The U.S. Pharmacopeial Convention (USP) Laboratory Systems and Informatics Supervisor in Rockville, Maryland
Summary of the Position
This is a hands-on supervisory role in the Central Laboratory Operations (CLO) department within the Global Laboratory and Technical Operations (GLTO) division. The incumbent will lead a group with the responsibility of maintaining laboratory software and associated computer hardware in an operational and validated state as per ISO 17025 requirements. This includes overseeing the development, installation, computer system validation (CSV), and continued operation of excel-based spreadsheets, electronic notebook forms, chromatographic custom fields, and other laboratory software.
Roles and Responsibilities
• Supervise, develop, and mentor Laboratory Systems and Laboratory Informatics staff by scheduling and coordinating priorities and tasks to ensure continuing operations
• Respond to and manage internal customer troubleshooting requests for hardware, networking and software issues related to laboratory software systems by ensuring prompt closure of open tickets
• Plan, schedule, draft, execute, review and approve software validation protocols either in-house or through vendors including the creation, revision, and validation of spreadsheets, custom fields and forms used for laboratory calculations.
• Collaborate with QA, IT, facilities, laboratories, and other CLO staff to ensure software is maintained in a validated state and is in compliance with ISO 9001 and 17025 requirements including updating procedures and processes and documentation deviations and CAPAs.
• Manage the building, testing, and deployment of associated new laboratory computer hardware.
• Testing, validating, and documenting updates, patches, upgrades and changes made to laboratory hardware, firmware, and software.
• Bachelor’s degree in engineering, physical sciences or information technology with 6 years relevant laboratory IT experience; or Master’s degree with 4 years relevant laboratory IT experience; or 10 years of relevant laboratory IT experience
• Familiarity with ISO 9001, ISO 17025 and/or cGXP quality programs
• Supervisor or team lead experience
• Computer systems validation (CSV) experience including excel based forms utilizing visual basic
• In-depth laboratory computer hardware troubleshooting skills
• Experience with the following software packages: Waters Empower, Waters NuGenesis Lab Management System (LMS), Waters NuGenesis SDMS, Rees Environmental Monitoring, and LabX software.
• Deep knowledge and understanding of GAMP 5, 21 CFR part 11, ASTM 2500, USP <1058>, ISO 9001 and ISO 17025 requirements
• Applied knowledge of SQL databases
• Able to work flexible hours when needed. In addition to normal business hours of 8:30 a.m. 5:00 p.m. Monday through Friday, serves on a team to provide 24 hour a day, 7 days a week response to emergency alarm calls and can be available on short notice to support requests during unusual hours, especially early or late in the day during the business week.
Manage 2-3 Laboratory Systems Engineers and
Manage 2-3 Laboratory Informatics Engineers
USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.
The U.S. Pharmacopeial Convention (USP) 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.
COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired:
As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully present 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 Chemistry & Scientific Standards
Job Type Full-Time