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Form of workWho is USP?
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's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Brief Job Overview
This is a non-supervisory position within the Verification department of USP’s Global Laboratory and Technical Operations (GLTO) division. The incumbent will be 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.
How will YOU create impact here at USP?
You will serve as the primary and/or secondary contact for participants in the verification program(s) and will manage verification projects, working closely with participating companies and with fellow staff throughout the verification process to ensure timely completion of work. You will be responsible for the preparation and/or evaluation of cGMP site audits/reports, QCM documentation/reports, and test data/results regarding facilities and products undergoing verification. In addition, you will help develop and implement new tools, procedures, and techniques for the verification department to meet USP’s objectives and the needs of the verification program’s 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.
Specific responsibilities include:
• 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 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.
Who USP is Looking For?
The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
• Scientist IV: M.Sc. degree in analytical chemistry, biochemistry, or other related fields with minimum of 8 - 10 years of relevant experience (or equivalent combination of education and experience, e.g., B.S. degree and 10 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.
• Sr. Scientist I/II: M.Sc. degree in analytical chemistry, biochemistry, or other related fields with minimum of 10 (Sr. Sci I) or 12+ years (Sr. Sci II) of relevant experience (or equivalent combination of education and experience, e.g., B.S. degree and 12 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.
Additional Desired Preferences
• 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.
• Third-party quality certification/verification experience in the pharmaceutical or dietary ingredient/supplement industry is a plus, but not required.
• Language skill in Chinese (Mandarin) or Spanish is a plus, but not required.
Supervisory Responsibilities
None.
Benefits
USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing is protected.
COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired):
As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
Note: 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.
