Responsibilities
- Plan and conduct GCP audit activities for veterinary clinical studies (e.g., protocol, in-life, data, and final report audits) in alignment with VICH and applicable regulatory standards
- Provide sponsor oversight for outsourced studies, including third-party vendor audits and review of study deliverables
- Support GLP compliance through protocol and final report reviews for non-clinical safety studies conducted externally
- Prepare, issue, and follow up on audit reports, observations, and corrective/preventive actions
- Conduct internal process audits (e.g., data management, archiving, monitoring, quality systems)
- Lead and coordinate inspection readiness activities and host regulatory inspections (including FDA) at R&D headquarters and clinical sites
- Deliver training on quality and regulatory compliance topics; develop training materials as needed
- Provide quality oversight of site quality systems and contribute to procedural development
- Partner cross-functionally with R&D, quality, and external stakeholders to ensure compliance with global regulatory requirements
- Escalate risks and compliance issues appropriately and provide strategic quality guidance
- Bachelor’s degree in life sciences (e.g., biology, animal science, pharmacy) required; advanced degree preferred
- 10 years of experience in GCP and/or GLP quality assurance within animal health, pharmaceutical, or related industries
- Strong experience auditing veterinary clinical studies and supporting regulatory submissions (FDA, USDA, EPA)
- Demonstrated experience hosting or supporting regulatory inspections
- Proven ability to deliver compliance training and influence cross-functional stakeholders
- Solid understanding of quality systems, risk assessment, and regulatory frameworks
- Experience with computer system validation is a plus
- RQAP-GLP certification
- Experience with IACUC, biosafety, or health and safety programs
- Deep expertise in GCP auditing with the ability to operate independently
- Strong communication and stakeholder management skills
- A proactive, service-oriented approach to quality that enables and guides the business
- Confidence in leading inspection readiness and interacting with regulatory authorities
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.