Documentation Specialist

At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds—regardless of background—to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

Brief Job Overview

 This is a non-supervisory technical position responsible for conducting onsite Good Manufacturing Practice (GMP) facility audits and reviewing ingredient and dietary supplement quality control manufacturing (QCM)/Chemistry and Manufacturing Controls (CMC)  documentation for products submitted into the USP Verification Programs (VER).

How will YOU create impact here at USP?

 As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards.

Additionally, USP's People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments.

The Documentation Specialist-Scientist III/IV has the following responsibilities:

• Review audit and QCM/CMC corrective action responses from VER participants and assess compliance with GMP and VER program requirements and provide assessment reports..
• Review QCM/CMC documentation for ingredients and dietary supplements, API (Active Pharmaceutical Ingredients), excipient, dietary ingredients submitted by VER participants.
• Prepare timely QCM/CMC product documentation review reports, listing observations/nonconformities.
• Prepare, review, and approve laboratory test protocols.
• Conduct GMP site audits, review audit reports, and assess compliance with GMP and VER program requirements.
• Audit dietary supplements, API, excipient, dietary ingredient manufacturing sites, and contract testing laboratories.
• Coordinate with lab staff on testing requirements and project status.
• Provide support and review laboratory investigations and deviations to ensure documentation accuracy.
• Review and update VER SOPs, participant manuals, and other documents.
• Assist VER lab scientists in conducting verification analytical work, ensuring compliance with test protocols.
• Work with VER staff at USP – USA and other USP sites.

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:

Scientist-IV:

• Master's degree in science area (Chemistry, Pharmacy) and a combination of skills and experience in the pharmaceutical or related industry, preferably working in Analytical Lab, Analytical reviewer role/Quality Assurance in API or formulations
• A minimum of 8-10 years of experience in Quality, including developing and implementing a Quality Management System.

Scientist-III:

• Master's degree in science area (Chemistry, Pharmacy) and a combination of skills and experience in the pharmaceutical or related industry, preferably working in Analytical Lab, Analytical reviewer role/Quality Assurance in API or formulations
• A minimum of 6-8 years of experience in Quality, including developing and implementing a Quality Management System.

Must have:

• Regulatory & GMP Expertise: Strong understanding of cGMPs (21 CFR Part 111, 117, 210 & 211), ICH, FDA regulations, WHO and industry standards like ISO, USP etc.
• QMS & Documentation Skills: Proficiency in SOPs, CAPA, deviation handling, change control, batch record review, and data integrity principles.
• Strong written and verbal communication skills, including well-developed interpersonal skills used to influence the behavior of others and the ability to provide candid feedback at all levels.
• Ability to prioritize, manage time well, multitask and troubleshoot.
• Working knowledge of MS Word, PowerPoint, Excel etc.,

Additional Desired Preferences

Desired preferences are to showcase any additional preferred levels of expertise to perform the role. Reminder: any items listed in this section are not requirements nor disqualifies for candidate consideration.

• A certificate from the American Society for Quality (ASQ) as a Certified Quality Auditor (CQA) is optional.
• Trained in internal/external audits, supplier qualification, inspection readiness, and risk-based auditing approaches.
• Familiarity with analytical methods, product specifications, and testing standards for dietary supplements, its ingredients, excipients and Active pharmaceutical ingredients.
• Sharp eye for detail, critical thinking, problem-solving mindset, and unwavering commitment to quality and integrity.

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.

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.