The U.S. Pharmacopeial Convention (USP) Quality and Investigations Lead in Rockville, Maryland

Quality and Investigations Lead

Tracking Code

1268-679

Job Description

Summary of the Position:

This is a hands-on, non-supervisory position where the incumbent manages quality investigations and reporting for the Publications Department. Investigations may be related to process or to content published in electronic or print form. The incumbent serves as liaison to the Quality Assurance department and works closely with staff in Publications, IT, and Science to identify issues, investigate issues, identify root cause and provide summary reports. This position also contributes to the overall quality of USP publications by ensuring that XML content supports the scientific integrity of the organization.

  • Primary Publications Department liaison with Quality Assurance (QA) Department. Partners with QA to identify, investigate, manage and report on documentary standards quality issues and market withdrawals.

  • Reviews complaint information and investigates origin and validity of complaint.

  • Leads investigation, identifying issue sources (root cause analysis), working across departments as needed, establishing corrections and corrective actions until completion.

  • Works with Science staff to evaluate the impact/risk of the confirmed complaint to the documentary standard product from a scientific perspective.

  • Generates, evaluates and reports metrics and trends related to product quality and productivity/turnaround time.

  • Escalates issues to management and QA as needed.

  • Maintains tracking database and runs reports regarding internal and external customer interactions.

  • Point of contact for internal and external customer interactions.

  • Suggests opportunities for improvement, development and training related to documentary standards development.

  • Point person for quality management system (Metricstream) assignments. Assigns and tracks action items.

  • Uses judgement to evaluate issues and make recommendations.

  • Prepares final reports.

  • Follows up on short-term and long-term corrective actions.

  • Reviews XML content for quality and accuracy.

  • Assists senior manager with creating and implementing quality systems.

  • Evaluates the need for and conducts sample-size testing across content and analyzes results.

  • Represents Publications Department in QA meetings, investigations and audits.

  • Coordinates and participates in XML file updates and corrections.

  • Performs other duties as required.

Basic Qualifications

  • Bachelor’s degree.

  • Minimum of 2 years of relevant experience in a quality assurance role.

  • Minimum of 2 years’ experience working in publications or communications.

  • An equivalent combination of education and experience is acceptable.

Preferred Qualifications

  • Knowledge of DITA XML file structure.

  • Knowledge of Content Management Systems.

  • Experience in a pharmaceutical, biotech or other regulated industry.

  • Quick learner and a team player with a proven time-management skills and ability to multi-task in a high-performance workplace.

  • Excellent facilitation, conflict resolution and team building skills.

  • Superior interpersonal skills: professionalism, accountability, helpfulness, delegation, and customer service.

  • Excellent verbal and written communication skills.

  • Excellent critical thinking and problem-solving skills.

  • Strong organizational skills and attention to detail.

  • Must have ability to think and operate independently to achieve results required for the job, understanding when and how to appropriately escalate issues.

  • Strong analytical and computer skills.

  • Prior experience in a deadline-driven publishing environment

  • Prior experience supporting cross-departmental projects preferred.

  • Must be proficient in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet).

  • Experience and comfort with statistical measurements (measuring and tracking quality, performance, etc.)

USP offers an impressive benefits package , including:

  • Generous paid time off – 13 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 ($250/individual or $500/family)

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.

Being a part of USP means belonging to a diverse culture made up of more than 1,000 talented professionals working together at five international locations. We share our expertise in science, IT, human resources, quality assurance, communications, administrative management, and more...all to support an overall mission dedicated to making a difference by providing standards and programs that help improve the quality of medicines, dietary supplements, and foods 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.

Job Location

Rockville, Maryland, United States

Position Type

Full-Time/Regular

Job Category Publications