Continued Suitability for Use, Scientist III (1061-679)
This is a hands-on non-supervisory position in the Reference Standard Technical Operations (RSTO) Department within the Global Laboratory Operations (GLO) division. The incumbent in this role will support the USP Continued Suitability for Use Program (CSU), which will include database management, preparing and reviewing CSU testing protocols, providing technical assistance to testing labs, reviewing analytical data and preparing summary reports to assist in confirming the continued suitability of USP Reference Standards in support of USP’s Mission and core business.
Roles and Responsibilities:
- Supports the day to day operation of the CSU program covering the USP RS catalog inventory.
- Reviews testing history, drafts test protocols for lab submission based off designated testing requirements and schedules.
- Reviews lab reports, summarizes and compares results to previous data and compiles historical results into summary reports.
- Assists labs to ensure testing is completed accurately and in timely manner.
- Maintains and updates various databases documenting laboratory data and program determinations on suitability and CSU interval updates.
- Works collaboratively with respective USP departments including Quality Assurance to investigate unexpected CSU testing results indicating a potential lack of RS suitability for use.
Bachelor's degree in Chemistry or a related scientific field and 7 years of relevant experience or Master’s degree in Chemistry or a related scientific field and 5 years of relevant experience or Ph.D. in science.
Excellent technical writing and oral communication skills required. Must be able to communicate effectively with both internal and external customers. A working knowledge of general analytical methodologies is required. A thorough understanding of basic organic chemistry is a plus. Knowledge of USP products and services highly desirable. Operates collaboratively at all levels of the organization in a highly technical environment. Must be able to work in a fast-paced environment and respond to shifting priorities. Ability to effectively multi-task/manage multiple parallel projects. Working knowledge of relevant computer applications, especially MS Word and MS Excel are required. Oracle ERP experience a plus.
USP offers an impressive benefits package, including:
- Generous paid time off – 13 paid holidays, 10 sick days and 15 vacation days per year to start
- An annual 401(k) contribution, beginning after 1 year of service, of 10% of pay (base and bonus) every pay period that vests immediately
- Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles ($250/individual or $500/family)
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
Being a part of USP means belonging to a diverse culture made up of more than 1,000 talented professionals working together at five international locations. We share our expertise in science, IT, human resources, quality assurance, communications, administrative management, and more...all to support an overall mission dedicated to making a difference by providing standards and programs that help improve the quality of medicines, dietary supplements, and foods worldwide.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.Job Location Rockville, Maryland, United States Position Type Full-Time/Regular