Verification Scientist IV
Location: Rockville
Posted on: June 23, 2025
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Job Description:
Description Who is USP? The U.S. Pharmacopeial Convention (USP)
is an independent scientific organization that collaborates with
the world's top authorities 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 1,300 hard-working professionals across twenty global
locations to deliver the mission to strengthen the supply of safe,
quality medicines and supplements worldwide. At USP, we value
inclusivity for all. We recognize the importance of building an
organizational culture with meaningful opportunities for mentorship
and professional growth. From the standards we create, the
partnerships we build, and the conversations we foster, we affirm
the value of Diversity, Equity, Inclusion, and Belonging in
building a world where everyone can be confident of quality in
health and healthcare. 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 workan environment where every employee feels fully empowered
and valued irrespective of, but not limited to, 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. Brief
Job Overview This is a non-supervisory position within the
Verification department of USPs 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? In this role at USP, you contribute to
USP's public health mission of increasing equitable access to
high-quality, safe medicine and improving global health through
public standards and related programs. In addition, as part of our
commitment to our employees, Global, People, and Culture, in
partnership with the Equity Office, regularly invests in the
professional development of all people managers. This includes
training in inclusive management styles and other competencies
necessary to ensure engaged and productive work environments. 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 USPs objectives and the needs of
the verification programs participating companies in order to
support continued growth of the verification services as a center
of excellence within USPs fast-paced, rapidly changing organization
The Verification Scientist IV has the following 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 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 is USP 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: Education and Experience:
M.Sc. degree in food science, analytical chemistry, biochemistry,
or related fields. Minimum of five (5) years of relevant
experience, or equivalent combination of education and experience
(e.g., B.S. degree with a minimum of seven (7) years of
experience). Experience working in current Good Manufacturing
Practice (cGMP) facilities involved in the manufacturing and/or
QA/QC of foods, pharmaceuticals, and/or dietary
supplements/ingredients. Industry Experience: Proven experience in
establishing quality systems compliance within the above fields.
Willingness to travel approximately 10% domestically and
internationally Additional Desired Preferences Extensive knowledge
of FDA regulations pertaining to cGMP requirements. Knowledge of
and experiences with GMP audits using 21 CFR parts 111 and 117 are
desired. 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
Supervisory Responsibilities None, this is an individual
contributor role. Benefits USP provides the benefits to protect
yourself and your family today and tomorrow. From company-paid time
off and comprehensive healthcare options to retirement savings, you
can have peace of mind that your personal and financial well-being
is protected. Compensation Base Salary Range: USD $85,500.00
$111,250.00 annually. Target Annual Bonus: % Varies based on level
of role. Individual compensation packages are based on various
factors unique to each candidates skill set, experience,
qualifications, equity, and other job-related reasons. 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. Equal
Opportunity Employer/Protected Veterans/Individuals with
Disabilities This employer is required to notify all applicants of
their rights pursuant to federal employment laws. For further
information, please review the Know Your Rights
(https://www.eeoc.gov/poster) notice from the Department of Labor.
Job Category Chemistry & Scientific Standards Job Type
Full-Time
Keywords: , Arlington , Verification Scientist IV, Science, Research & Development , Rockville, Virginia