Rochester, MN, 55905, USA
20 hours ago
QA Specialist
**Kelly Science & Clinical has a new, permanent opportunity for a QA Specialist in Rochester, MN!** **Shift:** M-F 8:00am-5:00pm **A Direct Hire Opportunity** **Salary:** $70k-$80k, DOE **Responsibilities:** + Implement QA strategies and support GxP inspection readiness. + Conduct audits on raw data and final reports for compliance with GxP, study protocols, and laboratory procedures. + Monitor and ensure laboratory quality assurance activities conform to policies and sound practices. + Review documentation for adherence to quality standards. + Ensure compliance of facilities, equipment, processes, and procedures with regulations and company standards. + Support change controls, deviations, investigations, CAPAs, and effectiveness checks. + Develop and maintain compliance-related metrics and reports. + Recommend necessary corrections and improvements. + Oversee personnel training record management. + Support internal and external audits. + Update Quality Assurance procedures and maintain QA records. **Qualifications:** + Bachelor's degree in quality assurance or a science-related field. + Minimum of 5 years of experience in a GxP or equivalent regulatory environment. + In-depth knowledge of GLP and GCP requirements. + Familiarity with ISO 9001, ISO 17025, and ISO 17034. + Experience with reviewing laboratory and computer validated data collection systems. + Understanding of regulations and scientific literature to ensure compliance. + Experience with quality process audits, deviations, and CAPA reviews. + Proficiency in Microsoft Office (Excel, Word, PowerPoint). + Strong time and project management skills. + Excellent interpersonal and communication skills. + Background in molecular biology, virology, and/or serology is a plus. + Experience with contract research organizations (CRO) and eQMS (Qualio) is a plus. **Benefits Offered:** + Paid Holidays + PTO + Health insurance + Dental/vision insurance + Life insurance + Employer paid short- and long-term disability + AD&D + Simple IRA with an employer match **Pay will be determined based on title, education, and related industry experience. If you, or someone you know would like to be considered for this opportunity, please apply online today to discuss the next steps.** 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 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. 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.
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