Quality Control Scientist

About the RoleReporting to the Director of Quality Control, the QC Scientist will be responsible for the development, execution, and analysis of flow cytometry assays. Familiarity with additional testing modalities, including ELISA-based assays, is required to provide quality oversight of manufacturing and Quality Control activities, such as in-process and final product testing, to ensure results meet defined specifications prior to release. All assay development and execution must comply with cGMP regulations and internal Standard Operating Procedures (SOPs). This role requires extensive experience with bioanalytical assays and a strong working knowledge of GMP requirements for late-stage and commercial cell therapy products in the United States.ResponsibilitiesCoordinate and perform cGMP-compliant testing for product release, in-process controls, and stability samplesEnsure QC equipment is properly qualified, maintained, and calibrated in accordance with GMP requirements.Prepare, execute, and document technology transfers, method qualifications, and method validations including protocols and final reportsWrite, revise, and review Standard Operating Procedures (SOPs) and other GMP documentation to support compliant QC operations.Identify, document, and investigate out-of-specification (OOS) results, deviations, and excursions in a timely and compliant mannerPrepare and handle experimental and test materials in accordance with SOPs, Good Manufacturing Practices (GMP), biosafety requirements, aseptic techniques, and applicable safety guidelinesMaintain complete, accurate, and contemporaneous records in compliance with Data Integrity (ALCOA+) principlesPerform analytical and functional assays to support multiple clinical research protocols and GMP lotsAssist in the design, execution, analysis, and interpretation of experiments, including method development and troubleshooting, as assignedCollaborate with cross-functional teams (e.g., Quality Assurance, Manufacturing, Process Development) to ensure timely sample testing, issue resolution, and results reportingParticipate in continuous improvement initiatives to enhance QC efficiency, robustness, and regulatory complianceQualificationsBachelor's degree in a Life Sciences discipline is required; Master's degree or Doctorate preferredMinimum of five (5) years Quality Control experience working within a cGMP-controlled environment; Analytical Development experience preferredDemonstrated knowledge and practical application of GMP principles within cell therapy manufacturingStrong technical expertise in flow cytometry (experience with CytExpert preferred); with additional competencies in ELISA/MSD, mammalian cell culture, and biochemical assays.Excellent interpersonal, written, and verbal communication skills, with the ability to thrive in a fast-paced, collaborative environmentProven ability in problem-solving, root cause analysis, and making sound decisions when working with limited or complex dataDemonstrates sound judgment in selecting appropriate methods and approaches to achieve results efficiently and compliantlyAble to work flexible working hours, including occasional evenings and weekends as needed (included in base salary)Willingness to travel as required to support external manufacturing and testing activitiesRequired SkillsExtensive experience with bioanalytical assaysStrong working knowledge of GMP requirements for late-stage and commercial cell therapy products in the United StatesPreferred SkillsExperience with CytExpert preferredThis role is based in a clinical manufacturing laboratory and involves routine use of manufacturing equipment in accordance with GMP protocols. The position may include exposure to cryogenic.Equal Opportunity StatementKaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.