The U.S. Pharmacopeial Convention (USP) Laboratory Informatics Analyst III in Rockville, Maryland
This is a non-supervisory position in the Central Laboratory Operations group of USP’s Global Laboratory Operations division. The incumbent will play a key role in support of many global and localized operational software needs, including oversight of software validation. The incumbent will work closely with other CLO and laboratory staff in the overall lifecycle management of analytical instrumentation and associated software. The group’s tasks include instrument and/or software procurement, performing on site software repair assessments, coordination and scheduling of vendor repair visits, and performing in-house repairs as needed. The incumbent is expected to utilize scientific, computing, engineering, and other skills to continuously monitor and improve the laboratory equipment systems and keep them operational. The group will also work on technical problems related to analytical instrumentation and software in multiple laboratories to ensure performance is suitable for use.
Roles and Responsibilities
Primary Superuser for various laboratory software within GLO laboratories (for example: Waters Empower, Waters LMS, Rees Environmental Monitoring System, Mettler Toledo LabX).
Performs basic troubleshooting of laboratory software systems.
Assists in software project planning and development across various laboratories.
Assist with implementation and monitoring of change control of laboratory software systems.
Performs software validation and integrated testing to prove acceptable performance.
Writes and performs execution of validation protocols and completed
Collaborates with QA and other CLO members to ensure software is maintained in compliance with ISO 9001 and 17
Bachelor’s degree in engineering, physical sciences or information technology with 6 years relevant laboratory and/or IT experience; OR, MS degree in engineering with 2 years relevant laboratory and/or IT experience, physical sciences or information technology; OR, 10 years of relevant laboratory and/or IT experience
4 years’ experience in software development, validation, qualification and/or testing
Familiarity with ISO 9001, ISO 17025 and/or cGXP quality programs
One year of supervisory or team lead experience
Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner
Ability to handle multiple priorities in a fast-paced environment
Excellent written and verbal communications skills
Able to work independently with limited supervision
Experience in the validation and/or qualification and/or testing of laboratory instrumentation software
Able to work flexible hours on occasion with advance notice
Knowledge of programming languages (g. SQL, VBA)
Knowledge of database theory background and experience
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) 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.
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