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Job Details

Laboratory Informatics Specialist III/IV

Company name
The United States Pharmacopeial Convention

Location
Rockville, MD

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Profile

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, especially as related to the development, implementation, and maintenance of the Electronic Laboratory Notebook (ELN) and associated components.  The incumbent will also be expected to contribute to the work ethic of the laboratory through a broad range of technical support and knowledge.

Roles and Responsibilities:

Develop enhancements and new uses to the functionality of software systems, with the inclusion of new processes and/or procedures, in particular with respect to Electronic Laboratory Notebook (ELN).

Deploy of ELN forms to multiple laboratories and sites of USP.

Primary Super user for various laboratory software within GLO laboratories (for example: Waters Empower, Electronic Laboratory Notebook, Rees Monitoring, and LabX).

Performs basic troubleshooting of laboratory software systems.

Performs basic training of system end users.

Monitor the systems to confirm optimal performance and timely discovery of variances.

Perform software purchase, installation, and maintenance programs to support GLO laboratories.

Ensure all software/instrument systems are operational and functions in accordance to defined

Assists with software project planning and development across various laboratories.

Assists with implementation and monitoring of change control of laboratory software systems.

Performs software validation and integrated testing to prove acceptable performance.

Assists IT with system back-up processes to ensure continuity of services.

Assists with operation controls of the system to maximize software functionality and comply with regulatory requirements.

Assists with local system maintenance to prevent disruptions of service due to loss of hardware or software functionality.

Performs data entries and maintenance of ELN project management, equipment, and inventory

Assists in collaboration with other USP groups and departments, such as QA and IT, to ensure that laboratory software are properly functional and that all necessary environmental conditions are acceptable.

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

Basic Qualifications:

Laboratory Informatics Specialist III: 

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

Laboratory Informatics Specialist IV: 

Bachelor’s degree in engineering, physical sciences or information technology with 8 years relevant laboratory and/or IT experience; OR, MS degree in engineering with 6 years relevant laboratory and/or IT experience, physical sciences or information technology; OR, 12 years of relevant laboratory and/or IT experience

Preferred Qualifications 

Laboratory Informatics Specialist III: 

Six years of experience in the validation and/or qualification and/or testing of laboratory instrumentation software

Six years of experience working within ISO 9001, ISO 17025, or cGMP quality programs.

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.

Able to work flexible hours on occasion with advance notice

Strong written and verbal communication skills

Strong analytical skills

Some knowledge of SQL, VBA or other programming languages

Some knowledge of Oracle or other databases as a developer, analyst or data modeler

Laboratory Informatics Specialist IV: 

Eight years of experience in the validation and/or qualification and/or testing of laboratory instrumentation software

Eight years of experience working within ISO 9001, ISO 17025, or cGMP quality programs.

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.

Able to work flexible hours on occasion with advance notice

Strong written and verbal communication skills

Strong analytical skills

Experience with both SQL and VBA programming languages

Experience with Oracle databases as a developer, analyst or data modeler

Experience with Waters Electronic Lab Notebook as a Forms Developer

Supervisory Responsibilities 

No

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 Requirements

Company info

The United States Pharmacopeial Convention
Website : http://www.usp.org/

Company Profile
The United States 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 developed and relied upon in more than 140 countries.

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