Purpose: Quality Control (QC) Analyst is responsible for sample receipt, testing intermediate production samples, final product samples, and environmental samples to demonstrate that all products meet the standard requirements for CGMP operations. Additional functions include raw material testing, stability testing, assay transfers, and qualification of instrumentation. The Quality Control Operations group supports Laboratory Investigations, Deviation Investigations, CAPA support, Training, and Change Controls. Quality Control Validation Support consists of the Method Validation Group and the Equipment Qualification Group. Quality Control is also responsible for assisting in site wide studies and projects.ResponsibilitiesExecuting analytical testing in a timely manner, ensuring adherence to the committed scheduled plansPerforming tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasksRecording all expected raw data, calculations, information, related to tasks, to comply with cGMP and data integrity requirementsEnsuring that he/she is trained and qualified to the assigned analytical testing that requires qualificationPerforming the QC data review of executed tests by other analysts in a timely manner, ensuring adherence to the committed scheduled plansInforming his/her manager of any quality or HSE event (deviations, OOx,…) in a timely manner to ensure investigation and impact assessment are performed appropriatelyParticipating actively in any investigation in which he/she is involved, to ensure investigations and impact assessment are performed appropriatelyExecuting assigned CAPAs related to remediation plans, continuous improvementsEnsuring that his/her lab/facilities, lab instruments are kept in a quality and safe status so that they can be used appropriatelyQualificationsBachelor's degree in pharmacy, chemistry, biochemistry, microbiology, life sciences, or a related field3+ years of experience in a quality control laboratory environmentExperience in analytical testing of raw materials, intermediate and final products, and environmental samplesExperience with stability testing, assay transfers, and instrument qualificationProficient in performing tests according to cGMP and HSE standardsSkilled in recording and reviewing raw data accurately, ensuring data integrityExperience in laboratory investigations, deviation investigations, CAPA execution, change controls, and training supportFamiliarity with method validation, equipment qualification, and site-wide quality improvement projectsStrong attention to detail and adherence to schedulesAnalytical and problem-solving skills with the ability to work collaboratively in a teamAbility to maintain laboratory safety, quality, and compliance standards
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