A Quality Control Analyst, in the biotech and medical device industries, works in laboratories performing biological, microbiological, and chemical tests on products and materials. Responsible for calibrating equipment, inspecting products, processing and testing materials, and reporting results. May work in other production environments to monitor and improve quality and efficiency in production systems and products.
Virtual Job Summary We are seeking a QC BioAssay Analyst I / II to support Quality Control laboratory operations in a fast-paced, highly technical environment. The ideal candidate will have strong attention to detail, excellent organizational and communication skills, computer proficiency, and experience with laboratory instrumentation and cell-based assays. Key Responsibilities Perform and support cell-based immunological in vitro methods , including MLR, cytotoxicity, HLA-restriction, CTLp, and cell proliferation assays. Work with laboratory instrumentation and maintain accurate test results and documentation. Review QC test results for accuracy and precision. Follow cGMP/GLP requirements , SOPs, and good documentation practices. Perform study design, data/statistical analysis, and reporting of results. Enter observations and results into appropriate trending databases. Perform aseptic techniques and mammalian cell culture procedures. Maintain laboratory inventories, logs, documentation, and filing systems. Support quality improvement initiatives within QC laboratory operations. Participate in laboratory, OOS, CAPA, and other investigations as required. Maintain data integrity, traceability, and timely completion of required documentation. Perform other related duties as assigned. Qualifications Bachelor's degree in Biological Sciences or a related field preferred . Minimum 1-2 years of applicable laboratory, biotech, cell therapy, or related industry experience , or a combination of education and related work experience. Experience with aseptic techniques and mammalian cell culture . Familiarity with cGMP regulations , including 21 CFR 210 and 211. Experience with cell-based assays and molecular biology-based assays . Strong attention to detail and organizational skills. Excellent written and verbal communication skills. Ability to work independently as well as collaboratively within a team. Basic understanding of laboratory instrumentation and strong computer skills. Training Approximately 1 month of training/orientation on day shift, Monday-Friday, 8:00 AM-5:00 PM . After training, the regular schedule will be Monday-Friday, 8:00 AM-4:30 PM , with overtime as needed.
Pay:
$20.00 - $25.00 per hour Application Question(s): Do you have minimum 1-2 years of applicable laboratory, biotech, cell therapy, or related industry experience? Do you have experience with aseptic techniques and mammalian cell culture? Are you familiarity with cGMP regulations, including 21 CFR 210 and 211? Do you have experience with cell-based assays and molecular biology-based assays? Do you have bachelor's degree in Biological Sciences or a related field?
