Quality Assurance Specialist, Cell Therapy

Quality Assurance Specialist Kellyu00ae Science & Clinical is seeking a Quality Assurance Specialist for a 6-month contract position at a cutting-edge biotech company in South San Francisco, CA . If youu2019re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts. Pay Rate: $40-42/hour Overview: In this role, you'll be responsible for providing hands-on QA support on the production floor, including reviewing validation documents and production records, investigating deviations, and ensuring compliance with GMP standards. You will be part of an innovative team dedicated to advancing cell therapy manufacturing, where your contributions help uphold rigorous quality standards as the organization grows. Schedule: Monday-Friday, Standard Working Hours Responsibilities: + Provide Quality Assurance (QA) support for daily manufacturing operations, ensuring all activities comply with approved SOPs and cGMP/cGxP requirements. + Review executed batch records, logbooks, and production documentation for completeness, accuracy, and adherence to regulatory standards. + Take primary responsibility for reviewing validation documents, such as user requirements, testing protocols, and reports from lab equipment or facility qualifications, to confirm compliance and accuracy. + Participate in the investigation and documentation of deviations by assisting with root cause analysis and supporting timely closure of quality events. + Assist in the release of materials and ensure readiness and proper documentation for product shipping and release. + Conduct routine QA walkthroughs on the manufacturing floor, actively monitoring and escalating any quality events or non-compliance issues. + Support document control processes, including the review, routing, and management of SOPs and participation in change control activities for both operational and documentation updates. + Collaborate daily with cross-functional teams such as Manufacturing, Warehouse, and Quality Control. + Use TrackWise Digital, LabVantage, and SAP, to ensure all activities meet GDP and regulatory expectations. + Other duties as assigned. Qualifications: + Bacheloru2019s degree in Science or related field required. + 1+ years of experience in QA in a regulated industry (e.g., medical devices, pharmaceuticals, cell & gene therapy _preferred_ ). + Working experience with cGMP principles and regulatory requirements (FDA, EMA, ICH). + Familiarity with TrackWise Digital electronic QMS, LabVantage, and SAP. What happens next: Once you apply, youu2019ll proceed to next steps if your skills and experience look like a good fit. But donu2019t worry u2013 even if this position doesnu2019t work out, youu2019re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless. 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: 2026-04-08