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Job #03624

About our client Our client is an international pharmaceutical company focused of the development and production of treatments for a variety of indications. They have a number of marketed products and put a strong emphasis on the quality of each one. This is an excellent opportunity for the right person. Position Location Quality Engineer Utah Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide quality assurance support for Manufacturing, Supply Chain and Quality Control Laboratories 2) Use data trends to work with operating departments to facilitate process improvements and lean concepts 3) Provide review and approval for protocols/discrepancies, methods, specifications, process/facility, deviations, lab inquiries, procedures, etc. 4) Participate in cross-functional improvement and process monitoring teams to mitigate unfavorable trends 5) Provide QA review and approval of new and existing methods/procedures, validation/transfer protocols, investigation documentation and process/facility change control documents 6) Lead and/or participate in scheduled and unscheduled audits of operational areas 7) Provide backup to record review for final review/release of production batch records 8) Contribute to a motivating work environment, where superior performance is defined, supported, rewarded and recognized 9) Provide first response and ongoing QA presence for quality and compliance issues on the manufacturing floor and the laboratories 10) Participate in internal audits Requirements 1) Bachelor’s degree in Science or Engineering 2) ASQ CQE/CQA certification 3) Minimum 5 years of QA experience in the Pharmaceutical or a related industry or equivalent 4) Experience in creating performance metrics, having performed the corresponding analysis and reports 5) Experience in handling deviations, investigations, CAPAs preferred 6) Experience in Trackwise, SAP, LIMS/Labware and Statistical Software 7) Knowledge of and experience in applicable processes, quality systems, validation, investigation review 8) Demonstrated working knowledge of cGMP and applicable regulatory requirements 9) Working knowledge of TrackWise and Crystal Reports highly preferred 10) Sound background/understanding of applied statistics 11) Excellent computer skills (MS Office suite with working knowledge of computer relational databases) 12) Strong project management and advanced presentation skills 13) Detail-oriented team player with strong interpersonal skills 14) Excellent written and verbal communication skills 15) Proven ability to work in a team environment through conflict resolution and negotiation