Summary of the Position
This is a hands-on non-supervisory position that supports the important work of USP's verification programs. Responsibilities include conducting and implementing activities related to current Good Manufacturing Practice (cGMP) site audits; quality control and manufacturing (QCM) product documentation reviews; and product sample testing for conformance to applicable compendial standards for the USP verification program (VER) department. 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
Technical Review, Testing and Auditing Services:
- Conducts thorough review and evaluation of QCM [i.e., quality control and manufacturing] documents and other data received from pharmaceutical and dietary supplement manufacturers to ensure compliance with USP VER requirements; and prepares reports on observations made during the review and enters into correspondence with participants of the programs with the intent to ensure that acceptable corrective actions are taken where needed.
- Assists the senior director of the VER and senior staff to ensure compliance with VER procedures and requirements in the preparation of summary reports and approval letters for the final disposition of products undergoing verification, for submission to the senior director, verification programs.
- Works collaboratively with all parties to create a work schedule with VER 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 in VER to ensure that surveillance audits/internal audits and surveillance documentation review and product testing are conducted according to program requirements.
- Helps track VER statistics (e.g. new and potential participants, verified products, renewal dates) and ensures that information on the USP VER website is current.
- Performs other duties as assigned.
- Develops and revises the standard operating procedures (SOPs) and participant manuals for VER, for continual improvement of the program requirements and operation, in collaboration with verification department staff and with other USP department (e.g., QA and Legal) staff.
- Effectively assists chemists who conduct major analytical work by ensuring testing is carried out in accordance with the project plan.
- Participates in internal audits of VER and works with VER staff to respond and initiate corrective action for audit findings.
- Works collaboratively with VER staff based at USP Headquarters and other USP sites (India and China).
- Coordinates with VER participants for surveillance testing and required documents as per VER requirements.
- Completes requisition orders and expense reports for travel and materials related to VER activities.
- Performs other duties as assigned by Head, IS & VER, or designee.
- Participates in USP Pharmacopeial Education (PE) courses, when needed.
- Conducts site audits of VER participants, when required.
- Prepares audit reports summarizing the results of the site audits and makes recommendations regarding site compliance with cGMP requirements.
- Follows-up with manufacturers to verify corrective action stated in the audit response report and prepare status report for the VER department.
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.
- The incumbent should have extensive knowledge of FDA regulations pertaining to cGMP requirements.
- Should be proficient with regulation and guideline interpretation, audit procedures, proper documentation, and QA and departmental policies and procedures.
- 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.
- Should have knowledge of and experience with analytical methodologies.
- Should have good organizational, planning, and excellent verbal and written communication skill; the ability to speak, read and/or understand a foreign language is desirable.
- Should be detail oriented; able to deal with multiple changing priorities; and able to work with minimal supervision.
- Effective and efficient project management experience is desirable.
USP offers an impressive benefits package, 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.
Job Location Rockville, Maryland, United States Position Type Full-Time/Regular