**Summary:** This is a direct hire full time position for a QC Manager, Microbiology in Winston Salem NC. This is an excellent opportunity to join a growing company and contribute to positive patient outcomes. **Location: Winston Salem NC** **Responsibilities:** + Manage the QC Microbiology testing programs and personnel, including overseeing daily operations and weekly testing schedules. + Collaborate with Product Development to ensure the timely completion of required sample testing. + Review and approve QC testing forms, ensuring compliance with protocols and regulatory standards. + Oversee the status changes of raw materials in the ERP system and issue raw materials for testing. + Serve as the subject matter expert for microbiology assays, providing guidance and troubleshooting assistance. + Ensure cGMP compliance within the department and represent QC during audits, inspections, and cross-functional project teams. + Write and review technical documents, protocols, and reports to maintain accuracy and clarity. + Lead daily operations in the lab and clean rooms, ensuring safety, quality, and compliance with all QC requirements. + Monitor and coach staff to ensure compliance with GMP and quality system standards. + Oversee the timely completion of document reviews for the on-time release of clinical lots. + Maintain quality control labs to ensure they are inspection-ready and well-maintained at all times. + Provide training and development for staff to ensure up-to-date knowledge and skills. + Perform additional duties as required. **Requirements:** + **Education/Training:** BS in Microbiology, Biology, or a related scientific discipline. + **Experience:** 7-10 years of relevant experience in a GMP setting, with previous supervisory experience preferred. + **Knowledge:** + Strong knowledge of GMP, FDA, and EMA regulatory requirements. + Familiarity with industry trends and the latest technologies in microbiology. + **Skills:** + Subject matter expert in quality control microbiology assays, including sterility testing and endotoxin testing. + Proficient in aseptic practices, clean room operations, and cGMP requirements. + Strong organizational, time management, and multitasking skills, with the ability to prioritize projects and meet deadlines. + Excellent problem-solving, decision-making, and critical thinking abilities. + Effective written and verbal communication skills for reporting and collaboration. + Experience with budget preparation, project facilitation, and employee training. 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.