Associate Production Quality Specialist

US Pharmacopeia; Frederick (MD); On-site; Full time

Job summary

A leading organization in the pharmaceutical sector seeks a Production Quality Specialist to support the production of Reference Standards. The role involves documentation management, quality assurance, and collaboration with diverse teams to enhance public health standards. Ideal candidates will possess a Natural Sciences degree and relevant experience, alongside strong organizational skills and attention to detail.

Benefits

Comprehensive healthcare options

Company-paid time off

Retirement savings

Qualifications

• At least two years of directly related experience.
• Understanding of ISO 9001 guidelines.

Responsibilities

• Supports creation and retention of batch records and documentation.
• Monitors production procedures to ensure compliance with safety standards.
• Independently prepares and distributes production performance reports.

Skills

Attention to Detail

Organizational Skills

Teamwork

Education

Bachelor's degree in Natural Sciences

Job description

Who is USP?

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide.

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 hands-on, non-supervisory position working as a key member of the Reference Standards Production (RSP) team. The Production Quality Specialist plays a pivotal role in the production of USP Reference Standards (RS). The incumbent is responsible to prepare, review and issue required documentation and production instructions such as batch records, primary and secondary package labels, and change authorizations in accordance with company policies, quality systems. They are also responsible for providing real-time data to managers, generation of accurate reports, and rapid assessment of potential problems. The incumbent develops and manages systems and databases that are critical to the success of the department. The position is a critical component of USP’s core business and is expected to proactively support quality improvement and maintain USP’s culture of safety.

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 Associate Production Quality Specialist has the following responsibilities:

• Supports the creation, issuance, and retention of batch records, finished product labels and other documentation used in the production of all USP Reference Standards, in accordance with department SOPs and ISO 9001 guidelines.
• Manages label inventory, maintaining the accuracy and availability of printing supplies, through physical counts, inventory adjustments, and purchase requests, ensuring production demand is uninterrupted.
• Uses scientific judgement with Quality Assurance, Scientific, and Legal department staff to resolve discrepancies on documentation/labels and ensure that the labels created for use on USP Reference Standards meet all requirements and are error free.
• Develops and manages various department-level programs, including department forms review and revision, and tracking change control implementation, in a fast-paced team environment under constant deadline pressures.
• Monitors procedures of the entire production cycle to ensure they are efficient and comply with safety and quality standards, revising SOP’s and department forms as needed and using scientific judgment where applicable.
• Independently prepares and distributes production performance reports.
• Maintains relevant production-related documentation repository in Oracle database and performs other transactions in support of production-related activities.
• Investigates technical issues and seeks out resources to resolve them; provides training and technical guidance on label printers. Demonstrates a commitment to safety and seeks opportunities to promote USP’s culture of safety in the production environment.

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:

• Bachelor's degree in Natural Sciences (chemistry, biology, biochemistry) or related field with at least two (2) years of directly related experience, or an equivalent combination of training and experience.
• Understanding of ISO 9001 guidelines and quality systems.
• Readily learns new or specialty software applications.
• Highly organized, exceptional attention to detail, and a results-driven approach.

Additional Desired Preferences

• Skilled at establishing effective working relationships in a diverse team setting for the purpose of accomplishing departmental goals.
• Ability to work independently and meet deadlines, yet understands when to escalate issues, especially in urgent or complex situations. Ability to handle multiple priorities in a fast-paced environment.
• Proven capability to productively support internal and external clients. Must be a team player.
• Conveys a professional image through their actions.
• USP experience and/or experience in the pharmaceutical industry a plus. Familiarity with scientific/technical terminology preferred.
• Analyzing information, reporting research results, promoting process improvement, safety management.
• Takes personal responsibility to ensure work is delivered on time and is of the highest quality.

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 $32.31 – $41.03 per hour.
Target Annual Bonus: % Varies based on level of role.

Individual compensation packages are based on various factors unique to each candidate’s 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 notice from the Department of Labor.