Summary of the Position
This is a hands-on non-supervisory position responsible for the oversight and successful implementation and completion of all activities pertaining to a portfolio of Reference Standards (RS). The incumbent is responsible for preparing collaborative testing protocols for new, replacement, and continuation RS lots, providing technical assistance to collaborating labs, reviewing analytical data and preparing summary reports, preparing packaging and Quality Control testing instructions, and providing technical assistance to the Continued Suitability for Use program.
Roles and Responsibilities
Knowledge, Skills and Abilities
- Independently maintain a complex portfolio of RS and ensure their availability through successful scheduling operations, maintaining necessary documents, providing complete and accurate information, and addressing quality issues.
- Draft test protocols, coordinate testing with labs, and review/interpret data from multi-laboratory studies.
- Compile study summary reports for each RS lot.
- Collaborate with Scientific Liaisons to produce integrated, high quality Documentary/Reference Standards packages.
- Provide correct guidance to Expert Committees on the interpretation of test data. Propose and design studies to obtain necessary data to resolve concerns.
- Demonstrate technical understanding to internal and external audiences regarding USP’s RS programs.
- Address general customer technical inquiries and thoroughly investigate customer complaints with minimal guidance.
- Present technical issues/presentations to inter-departmental USP staff.
- Facilitate additional cross-functional activities with other USP staff.
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.
Education and Experience
Bachelor’s degree in Chemistry or a related field with 9 years, an MS degree with 7 years, or a Ph.D with 5 years of industry experience.
US Pharmacopeial - 20 months ago