Senior Validation Analyst
RevereIT, LLC has job openings for Sr. Validation Analyst (Regulatory Affairs). Analyze requirements for various equipment or systems in compliance with Federal Rules and Regulations related to various pharmaceutical and/or medical device manufacturing facilities. Coordinate, prepare, or review documents related to regulatory submissions for various domestic and/or international projects. Write or update standard operating procedures, work instructions, or policies. Prepare and review protocols and identify gaps performing Root Cause Analysis. Track defects using Defect Management Tool and create deviation summary report. Provide technical review of data or reports that will be incorporated into FDA submissions to assure scientific rigor, accuracy, and clarity of presentation. Maintain or coordinate current knowledge base of existing and emerging regulations, regulatory standards, or guidance documents. Prepare and assist in development and review of Validation Protocols. Compile and maintain regulatory documentation databases or systems. Participate in internal or external audits. Travel/relocate to various unanticipated locations throughout the U.S. for long and short-term assignments at client sites. Master's degree or foreign equivalent in Regulatory Affairs, Pharmaceutical Sciences, Pharmacy, Chemistry, Biology, Molecular Biology and Microbiology or in a related life sciences discipline. Job location: our office at 45640 Willow Pond Plaza # 200, Sterling, VA 20164. Travel and/or relocation to client site any- where in U.S.A. is a must. Likely candidates will be tested on their general ability to perform the above tasks. Mail resumes to HR Manager, RevereIT LLC, 45640 Willow Pond Plaza # 200, Sterling, VA 20164. No PHONE CALLS PLEASE. RevereIT LLC is an EQUAL OPPORTUNITY EMPLOYER.