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Quality Assurance Supervisor-Rochester, MN

Kelly Science & Clinical is seeking a Quality Assurance Supervisor for one of our clients, a pharmaceutical manufacturer, in Rochester, MN. The overall responsibility of this role is to oversee the Quality Assurance (QA) team, manage day-to-day operations, support quality-related initiatives, and provide guidance to cross-functional teams,. This role focuses on managing quality systems, ensuring product quality, developing quality team members, and driving continuous improvement initiatives across the organization.

ESSENTIAL JOB FUNCTIONS

+ Supervisor and mentor QA team members, fostering accountability, compliance, and continuous improvement

+ Oversee QA training, ensuring employees are equipped with GMP and the necessary skills

+ Set performance objectives for the QA team and provide regular feedback and performance evaluations

+ Provide QA oversight of quality events, deviations, CAPAs, and OOS Phase II investigations, make key decisions on product quality, compliance, and regulatory conformance, and escalate significant risks to leadership

+ Oversight of customer complaint handling

+ Review and/or approve methods, procedures, master records, executed records, reports, and protocols employed in the conduct of cGMP activities

+ Support planning and execution of internal audits, external audits, regulatory inspections, and supplier audits by preparing documentation, maintaining records, and tracking responses to findings.

+ Assist in maintaining a Supplier Management Program

+ Contribute to the Quality Management System (QMS) by developing, implementing, and continuously improving SOPs, training programs, and systems

REQUIRED EDUCATION/EXPERIENCE

+ Bachelor’s degree in a science discipline

+ At least 5+ years in a QA function within the pharmaceutical industry, including 2+ years of experience in a leadership role

+ Knowledge of cGMPs or quality regulations, including 21 CFR 211 required

+ Strong leadership abilities with experience mentoring and developing teams

+ Previous experience leading inspection readiness and audits

+ Strong knowledge of quality systems, deviation/investigation management, risk assessment, and regulatory compliance expectations

This is a Direct Hire position with pay commensurate upon applicable education and experience. If you feel you meet the above qualifications, please submit your resume for immediate consideration. #P1

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.