Supervisor, Reference Standards Production at United States Pharmacopeia

Description

Who is USP?

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our workan environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

Brief Job Overview

This is a hands-on supervisory project management position in Reference Standards Production (RSP). In this role, the Supervisor will be responsible for the project management and coordination of production activities in the production group and is expected to contribute to the expertise and work ethic of the production group through a broad range of technical support and knowledge. Additionally, this role will support localized operational software needs, especially related to the development and maintenance of the Electronic Batch Record (EBR) software. This position will make critical decisions,

is a component of USPs core business and is expected to collaborate on departmental quality initiatives and actively support USPs culture of safety.

How will YOU create impact here at USP?

In this role at USP, you contribute to USP's public health mission of increasing equitable access to high quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.

The Supervisor, Reference Standards Production, has the following responsibilities:

Reference Standards Production

• 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. Serve as a liaison to scientific staff to ensure appropriate implementation of specifications and resolution of deviations and investigations. Develop and utilize expertise to serve as a resource for department staff.
• Support the deployment of EBR templates and batch records within RSP while also assisting to monitor change control within the software.
• Collaborates 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. This includes understanding of package configuration requirements and batch record instructions; safe handling of chemical products in the production environment; proactive support of contaminate prevention; and remaining focused on team commitments and communication.
• Manages the routine tasks of production while remaining alert for discrepancies and variations on the production line. Reports all discrepancies to RSP Manager to prevent hazards and/or loss of production volume.
• Serves as first line resource to troubleshoot technical issues, such as malfunctioning equipment, scheduling questions, or general issues as well as a resource for technical documentation issues.
• Create, review, and approve production documentation for production projects, working under pressure to generate product that meets QA and ISO standards.
• Responsible for writing and revising departmental SOPs and technical documents.
• Collaborates with validation staff in support of USPs quality goals.

General

• Demonstrates a commitment to safety and seeks opportunities to promote USPs culture of safety in the production environment. Maintain safety standards in the production environment and respond appropriately to chemical or mechanical hazards.
• Demonstrates a strong desire to learn, develop professional skills, and grow personal capability.
• Takes personal ownership of work assigned, continuing to meet production targets while prioritizing additional responsibilities.
• Works with internal clients, manages projects effectively, and ensures impeccable work-product delivery.
• Assists in the accomplishment of key departmental metrics.
• Plan and execute process improvement projects.
• Performs other related duties as assigned.

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:

Education and Experience:

• Qualified candidates will possess a bachelors 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. An equivalent combination of education and experience is acceptable.
• 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. The candidate may also choose to decline vaccination while still performing the required job duties.

Knowledge, Skills, and Abilities:

• Skilled at establishing effective working relationships in a team setting.
• Strong communication and presentation skills, written and verbal. Strong ability to demonstrate technical information to peers and internal audiences.
• Able to establish effective relationships across various departments to meet USP-level goals. Excellent facilitation, conflict resolution, and team building skills in the management of cross functional activities.
• Well-developed organizational, interpersonal communication and team building skills.
• Skill to anticipate, trouble shoot and solve technical problems in a production/manufacturing environment.
• Able to work independently yet understands when to escalate issues to senior staff.
• Ability to build technical expertise in others by serving as a role model and mentor.
• Experience promoting laboratory safety and responding to chemical spills required.
• Takes personal responsibility to ensure work is delivered on time and is of the highest possible quality

Additional Desired Preferences

• Familiarity with the pharmaceutical industry, the uses of Reference Standards, EBR software and with official compendia preferred.
• Prior experience in a pharmaceutical manufacturing organization is a plus.
• Practical experience in team leadership, training or mentoring peers is preferred.
• Experience working in the pharmaceutical and/or biotechnology industry strongly preferred.
• Working knowledge of relevant computer applications (MS Office suite, Oracle) preferred.

Supervisory Responsibilities

• 7 direct reports; (Associate) Production Laboratory Technicians

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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)

Job Category Chemistry & Scientific Standards

Job Type Full-Time