The U.S. Pharmacopeial Convention (USP) Scientist III, Reference Standards Technical Operations in Rockville, Maryland
This is a hands-on professional position in the Reference Standards Technical Operations (RSTO) Department within Global Laboratory and Technical Operations. The incumbent is responsible for the quality and technical review of the documents associated with reference standard candidates for compendial use in testing per USP/NF and PF monographs, as well as for the evaluation of their suitability for continuous using (CSU) and for new using (NU).
This position is a component of USP’s core business where the incumbent supports departmental quality initiatives.
Roles and Responsibilities
Performs technical and quality review of test protocols for reference standard candidates in accordance with established SOPs, Operation Manuals, and training documents. The incumbent will be responsible for ensuring the protocols contain sufficient and appropriate identification, purity, and other tests for the candidates.
Performs technical and quality review of the Reference Standards Candidate Evaluation Packages (RSCEPs) in accordance with established SOPs, 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.
Performs technical and quality review of test protocol, addenda, and other documents associated with Continuous Suitability for Use (CSU) and New Use (NU) programs.
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 that arise.
Bachelor’s degree in Chemistry or a related field with 7 years of industry experience, or a MS degree with 5 years of experience, or a Ph.D.
Prior experience in a scientific based industry.
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.
Excellent technical writing and verbal communication skills.
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.
Ability to work in a high-volume, fast-paced environment with changing deadlines and priorities.
Accuracy, attention to detail, and high regard for quality.
Working knowledge of relevant computer applications and ability to quickly learn new applications as needed.
USP offers an impressive benefits package at http://uspscareers.jobs/benefits/ , including:
Generous paid time off – 14 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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Chemistry & Scientific Standards
Job Type Full-Time