Senior Production Lab Specialist

This position is with Stratix Labs a wholly owned subsidiary of U.S. Pharmacopeia (USP). Employment will be through Stratix Labs based in Minneapolis Minnesota with Stratix benefits and governed by its policies and procedures.

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 an onsite position based in Minneapolis MN supporting the important work of USPs microbiology operations manufacturing function within the microbiology business unit. The incumbent will work with the team primarily focused on the production and support tasks related to the production of microbial Analytical Reference Materials (ARMs) and reference standards. Successful applicants will anticipate and solve problems within their area of responsibility keep meticulous records and have good communication skills.

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 Senior Production Laboratory Specialist has the following responsibilities:

Reference Material Production: Directly engage in hands-on production activities of USP Analytical Reference Material.
o Perform microbial reference material production activities according to established SOPs.
o Perform incubations serial dilutions and enumeration of microbial samples.
o Prepare materials for production including sterilizing components preparing media assembling component packaging and material qualification.
o Ensure equipment is properly calibrated maintained and operated according to SOPs and test methods.
o Ensure production space is properly cleaned and maintained according to SOPs to ensure quality of production events.
o Fulfillment of finished goods Analytical Reference Material products.

Documentation & Compliance: Ensure meticulous and accurate documentation of all relevant paperwork.
o Adhere to all regulatory compliance regulations for good documentation practices.
o Ensure robust record keeping for production activities.
o Update logs and historical trend analysis.
o Assist QA/QC with production investigations.

Cross-Functional Support: Contribute to quality assurance/control process improvement initiatives and essential administrative tasks.
o Be an active participant in process improvement.
o Support QA/RA/QC with training and new process implementation.
o Assist R&D with new product introduction.

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 microbiology or relevant field.
Minimum of 3 years of relevant microbiology experience.
Proficient in excel word power point software applications.

Additional Desired Preferences

Experience related to microbiology or biological science.
Biological production experience.
A Quality by Design mindset for manufacturing.
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.

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 Hourly Range: USD $32.97 - $41.85 per hour.
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:

Senior IC