Cognate: QC Analyst I-BioAssay

Location: Memphis, TN

Pay Rate: $21.13–$24.50/hr.

Duration: 4 months

Schedule: Monday–Friday, 8:00 AM–4:30 PM; overtime as needed Training:1 month, Monday–Friday, 8:00 AM–5:00 PMJob Description Perform QC testing using cell-based immunological in vitro assays, including MLR, cytotoxicity, HLA-restriction, CTLp, and cell proliferation assays. Perform mammalian cell culture using aseptic techniques and established cell culture procedures. Execute molecular biology-based assays and laboratory testing according to approved methods and SOPs. Review QC test results for accuracy, precision, and compliance with established requirements. Perform study design, data analysis, statistical analysis, and preparation of written and oral test reports. Enter test observations and results into trending databases and support periodic data trending. Maintain QC laboratory inventories, testing logs, documentation, and records. Support laboratory investigations, including OOS and CAPA activities. Follow cGMP/GLP requirements, SOPs, and Good Documentation Practices to maintain data integrity and traceability. Education Bachelor’s degree in Biological Sciences or a related field preferred. 1–2 years of applicable laboratory, biotechnology, cell therapy, or related industry experience, or an equivalent combination of education and related work experience.

Required Skills: Cell-based immunological in vitro assays Mammalian cell culture Aseptic technique Cell proliferation assays Cytotoxicity assays MLR (Mixed Lymphocyte Reaction) HLA-restriction assays CTLp assays Molecular biology-based assays cGMP / 21 CFR 210 and 211 GLP Good Documentation Practices (GDP) SOP compliance QC testing and results review OOS investigations CAPA Data integrity and traceability Statistical/data analysis QC data trending

Preferred Skills: Biotech or cell therapy laboratory experience QC laboratory operations Experience with trending databases Laboratory documentation and product release testing Experience supporting quality improvement initiatives