Monday to Thursday, 5:00 AM - 3:30 PM; with flexibility to work evenings, weekends, or holidays as required by operational needs Job Summary Radnostix, Inc. is seeking a detail-oriented Quality Control Analyst to support testing of Sodium Iodide (I-131) products in a regulated radiopharmaceutical environment. The role will predominantly perform HPLC and gamma spectroscopy testing, together with microbiological sampling and additional physical and chemical test methods. The successful candidate will also support laboratory investigations, analytical method development and validation, and broader Quality activities. As part of a small but mighty company, the analyst will be expected to work collaboratively across functions and contribute to batch review, continuous improvement initiatives, and project work as business needs require. Key Responsibilities Laboratory Oversight & Operations Perform laboratory activities in accordance with approved procedures, data integrity requirements, and applicable current Good Manufacturing Practice (cGMP) requirements. Maintain complete, accurate, and contemporaneous laboratory records and generate clear testing reports. Maintain assigned instruments and laboratory equipment in a calibrated, qualified, and inspection-ready state. Support laboratory investigations involving deviations, out-of-specification (OOS) results, and system suitability failures, including documentation, data review, root-cause evaluation, and implementation of assigned corrective actions. Testing & Analysis Perform routine and non-routine HPLC testing of Sodium Iodide (I-131) samples using applicable detection systems and approved analytical procedures. Perform gamma spectroscopy testing of Sodium Iodide (I-131) samples and accurately evaluate, document, and report results. Perform microbiological sampling in controlled manufacturing and laboratory areas, coordinate sample handling and testing as applicable, and review associated results. Perform additional testing, including appearance, pH, brittleness, loss on drying, moisture uptake, and other methods as required. Support analytical method development, transfer, verification, and validation activities, including protocol execution, data analysis, and report preparation. Review analytical data for completeness, accuracy, compliance with specifications, and adherence to approved procedures. Quality Assurance Support Support batch record and laboratory data review to help ensure product disposition activities are completed accurately and on schedule. Participate in deviation and OOS investigations, corrective and preventive actions (CAPA), change controls, and other Quality System activities as assigned. Contribute to continuous improvement initiatives that strengthen laboratory efficiency, compliance, data quality, and operational reliability. Support cross-functional projects, validation activities, stability studies, inspections, audits, and other Quality priorities as business needs require. Work effectively in a small-company environment where flexibility, ownership, and willingness to support responsibilities outside the laboratory are essential. Required Qualifications and Experience Bachelor's degree in Chemistry, Analytical Chemistry, Biochemistry, Microbiology, or a related scientific field; an equivalent combination of education and relevant experience may be considered. At least one year of analytical laboratory experience; hands-on HPLC experience is required. Experience with gamma spectroscopy, radiopharmaceutical testing, or radioactive materials is preferred but not required. Working knowledge of laboratory investigations, system suitability, OOS processes, method validation, and cGMP documentation practices is preferred. Familiarity with applicable requirements and standards, including
FDA 21 CFR
211 and United States Pharmacopeia. Strong attention to detail, sound technical judgment, and effective written and verbal communication skills. Ability to organize competing priorities, work independently, collaborate across functions, and adapt to changing business needs. Ability to work safely with radioactive materials; radiation-worker training will be provided if needed. If you are a motivated, detail-oriented analyst who enjoys hands-on laboratory work, technical problem-solving, and contributing across Quality functions in a collaborative small-company environment, we encourage you to apply. Applicants must be legally authorized to work in the United States at the time of application and throughout employment. Employer sponsorship for work visas is not available for this position.
Pay:
$25.00 - $32.00 per hour Expected hours: 40.0 per week
