Quality Control Analyst II

Who is USP

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds 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 1300 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 mindsregardless of backgroundto 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 position that supports the important work of USPs microbiology operations team within the microbiology business unit. The incumbent will work independently with some oversight and will be primarily responsible for quality control (QC) tasks related to the production of microbial Analytical Reference Materials (ARMs) and reference standards. The incumbent anticipates and solves problems and issues within his/her area of responsibility.

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 USPs 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 Quality Control Microbiologist has the following responsibilities:

• Lead quality control microbiology testing at the USP St. Paul MN site.
• Perform microbial culture assays on solid agar media.
• Perform serial dilutions of microbial suspensions.
• Perform incubation and enumeration of microbial samples on solid culture media.
• Support operations product release testing of USP Analytical Reference Materials.
• Coordinate microbial identity testing (DNA sequencing and MALDI-TOF) with external microbiology test lab.
• Manage and lead product stability testing for USP Analytical Reference Materials.
• Support R&D testing for new product introductions.
• Interpret data identify trends and report findings to relevant personnel.
• Ensure equipment is properly calibrated maintained and operated according to SOPs and test methods.
• Contribute to the development and refinement of quality control test methods procedures and related SOPs.
• Adherence to relevant regulatory guidelines where applicable such as Good Manufacturing Practices (GMP) Good laboratory Practices (GLP) and International Organization for Standardization (ISO).

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:

• Bachelors degree in a science field and a minimum of 2 years of relevant quality control experience in a pharmaceutical or other regulated industry.
• Minimum of 2 years of relavent microbiology experience.
• Proficient in excel word power point software applications.

Additional Desired Preferences

• Experience related to microbiology or biological science.
• Quality control testing experience.
• Advanced understanding of ISO 9001/ ISO 17034 and ISO 17025.
• Knowledge of use of USP Compendia (Monographs General Chapters).
• Knowledge of FDA regulations other Compendia and ICH guidelines.
• Ability to listen interpret and influence without direct authority in a cooperative and friendly manner.
• Detail oriented with well-developed organizational and prioritization skills.
• Results and timeline driven with demonstrated successful outcomes.
• Ability to handle multiple priorities and shift priorities as a result of a fast-paced environment.
• Excellent written and verbal communications skills.
• Well-developed presentation skills.
• Demonstrated excellent verbal and written communication skills.
• Ability to explain complex information simply to a diverse audience.
• Experience on research and development instrumentation techniques and analytical skills.

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 $74000.00 $94000.00 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.

Required Experience:

IC