QA Specialist

• Kelly Science & Clinical has a direct hire opportunity for a
• QA Specialist
• in Rochester, MN!
• A Direct Hire Opportunity

• Salary Range:

• $75,000-$95,000
• M-F 8am-5pm

• Summary:

• Seeking a detail-oriented QA Specialist to strengthen laboratory quality and data integrity programs in a biotech/CRO environment. Responsible for ensuring regulatory compliance, robust data practices, method validation oversight, and cross-functional project support.

• Key Responsibilities:

• + Serve as SME for data integrity and Good Documentation Practices, conducting audits and training staff + Oversee and review assay qualification/validation studies and documentation + Support analytical method transfers, review protocols, and ensure scientific rigor + Act as QA liaison on project teams and manage QA deliverables and timelines + Participate in lab management activities including audits, deviation investigations, and equipment qualification + Maintain and improve SOPs, quality indicators, and inspection readiness •

Qualifications:

• + Bachelor's degree in Life Sciences or related field (Master's preferred) + 3-5+ years of QA experience in a regulated laboratory setting + Hands-on experience in GCLP or GLP-regulated biotech/CRO environment + Expertise in at least three: data integrity, assay validation, sample management, method transfer, or lab QA + Knowledge of

ALCOA+, FDA 21 CFR

Part 11, ICH Q2(R1), and related regulations + Experience with

LIMS/ELN

; proficiency with Microsoft Office and eQMS platforms

• Compensation and benefits:
• Salary is commensurate with experience and qualifications.

A comprehensive benefits package including:

+ 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 + Annual bonus

• Salary will range between $75k-$95k based on education, title, and related experience. If you, or someone you know, would like to be considered 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 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.