Quality Control Analyst

Job DescriptionThe QC CRS Analyst is responsible for conducting biochemical and testing of raw material, in-process, final product release and characterization samples, including CAR-T. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 5 -- 10 other Analysts within a functional Clinical Release and Stability Laboratory and report to the Senior QC Supervisor.Key Responsibilities:Conduct analytical biological testing of clinical and commercial drug product/drug substance samplesPerform peer reviews and approvals of laboratory dataUse electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing including application of statistical concepts to laboratory dataSupport of New Product Initiatives (NPI) including owning a project and perform project management functions with limited to no coaching from supervision/managementPerform Instrument Calibration and Preventative MaintenanceUpdate CRS-owned documents using the Document Management System (DMS)Order/receive supplies and manage inventorySupport analytical method qualification, validation, and transfer into and out of the QC lab, owning change control actions, completing testing activities with mentorship from Sr. Analysts on transfer activitiesComplete change control processes to integrate new methodologies and technologies into and out of the CRS Lab with limited oversightAct as a peer subject matter expert in assessing talent by participating in panel interviews for jobComplete invalid assay and general laboratory investigation recordsComplete corrective and preventative actions (CAPA) as assignedAssist in the execution of internal auditsRequired Skills & ExperienceMinimum one year of relevant GMP work experience in a lab settingBachelor degree in Biology or ChemistryWorking experience in a current Good Manufacturing Practices (cGMP) compliant QC laboratory or equivalent environment and solid understanding of cGMP and current Good Laboratory Practices (GLPs)Experience with one or more of the analytical technologies used in the Cell and Gene Therapy Laboratories such as qPCR, cell culture, Flow Cytometry, and/or ELISAAbility to read/interpret technical documents such as SOPs, work instructions, test methods and protocolsProficient with Microsoft Office applicationsNice to Have Skills & Experience1 year of experience working with mammalian cell cultureCAR-T, Cell and Gene Therapy, or Biochemistry laboratory experienceBasic knowledge of Compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QCAbility to complete equipment and software qualification protocolsExperience developing and setting long-term objectivesExperience working in Biosafety Level lab (BSL 2, BSL2+) or aseptic facilityKnowledge of EU/FDA guidanceCompensation:$32.00 - $47.00/hrExact compensation may vary based on several factors, including skills, experience, and education.Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Created: 2025-06-19