Quality Assurance Engineer

Job Description: Pay Range: $33hr - $38hr In addition to validation and regulation experience, the resource should have the following experience. 3-7 years of relevant experience; can work independently and guide mentor Junior resources. Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Life Cycle in Computer System Validation Experience in FDA and or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance and industry standards (i.e., GAMP). Experience in writing and executing documentation for all aspects of the validation deliverables etc. Requirements, Compliance Validation Plans, test protocols, Test Summary reports and Compliance Validation Reports. Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures. bility to Review Automated Test script Strong verbal and written communication skills. bility to work as a team player, lead a team or accomplish tasks without supervision. bility to work with remote teams and support several changes projects simultaneously. bility to provide Validation guidance, timely reviews, and escalations to TQ management. Hands-on experience with validation of Data Solutions is preferred.