Scientist III (1138-679)
This is a hands-on non-supervisory position in the Reference Standards Technical Operations (RSTO) Department within Global Laboratory Operations (GLO). The incumbent is responsible for the quality and technical review of the documents associated with reference material candidates for use in compendial monograph testing.
This position is a component of USP’s core business and the incumbent is expected to support departmental quality initiatives.Roles and Responsibilities
- Performs technical and quality review of test protocols for reference material candidates in accordance with established SOP’s, Operation Manuals, and training documents. The incumbent will be responsible for ensuring the protocols contain sufficient and appropriate identity and purity tests for the candidates.
- Performs technical and quality review of the Reference Standards Candidate Evaluation Packages (RSCEP’s) in accordance with established SOP’s, Operation Manuals, and training documents. The review includes evaluation and interpretation of IR, MS, and NMR spectra, chromatography, moisture analysis, and other tests as needed for the candidate.
- Assists in investigations of quality related issues identified by the labs, found during the data review, or resulting from customer complaints. Identifies and implements solutions to technical problems related to the development of test protocols and the analysis of the data.
- Works professionally and collaboratively with fellow Reference Standard Scientists, Scientific Liaisons, Reference Standards Laboratory staff, QA, and other relevant departments in the review and development of the reference standard candidate.
- Performs other duties as assigned.
Bachelor’s degree in Chemistry or a related field with 7 years of industry experience, an MS degree with 5 years of experience, or a Ph.D.
- Excellent technical writing and verbal communications skills.
- Experience reviewing scientific tests for accuracy, and high regard for quality.
- Proven ability to work in a high-volume, fast-paced environment with changing deadlines and priorities.
- Technical and analytical skills, including the ability to interpret technical information.
- Knowledge of issues related to the evaluation of purity and content of chemical materials.
- The ability to communicate effectively with diplomacy and enthusiasm.
- Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner.
- Working knowledge of relevant computer applications and ability to quickly learn new applications as needed.
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