
Description
Quality Assurance Auditor
Location: Lancaster, South Carolina
Schedule: Monday-Friday 8:30am-5pm
Salary: $110,000-$125,000/year with a discretionary bonus potential work up to 12-15% of YTD earnings
Position Summary
The Quality Assurance Auditor plays a key role in supporting and maintaining internal compliance programs to ensure alignment with relevant regulations and industry standards. This position involves planning and conducting internal and external audits, coordinating corrective actions, and supporting supplier qualification processes.
Key Responsibilities-
Plan, schedule, and conduct audits (both internal and external) to assess compliance with applicable regulatory requirements.
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Oversee aspects of the vendor qualification program, including maintaining approved supplier documentation and records within a digital quality management system.
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Coordinate with third-party audit providers for international supplier assessments, as needed.
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Manage corrective action request programs related to supplier and audit findings.
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Maintain and organize documentation related to audits, vendors, and compliance activities in the quality system.
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Evaluate audit findings, determine risk levels, and monitor the implementation of corrective and preventive actions.
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Develop and track key performance indicators to monitor audit and compliance effectiveness.
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Assist in the implementation of corrective and preventive actions (CAPAs) across departments when needed.
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Support training initiatives to enhance compliance awareness across internal teams.
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Identify and assess potential areas of internal non-compliance, and contribute to process improvement or policy development.
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Assist in preparation for regulatory inspections and internal readiness initiatives.
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Collaborate with various departments to support quality and compliance functions across operations.
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Participate in audit-related reporting and present key audit metrics to quality leadership.
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Provide quality oversight and input on supplier-related investigations, product development activities, and CAPAs.
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Utilize enterprise systems such as SAP and other compliance software.
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Perform additional duties in support of overall quality and compliance goals.
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At least 5 years of auditing experience in a cGMP-regulated environment.
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Minimum of 5 years of experience performing external supplier or vendor audits within a regulated industry.
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Familiarity with regulatory requirements such as 21 CFR Parts 210, 211, 507, and 111 (or equivalent standards).
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Certification as a Quality Auditor (e.g., ASQ CQA) is preferred.
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Strong computer skills, including experience with common business software and digital quality systems.
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Ability to perform audits in various environments including manufacturing and cleanroom settings, with appropriate use of PPE.
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Willingness and ability to travel (approximately 20–30%), with potential for occasional international travel depending on business needs.
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Bachelor's degree in a science or technical field is required plus 5 years of auditing experience
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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