Quality Control Analyst II

Responsible for performing and reviewing routine analytical testing of various sample types, including raw materials, intermediates, and drug substance/products to ensure compliance with GMP standards and product specifications. This QC Analyst II position requires team-coordinated work, combined with exercising more independent efforts to troubleshoot methods, support method qualifications, and investigations pertaining to OOS/OOT findings. Increased efforts in document writing and supporting operational aspects of QC team is an important function of this position. Supervisory Responsibilities None Duties and Responsibilities Execute and troubleshoot analytical methods including potency assays, qPCR/dPCR, ELISA, and/or flow cytometry. Review and interpret analytical data, ensuring accuracy, traceability, and compliance. Assist in method qualification, sample management, and stability testing. Support OOS/OOT investigations, deviations, and CAPA implementation. Train junior analysts and maintain laboratory readiness for audits. Contribute to continuous improvement and process efficiency projects. Additional duties as assigned. Education and Experience Requirements A Bachelor’s degree in a science related field. 2-5 years of industry experience in biologics, vaccines, cell/gene therapy, or a similarly relevant area, utilizing a defined QMS. Required Skills and/or Qualifications Well versed in aseptic technique, molecular biology assays, cell-based potency assay, and/or biochemical/protein assays. Familiarity with data integrity principles and electronic systems (LIMS, ELN). Should be detail-oriented and have the ability to work independently and productively under general direction, routinely exercise initiative and sound judgment to contribute to team objectives. Able to assist in the authorship of complex protocols and reports, and/or quality programs Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities. Physical Requirements Prolonged periods of sitting at a desk and working on a computer. Job Type Weekends or weeknight work is occasionally required depending on the production schedule or process needs. Group Healthcare Plan, including company paid dental and vision. Short- and long-term disability, life and AD&G insurance. #J-18808-Ljbffr