Quality Control Analyst

Monday through Friday, 8:00 AM to 4:30 PM Overtime as needed Training/orientation for approximately 1 month on day shift, Monday through Friday, 8:00 AM to 5:00 PM Interview Process Virtual interview Responsibilities Perform cell based immunological in vitro methods such as MLR, cytotoxicity, HLA restriction, CTLp, cell proliferation, and related techniques using laboratory instrumentation. Follow cGMP/GLP regulations and maintain accurate, thorough documentation to support Quality Control activities. Review QC test results for accuracy and precision while maintaining efficient workflow and ensuring timely submission of testing documentation for product release. Support study design, data and statistical analysis, and communicate results through written reports and presentations. Enter observations and results into trending databases for periodic analysis and trending. Perform aseptic techniques and culture mammalian cells. Assist with maintaining QC laboratory operations, including inventories, logs, documentation, and filing. Support implementation of quality improvement initiatives within the QC laboratory. Participate in laboratory investigations, including OOS, CAPA, and other quality investigations as required. Follow Standard Operating Procedures (SOPs) and Good Documentation Practices to ensure data integrity and traceability. Perform other related duties as assigned. Qualifications Bachelor's degree in Biological Sciences or a related field preferred. 1 to 2 years of laboratory, biotechnology, cell therapy, or related industry experience, or a combination of 1 to 2 years of education and related work experience. Experience with aseptic technique and culturing mammalian cells. Familiarity with cGMP regulations as defined in 21 CFR 210 and 211. Experience with cell based assays and molecular biology based assays. Strong attention to detail with excellent written and verbal communication skills. Ability to work independently and collaboratively as part of a team. #J-18808-Ljbffr