Scientist III/IV, Instrumentation Support Analyst (932-679)
The Promoting the Quality of Medicines (PQM) program, under the Global Public Health (GPH) division provides technical assistance (TA) to developing countries in the area of medicines quality assurance, regulatory system strengthening and current Good Manufacturing Practices (cGMP). Critical to the success of our TA intervention is continuous functioning and proper maintenance of analytical instruments, including but not limited to High Performance Liquid Chromatography (HPLC), Spectrophotometers (UV/VIS, IR, FTIR etc.), and Karl Fischer, among others. PQM is looking for a highly motivated individual to oversee the implementation of the newly developed Analytical Instruments Support Program (AISP), which is an initiative aimed at supporting laboratories to develop and implement analytical instrument maintenance strategy. This is a hands-on, non-supervisory position with primarily responsible for providing TA in such areas as laboratory instrument servicing, calibration, and qualification. The incumbent provides training to laboratories in developing countries on proper use, maintenance and care of laboratory instrument in support of ISO/IEC 17025 accreditation and WHO- prequalification.
Roles and Responsibilities:
- Support developing country laboratories to develop and implement instrument maintenance strategies to ensure continuous operation of analytical work
- Works with vendors to ensure that laboratory instrument is properly installed, qualified, calibrated, and is operated in accordance with ISO 17025 guidelines.
- Works with field laboratory staff to execute validation protocols and studies. Reviews and/or approves validation protocols and completed reports as necessary
- Investigates, evaluates, and recommends the purchase of laboratory instrument and software.
- Performs laboratory instrument and software installation and provides instrument qualification support in field laboratories.
- Performs instrument repairs on a variety of different instrumentation, as required.
- Provides instrument operation and maintenance training to field laboratory staff.
- Supports field laboratory instrument compliance for ISO 17025 and WHO Prequalification audits
- Provides training to field laboratory staff in QC testing of medicines, QA/QC, GLP, and SOPs
- Pursues, recommends, and implements new approaches or processes to improve laboratory operations
- Leads project teams
- Review project plans, data, and reports for various laboratory scientists
- Demonstrates solid scientific approach to analysis in the laboratory
- Reviews literature for analytical test methods, as well as interprets and evaluates data;
Bachelor's or Master’s degree in physical science or engineering (equivalent years of experience may be considered)
Minimum of five (5) years for M.S. (or 7 years for B.S.) of relevant metrology and quality assurance experience in a pharmaceutical or other regulated industry.
- Knowledge, Skills and Abilities:
- Knowledge of analytical chemistry and QA/QC processes in the pharmaceutical industry preferred.
- General understanding of ISO 17025, 9001, and WHO Prequalification; and general understanding of cGMPs.
- Demonstrated excellent technical writing and oral communications skills.
- Previous experience with Agilent, Shimadzu, and Waters liquid chromatography systems is preferred.
- Solid skills in MS Word, Excel, and PowerPoint.
- Some computer programming skills and a knowledge of visual basic is a plus.
- Language skills a plus (English, Spanish, or French
- Ability to travel at least 35% of the time to international locations
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