Job Description

VALIDATION ANALYSTS, Job Code 1104:

ITVorks Inc., seeks Validation Analysts for its Princeton, NJ office to Review documents including clinical study reports, labeling drafts and validation and stability protocols and reports. Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare Test Plan and Final Validation Report. Perform GAP analysis on GXP system that directly affects product quality and Data Integrity and ensure all the requirements have been tested and also comply with applicable FDA Regulations. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical production. Prepare and submit of Chemistry, Manufacturing, and Controls (CMC) sections for regulatory drugs and submissions, information amendments, supplements, and annual reports. Travel to various unanticipated locations in the United States to interact with clients for short or long term assignments. Master’s Degree or foreign equivalent in Pharmacy/Regulatory Affairs/Chemistry or related + 1 yr of experience as Clinical Analyst, Regulatory Affairs Associate, QA Engineer or related, developing/creating Test Plan, and using software validation life cycle and EDC applications (Medrio, RAVE and Inform) is required. Work Location: Princeton, NJ. Travel required to interact with clients & train end users.

Please send resume & cover letter indicating position and Job Code to hr@itvorks.com. Human Resources, ITVorks Inc., 101 College Rd East, Suite #302, Princeton, NJ 08540.