Quality Assurance Auditor

Quality Assurance Auditor Location: Lancaster, SC Shift: Monday – Friday | 1st Shift Salary: $70,000-$95,000/year + Annual Bonus Opportunity We are seeking a Quality Assurance Auditor to develop and maintain an effective internal compliance program to support adherence to applicable regulations and quality standards. This role plans and conducts internal and external audits, manages supplier audit activities and corrective actions, and works with teams across the organization to strengthen compliance and inspection readiness. What You'll Do Plan, schedule, and conduct internal and external audits to assess compliance with applicable regulations and quality requirements.Audit external suppliers, contract manufacturers, laboratories, and other service providers; maintain the supplier qualification program and Approved Vendor List in the quality management system.Coordinate external providers supporting international audits.Manage the supplier corrective action request (SCAR) program, assess the risk and significance of audit findings, and follow up to ensure corrective and preventive actions are appropriate and effective.Maintain audit, supplier, and vendor documentation in the quality management system.Track and report audit and compliance metrics; prioritize work to ensure audits, reports, and corrective actions are completed on time.Identify areas of potential noncompliance and support development or implementation of processes and policies to reduce risk.Support CAPA activities, regulatory inspection readiness, and training for internal teams on quality and compliance expectations.Provide Quality Assurance support for contract manufacturing activities, including product development, investigations, and CAPAs, as needed.Collaborate with Quality Assurance colleagues and teams across the organization.Perform other duties as assigned in support of Quality Assurance and company objectives. Required Qualifications Bachelor’s degree in a science or technical field.5+ years of Quality Assurance auditing experience in a cGMP environment, including at least five years of external supplier or vendor compliance auditing experience in an FDA-regulated industry.Experience conducting both internal and external audits.Working knowledge of 21 CFR Parts 210, 211, and 507, as well as dietary supplement regulations under 21 CFR Part 111.Flexibility to travel to supplier sites, sometimes with limited notice.Proficiency with Microsoft Office applications. Preferred Qualifications ASQ Certified Quality Auditor (CQA) certification.Familiarity with SAP and quality management systems. Work Authorization Candidates must be authorized to work in the United States without employer sponsorship now or in the future. Physical Requirements The role may require standing, walking, pushing, and pulling in manufacturing and clean-room environments, as well as wearing personal protective equipment appropriate to the audit setting. Compensation & Benefits Competitive salary based on experience.Eligible for an annual performance bonus (up to 12% of annual earnings, based on company performance).Comprehensive benefits package including medical, dental, vision, 401(k), paid time off, and career development opportunities. As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. 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. Kelly may use AI-powered tools during the recruitment and hiring process. 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