UTS-Temporary Quality Control Analyst at UNC Chapel Hill

Position Overview The Quality Control Analyst is responsible for performing and supporting Quality Control testing activities related to sterility, bioburden, release testing, stability testing, and analytical development. This role executes laboratory testing procedures, analytical validations, and data review activities to support the manufacturing and release of patient products while ensuring compliance with FDA requirements, Good Documentation Practices (GDP), and established quality standards. The analyst supports new product onboarding, develops and maintains testing procedures, assists with investigations, performs statistical analysis of results, and provides guidance and training to QC employees on testing methods and processes. Responsibilities Perform and support QC testing activities related to sterility, bioburden, release testing, stability testing, and analytical development. Execute laboratory testing procedures, analytical validations, and data review activities to support manufacturing and release of patient products, ensuring compliance with FDA requirements, GDP, and quality standards. Support new product onboarding, develop and maintain testing procedures, assist with investigations, perform statistical analysis of results, and provide guidance and training to QC employees on testing methods and processes. Qualifications Bachelor’s degree in Biology, Microbiology, Biotechnology, Biochemistry, Chemistry, Life Sciences, or a related scientific discipline with laboratory experience in quality control, analytical testing, or a regulated manufacturing environment. Equivalent combination of education and relevant laboratory experience may be considered. Experience performing laboratory testing and following established analytical procedures. Knowledge of quality control processes, documentation practices, and regulated laboratory environments. Ability to perform sterility and bioburden testing using applicable laboratory systems and techniques. Familiarity with analytical testing methods including PCR, flow cytometry, endotoxin testing, and microbial testing. Ability to accurately document test results in accordance with GDP and quality standards. Ability to review analytical data, identify trends, and support investigations. Strong attention to detail, organizational skills, and ability to maintain accurate records. Ability to prepare, review, and revise SOPs, forms, job aids, and technical documentation. Ability to collaborate with Quality, Manufacturing, and Laboratory teams. Participate in 5 hours of continuing education annually in cellular therapy or quality topics. 2+ years of experience in Quality Control, biotechnology, pharmaceutical, cellular therapy, or life sciences laboratory settings. Experience working in GMP or FDA-regulated environments. Experience with sterility testing, bioburden testing, and analytical method validation. Experience supporting product release and stability testing programs. Experience with BacT/ ALERT Sterility System or similar microbial testing platforms. Experience with laboratory investigations, data analysis, and quality documentation. Experience training or mentoring team members on laboratory procedures and testing methods. Knowledge of cellular therapy manufacturing processes and quality systems preferred. Work Schedule Monday‑Friday, 8 AM – 5 PM NC State University is an equal‑opportunity employer. All qualified applicants will receive equal opportunities for employment without regard to age, color, disability, gender identity, genetic information, national origin, race, religion, sex (including pregnancy), sexual orientation, and veteran status. Individuals with disabilities requiring accommodations in the application and interview process are welcome to contact the Office of Equal Opportunity at View phone number on click.appcast.io. #J-18808-Ljbffr