Company DescriptionQRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields. Log on now to our website http: //www. qrcgroup. com/ to learn more about our services and solutions!Job DescriptionCSV Specialist to provide services of commissioning, equipment qualification (IOQ), computer system validation (CSV), forms and SOPs execution for a Keyence and a vision system upgrade project. QualificationsBS or higher in Chemistry/ Biology/ Microbiology/ Computer Science/ Information Systems/Engineering or related discipline.
Background in pharmaceutical products manufacturing environment and in laboratories areasMore than three (3) years of experience working with PLC’s, Industrial Computers with experience in commissioning and validating laboratory and manufacturing computerized systems in a manufacturing environment, and training in validation methodologies, technologies, and process control computer systems. Knowledge on computerized system with data collection software (database). Strong knowledge of cGMP, GAMP, SDLC, FDA, 21 CFR Part 11 and Data Integrity Regulations. Knowledge in MS Project Management and MS Visio programs.
Experienced in Instrument Performance qualification, and method configurationExcellent skills writing commissioning/ validation, and technical documentation in English and using MS Office applications. Bilingual (both English/Spanish)Additional InformationAll your information will be kept confidential according to EEO guidelines.
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