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Supervisor, Reference Standards Production

2 months ago

Frederick, Maryland, United States United States Pharmacopeia Full time
Job Title: Supervisor, Reference Standards Production

Join the United States Pharmacopeia team as a Supervisor, Reference Standards Production, and contribute to the development of quality standards for medicines, dietary supplements, and food ingredients.

About the Role:

This is a hands-on supervisory project management position in Reference Standards Production (RSP). As a Supervisor, you will be responsible for the project management and coordination of production activities in the production group. You will contribute to the expertise and work ethic of the production group through a broad range of technical support and knowledge.

Key Responsibilities:
  • Provide project management and direct supervision for the day-to-day operations of reference standard packaging and labeling.
  • Plan and prioritize production work to ensure departmental targets are met.
  • Interpret product specifications supplied by USP scientific staff to determine appropriate packaging configurations.
  • Support the deployment of EBR templates and batch records within RSP while also assisting to monitor change control within the software.
  • Collaborate with other USP groups and departments, such as QA and IT, to ensure that the EBR software is operational and functions in accordance with defined specifications and SOPs.
  • Responsible for accurate and timely production of USP Reference Standards according to USP best practices.
  • Manage the routine tasks of production while remaining alert for discrepancies and variations on the production line.
  • Serve as first line resource to troubleshoot technical issues, such as malfunctioning equipment, scheduling questions, or general issues.
  • Create, review, and approve production documentation for production projects.
  • Responsible for writing and revising departmental SOPs and technical documents.
  • Collaborate with validation staff in support of USP's quality goals.
Requirements:
  • Bachelor's degree in a related scientific field with three (3) years of direct experience in a production/laboratory environment or an equivalent combination of training and experience.
  • One year of experience supervising, leading teams, training, or mentoring other staff members is required.
  • Understanding of ISO 9001 guidelines, hazard communication, and quality systems required.
  • Candidate must be able to pass a pulmonary function test and be able to wear a N95 respirator.
  • Candidate may be exposed to blood-borne pathogens and should be immunized for Hepatitis B or receive the vaccination series from USP.
What We Offer:

USP provides a comprehensive benefits package, including company-paid time off, comprehensive healthcare options, and retirement savings. We are an equal opportunity employer and welcome applications from diverse candidates.