Quality System Associate

**Description**

At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds—regardless of background—to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

**Brief Job Overview**

This is a hands-on, non-supervisory professional position that supports the important work of USP’s Quality Assurance Activities. The Quality systems Associate is the expert in management of the tool of Quality Management System (MasterControl) including all quality documentation and training with respect to business objectives, provides guidance regarding Document workflow, proof-reading, and accuracy of documents. All Document Control functions must be compliant with applicable ISO Requirements and industry best practices. This position is responsible for managing user accounts, organizing, maintaining, and updating all controlled documents and ensuring training is assigned and executed in a timely manner. The Quality System Associate trains all levels of users in QMS tool and collaborates with all departments to maintain a compliant document management/training system and meet business needs. This position works independently, with mínimal supervision, to accomplish daily tasks by efficiently and effectively utilizing the Company’s QMS tool. The Quality System Associate will drive continuous improvement within the system and create/report metrics regarding document status, priority, change management, training completion, and issue management. This position is also leading/supporting workflow development by utilizing the QMS tool to enhance the quality system and improve the process efficiency.

This position is also responsible for performing documentation review/release of lab projects, batch records, and equipment qualification. This position will also support the Global Supplier Quality Management Program.

**How will YOU create impact here at USP?**

As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.

Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.

The Quality System Associate has the following responsibilities:
**Document Control activities (at least 50%)**:
- The Quality System Associate is the QMS tool SME, responsible for managing all aspects of the document management processes, as well as training.- Review, edit and format documents, approves document change requests, release approved documents and manages document workflows, including new document, document revision and document obsoletion. Review of Standard Operating Procedures (SOPs) and other documentation, including work instructions, to ensure accuracy and compliance.- Manages QMS tool users including activating and deactivating users, assigning appropriate roles per business needs, maintaining/assigning job codes, creation of new hire training infocard and assigning new hire mandatory trainings.- Creation of training courses, sessions, and support trainers on updating of class roll.- Serves as the MasterControl System Administrator/SME and provides training/guidance to all levels of system end-users regarding processes of document management and training, and QMS tool(s). Resolve issues during trouble-shooting requests.- Designs/develops/maintains training courses, instructional materials, and training records for the various levels of system users.- Improves and streamlines processes of document management, training, issue management and user management.- Develop, improve workflows in the QMS tool to enhance the efficiency of processes.- Develops/maintains/reports metrics periodically regarding document management, training, issue management, user manage