Senior QA Engineer in Dressler Consulting

Please only apply if you have experience working in Healthcare/Pharmaceutical industry and have sound knowledge of HIPAA, GMP and GDPR compliances Company Description: The Client is charting a new path in health research with its clinical trial automation platform, contributing to the ongoing digitalization of health innovation.About the job:The Client has an immediate opportunity for Quality Assurance and Compliance Manager to work in a FDA-regulated environment. This position supports validation and testing of a patient and provider facing web applications used in clinical trials.Qualifications:● BS degree and/or equivalent experience in related discipline● 5+ years experience in quality assurance● 2+ years in compliance● Pharmaceutical industry experience● Experience with aspects of pharmaceutical GMP regulations (e.g. quality systems, root cause analysis and Total Quality Management).● Knowledge of GMP including international regulations.● Knowledge of applicable parts of 21 CFR regulations.● Ability to handle multiple and changing priorities and tight deadlines while remaining detail-oriented.● Good verbal and written communication skillsResponsibilities:● Write and execute test cases for the Client platform● Manage work to develop automated testing for those test cases. (Note, this individual will not be responsible for authoring/coding the actual automation)● Develop, improve, and monitor Quality Systems for the entire organization.● Continuously improve areas impacted by deviations and approve appropriate CAPAs.● Support and facilitate Good Clinical Practice (GCP/GXP) audits.● Write and revise standard operating procedures (SOPs).● Provides direction and oversight during active processes and apply understanding of FDA regulations (21 CFR 11, 21 CFR 820), FDA Quality Systems and Continuous improvement.● Able to independently organize and perform own work tasks and assist coordinating activities to support production schedule thru other co-workers.● Correct ineffective procedures and policies● Able to work effectively with team members and vendors, contractors, or suppliers with the aim of ensuring their products or services meet the organization’s quality standards.Working conditions:Note: Client requires work-time overlap within their time zone (specified below).Mon – Fri 9-5 (EST) overlap at least four hours with team. Show more Show less Посадовий рівень Старший середній рівень Тип зайнятості Повний робочий день Посадові обов’язки Інженерія і Інформаційні технології Галузі ІТ-послуги та ІТ Консалтинг