The U.S. Pharmacopeial Convention (USP) (Associate) Production Quality Specialist in Frederick, Maryland
Summary of the Position
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.
Roles and Responsibilities
Leads 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.
Associate Production Quality Specialist:
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.
Production Quality Specialist:
Bachelor's degree in Natural Sciences (chemistry, biology, biochemistry) or related field with at least four (4) years of directly related experience, or an equivalent combination of training and experience.
High level of proficiency with office technologies and computer applications including MS Word, MS Excel, MS PowerPoint, MS Project, and Outlook required.
Familiarity with Oracle ERP
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.
Skilled at establishing effective working relationships in a diverse team setting for the purpose of accomplishing departmental goals.
Excellent verbal and written communication skills.
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.
USP offers an impressive benefits package, including:
Generous paid time off – 15 paid holidays, 10 sick days and 15 vacation days per year to start
An annual 401(k) contribution, beginning after 1 year of service, of 10% of pay (base and bonus) every pay period that vests immediately
Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles.
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
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.
The following COVID-19 provisions will apply to selected candidate(s) hired:
As a condition of employment with United States Pharmacopeial Convention’s (USP) duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after July 1st, 2021 are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
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 contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Laboratory/Production
Job Type Full-Time