The U.S. Pharmacopeial Convention (USP) Sr. Scientist III/ Scientist IV, USP Verifications in Rockville, Maryland
This is a non-supervisory position in the Verification group of USP’s Global Laboratory and Technical Operations division. The incumbent is responsible for conducting and implementing activities related to current Good Manufacturing Practice (cGMP) site audits, quality control and manufacturing (QCM) product documentation reviews, and test design for conformance to applicable compendial standards. The incumbent serves as the primary and/or secondary contact for several participating companies and manages verification projects for the companies, working closely with participating companies and with fellow staff throughout the verification process to ensure timely completion of work. The incumbent assists their supervisor in the preparation and/or evaluation of cGMP site audits/reports, QCM documentation/reports, and test data/results, regarding facilities and products undergoing verification. The incumbent anticipates and solves problems and issues within his/her area of responsibility. The incumbent follows and maintains verification department procedures, processes and requirements. In addition, the incumbent helps develop and implement new tools, procedures and techniques for the verification department to meet USP’s objectives and the needs of the verification program participating companies in order to support continued growth of the verification services as a center of excellence within USP’s fast-paced, rapidly changing organization.
Roles and Responsibilities
Conducts thorough review and evaluation of QCM [i.e., quality control and manufacturing] documents and other data received from pharmaceutical, ingredient and dietary supplement manufacturers to ensure compliance with verification requirements. Prepares reports on observations made during the review and corresponds with participants of the programs with the intent to ensure that acceptable corrective actions are taken where needed.
Ensures compliance with verification procedures and requirements in the preparation of summary reports and approval letters for the final disposition of products undergoing verification.
Works collaboratively with all parties to create a work schedule with verification staff, other USP departments, contract auditors, and testing laboratories on matters relating to the verification programs.
Conducts audits and/or coordinates with USP GMP auditors at USP Rockville and at USP international sites to provide necessary assistance to enable the auditor(s) to conduct a thorough audit of program participants’ manufacturing facilities for the manufacture of drug substances, excipients, dietary ingredients, and/or dietary supplements.
Conducts surveillance activities for participants to ensure that surveillance audits/internal audits and surveillance documentation review and product testing are conducted according to program requirements.
Develops and revises standard operating procedures (SOPs) and participant manuals.
Performs other duties as assigned.
Sr. Scientist III : M.Sc. degree in analytical chemistry, biochemistry or other related fields with minimum of five (5) years of relevant experience (or equivalent combination of education and experience, e.g., B.S. degree and 7 years of experience) working in current Good Manufacturing Practice (cGMP) facilities engaged in the manufacturer and/or quality control of pharmaceuticals and/or dietary supplements. The incumbent should have industry experience in the establishment of quality systems compliance within the above field(s). The incumbent must be willing to travel approximately 10% domestically and internationally.
Scientist IV : M.Sc. degree in analytical chemistry, biochemistry or other related fields with minimum of seven (7) years of relevant experience (or equivalent combination of education and experience, e.g., B.S. degree and 9 years of experience) working in current Good Manufacturing Practice (cGMP) facilities engaged in the manufacturer and/or quality control of pharmaceuticals and/or dietary supplements. The incumbent should have industry experience in the establishment of quality systems compliance within the above field(s). The incumbent must be willing to travel approximately 10% domestically and internationally.
Extensive knowledge of FDA regulations pertaining to cGMP requirements.
Proficient with regulation and guideline interpretation, audit procedures, proper documentation, and Quality Assurance.
Certificate from the American Society for Quality (ASQ) as a Certified Quality Auditor (CQA) is desirable.
Working knowledge of the International Conference on Harmonization (ICH) quality guidelines and multidisciplinary guideline on the Common Technical Document (CTD) for APIs is desirable.
Regulatory CMC submission experience and/or industry experience in the establishment of quality systems compliance is desirable.
Knowledge of and experience with analytical methodologies.
Good organizational, planning, and excellent verbal and written communication skills.
Detail oriented; able to deal with multiple changing priorities; and able to work with minimal supervision.
Effective and efficient project management experience is desirable.
Chinese language skill in Mandarin is a plus, but not required.
USP offers an impressive benefits package, including:
Generous paid time off – 15 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.
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements 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