NorthStar Medical Radioisotopes, LLC – $90,667.00/Year

Applicants must have demonstrated experience withbr br Pharmaceutical industry in a Qualification or Validation role;br Working with current validation principles, standard concepts, practices and procedures, and requirements in a cGMP regulated environment;br Statistical Analysis;br 21 CFR Part 11, 21 CFR Part 210 and 21 CFR Part 211;br Computer System Validation, EquipmentInstrumentUtility Qualification and Process Validation;br RiskBased Approach to commissioning and qualification such as ISPE and GAMP 5;br Waterfall model and VModel;br Executing protocols using automated test management tools such as HP ALMApplication Lifecycle Management;br Performing Risk Assessments, Data Integrity Assessments, and Gap Assessments.