The U.S. Pharmacopeial Convention (USP) Quality Assurance IT Analyst I/II in Rockville, Maryland
This is a hands-on, non-supervisory, individual contributor position that supports the important work of USP’s Quality Assurance (QA) department. The incumbent will work independently, with some oversight, and will be primarily responsible for QA tasks related to the Information Technology aspects of USP’s online products and services; software; hardware and systems. The incumbent anticipates and solves problems and issues within his/her area of responsibility. In addition, the incumbent designs, develops and supports the implementation of new tools and techniques used in the overall Quality System at USP.
Roles and Responsibilities
Co-lead in Quality Management System programs, including investigations (i.e., CAPAs and deviations), participation in ISO 9001 certification and ISO 17025 accreditation activities, lead internal process/target audits, and providing training in Quality concepts and tools, and design/develop training materials and instructional materials.
Understand operational hardware and software configuration controls, system interfaces/dependencies for computer system(s) in order to analyze and troubleshoot system anomalies and ensure optimum hardware, software and systems performance as part of Quality Assurance investigations. This also includes the identification of vulnerabilities and suggestions for mitigation strategies.
Evaluate customer/stakeholder impact when hardware, software and systems changes are required that might affect USP’s online products and services and work with IT and other affected departments to manage the change.
Identify risks as part of Risk Management framework and gaps in system functionality and make recommendations for improvement(s). This includes all aspects of the project/product lifecycle from defining requirements to post-implementation support. This role is responsible for staying up to date on current technical trends and investigating techniques.
Act as a liaison to the GIS department and work closely with staff in Publications, GLO, Science and other departments as necessary to identify issues, investigate issues, identify root cause, develop corrective and preventive action plans and provide summary/trending reports.
Establish and maintain databases for tracking quality metrics. Analyze database information for trending and reporting purposes at pre-established frequencies including global trending data and analysis of Quality Management System metrics (e.g., audit results, non-conformances related to product and performance, results of investigations, customer complaints etc.) in order to make recommendations on opportunities for improvement.
Must be familiar with and adhere to security policy/manuals/standard operating procedures and other guiding policy documents in order to effectively manage changes and investigations.
Exercise discipline, effective communication, diagnose and resolve problems and providing detail oriented technical feedback utilizing a high degree of creativity, initiative and prioritization in a timely manner.
QA IT Analyst I
Bachelor’s degree in IT or scientific discipline
Two years of cross functional relevant experience in the areas of system administration, IT quality assurance, IT/System Support, or similar.
QA IT Analyst II
Bachelor’s degree in IT or scientific discipline
Four years of cross functional experience in the areas of system administration, IT quality assurance, IT/System Support, or similar.
Knowledge of Quality Assurance practices related to Information Technology activities. Experience working in a regulated environment (e.g., GMP, ISO) is preferred
Ability to work with minimal supervision in a dynamic environment and interact with different departments and staff at all levels of the organization in a collaborative manner
Demonstrated skills in audit techniques with previous ASQ CQA or lead auditor training experience is a plus
IT knowledge of systems, their interdependencies, risk identifications and QA mitigation strategies
General knowledge of Local Area Network (LAN) and Wide Area Network (WAN) technologies, data backup, monitoring technologies and disaster recovery activities
Ability to listen, interpret and explain complex information simply to audience, work well with diverse cultures and to influence without direct authority
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 Information Technology
Job Type Full-Time