Manufacturing Specialist - Cell Processing

Manufacturing Specialist III - Cell Processing Location: Winston Salem NC Contract Role, 12 month long with potential to convert Hourly Pay Rates: $32-$35/ hour Schedule: Monday-Friday 8am-5pm, with occasional overtime and weekend work required The Manufacturing Specialists III, Cell Processing plays a key role in supporting advanced manufacturing operations, focusing on cell processing activities and ensuring compliance with industry guidelines. This role involves operating and maintaining production equipment, performing critical product freezing and storage, and driving continuous improvement. The Manufacturing Specialist III is also responsible for mentoring team members, leading investigations, and maintaining high levels of quality and compliance. Essential Duties & Responsibilities: + Lead and oversee cell processing activities, ensuring compliance with industry standards and best practices. + Read, understand, and implement Standard Operating Procedures (SOPs) for all assigned tasks, providing guidance to team members. + Set up, operate, and troubleshoot production equipment, ensuring optimal performance and preventive maintenance. + Perform final freezing and storage of cell therapy products, ensuring adherence to procedures and maintaining quality standards. + Revise, update, and ensure adherence to SOPs, batch records, and related forms, maintaining compliance with regulatory guidelines. + Lead routine cycle counts and ensure accurate inventory tracking and control. + Execute transactions within an ERP system, including material requisitions and production tracking. + Ensure accuracy of documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices (GDP). + Lead investigations into deviations and Corrective and Preventive Action (CAPA) efforts, compiling data and information as needed. + Provide mentorship and training to junior team members in cell processing techniques, procedures, and regulatory compliance. + Drive continuous process improvement, incident investigations, and deviation resolutions. + Ensure all activities comply with safety policies, rules, and regulations, promoting a safe working environment. + Conduct aseptic manufacturing processes in a controlled environment, ensuring compliance with sterile techniques and regulatory standards Key Responsibilities: + Lead and perform cell processing activities in compliance with cGMP guidelines and internal manufacturing protocols. + Interpret and implement Standard Operating Procedures (SOPs) and provide guidance and training to junior staff. + Operate and maintain manufacturing equipment, including control rate freezers and orbital shakers. + Execute final product freezing and storage in liquid nitrogen (LN2) systems while ensuring adherence to quality and safety standards. + Review and revise GMP documentation such as SOPs, batch records, and forms to ensure compliance and accuracy. + Oversee inventory control tasks including routine cycle counts and ERP system transactions (e.g., requisitions, production entries). + Ensure thorough and accurate documentation of all activities in compliance with Good Documentation Practices (GDP). + Lead or support investigations related to deviations and corrective/preventive actions (CAPAs). + Provide mentorship, training, and technical support to less experienced personnel in the lab or cleanroom. + Contribute to continuous improvement initiatives, including incident investigations and procedural enhancements. + Perform aseptic processes in a cleanroom environment following sterile technique and regulatory standards. + Assist with incoming material qualification testing and lot release evaluations. + Support process development, validation activities, and data collection for process optimization and regulatory documentation. + Maintain adherence to all safety protocols and promote a culture of workplace safety. Qualifications: + Associateu2019s or Bacheloru2019s degree in Biotechnology, Biology, Chemistry, or related field preferred. Significant relevant experience may be considered in lieu of formal education. + 4u20136 years of hands-on experience in a biotechnology or cell therapy manufacturing setting, including at least 2u20133 years in a cGMP-regulated environment. + Strong ability to lead by example, troubleshoot processes, and uphold cGMP and aseptic standards. + Experience operating manufacturing equipment and conducting cleanroom processes under sterile conditions. + Familiarity with ERP systems and strong proficiency in Microsoft Office (Excel, Word, Outlook). + Excellent organizational, communication, and problem-solving skills, with an ability to work independently or as part of a team. 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 u00ae 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 worldu2019s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsu2014itu2019s 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, weu2019re obsessed with where it can take you. To us, itu2019s about more than simply accepting your next job opportunity. Itu2019s the fuel that powers every next step of your life. Itu2019s 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 lifeu2014just 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 Californiau2019s 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 Kellyu2019s Human Resource Knowledge Center. Kelly complies with the requirements of Californiau2019s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Created: 2026-01-14