Scientist IV/III , Verification Programs - Documentation Specialist

At USP, we highly value inclusive scientific collaboration and understand the importance of diverse expertise in enhancing our ability to develop trusted public health standards. We strive to create an organizational culture that promotes equitable access to mentorship, professional development, and leadership opportunities. Our belief is that by ensuring broad participation in scientific leadership, we can achieve stronger and more impactful outcomes for global health. As an equal employment opportunity employer, USP is committed to fair and merit-based selection processes that welcome the best scientific minds regardless of background. We provide reasonable accommodations to individuals with disabilities and uphold policies that foster an inclusive and collaborative work environment. This non-supervisory technical position at USP entails conducting onsite Good Manufacturing Practice (GMP) facility audits and reviewing ingredient and dietary supplement quality control manufacturing (QCM)/Chemistry and Manufacturing Controls (CMC) documentation for products submitted into the USP Verification Programs (VER). Your role at USP will be crucial in advancing scientific rigor and public health standards, contributing to increased global access to high-quality medicines through the establishment of public standards and related programs. We prioritize scientific integrity, regulatory excellence, and evidence-based decision-making to ensure that health systems worldwide can rely on strong, tested, and globally relevant quality standards. As a Documentation Specialist-Scientist III/IV, your responsibilities will include reviewing audit and QCM/CMC corrective action responses from VER participants, assessing compliance with GMP and VER program requirements, reviewing QCM/CMC documentation for various substances, preparing review reports, approving laboratory test protocols, conducting GMP site audits, and coordinating with lab staff on testing requirements and project status, among other duties. USP is seeking individuals for the roles of Scientist-III and Scientist-IV, who possess a master's degree in a science area (such as Chemistry or Pharmacy) along with relevant experience in the pharmaceutical industry, particularly in Quality Management Systems. The ideal candidates will have a strong understanding of regulatory standards, proficiency in QMS & Documentation Skills, effective communication abilities, time management skills, and knowledge of relevant software applications. Desired preferences for these roles include certifications in quality auditing, training in audits and risk-based auditing approaches, familiarity with analytical methods and product specifications, and a commitment to quality and integrity. This is an individual contributor role with no supervisory responsibilities. USP offers comprehensive benefits to protect the well-being of employees and their families, ensuring peace of mind for personal and financial security.,