Quality Engineering Temp

DI Program SpecialistWe are seeking a highly motivated individual to join as a DI Program Specialist. You will work with the Quality Engineering team in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting to the QE Sr Manager – DI Program Lead.Job Responsibilities:Assist DI Lead in the implementation of the Global Data Integrity ProgramCollaborate in the review and creation of DI Standards and procedures as required.Prepare documents for internal and external information/auditsCollaborate, perform or review data integrity assessments and mitigation workSupports project deadlines and ensures performance standards are metEnsures compliance with all Kite Pharma Data Integrity policies and procedures.Provides DI support during compliance inspections conducted by external sourcesSuggests resolution of DI compliance concerns to Program LeadCollaborate in the maintenance of the Data Integrity Program Charter updates and provide frequent status reportsParticipates in meetings, conference calls, and other interactions with stakeholders.Prepare and coordinate data/reports for the Integrity Management Program TeamConduct or assist in DI live or web-based training courses as required – virtually and on-siteAssist with the development of training aids, including training handbooks, multimedia visual aids, computer tutorials, and other reference materials as neededCollaboration with stakeholders, business process owners, and system owners, in getting to understand their data needs and requirementsProvide customer guidance, recommendations, and solutions throughout the entire DI implementation process.Share industry knowledge, proven process flows, and best practices to assist them in meeting their DI needs.Keep current on industry trends in the Data Integrity guidelinesExperience Requirements:6+ years of relevant experience in a GMP environment-related field and a bachelor’s degree.Prior experience in the pharmaceutical industry is beneficial.Prior experience, quality, and/or mfg experience in the regulated industry for medicinal products.6+ years’ experience in an FDA-regulated environment with a strong understanding of cGxP standards and Risk-based validation.Knowledge of Data Integrity guidances and industry standards (i.e., FDA, MHRA, PICs).Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biotechnology, pharmaceuticals, and medical devices.Experience in developing or reviewing Validation Plans, Requirements, Design Specifications, Test Protocols, Deviation management, Traceability matrices, and Validation Summary Reports.Cell culture experience is a plus.Knowledge of pharmaceutical manufacturing of biotechnology products, cell therapy products, and process development is a plus.Must be able to function and contribute as part of a team, have excellent communication skills, and contribute to team-based decisions.Ability to think critically and utilize troubleshooting and problem-solving skills.Ability to function efficiently and independently in a fast-paced, changing environment.Self-motivated and willing to accept temporary responsibilities outside of the initial job description.Well-developed computer skills and fluent with Client office applications.Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities.Strong verbal and written communication skills.