Quality System Analyst - ValGenesis

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Supports business user needs of the Regeneron EVMS (Electronic Validation Management System) including creating user accounts, answering end user questions and training. Administers current EVMS environment, develops new business opportunities and improves existing processes. Configures the EVMS (ValGenesis) software to meet end-user needs. Processes system change control, documents configuration and writes test plans.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Provides end-user support for EVMS (ValGenesis) including troubleshooting problems at the application and server level.

• Effectively identifies and resolves system issues and appropriately communicates items to management, business process owner and users

• Performs daily business administrative tasks related to functional support and general user account administration.

• Provides SME support and works closely with functional departments on EVMS projects to develop, implement and enhance the system

• Assists System Administrator with problem solving and implementation of solutions.

• Demonstrates the ability to perform detail-oriented work with a high degree of accuracy.

• Supports and maintains system processes, procedures and controls for EVMS ensuring compliance with current Good Manufacturing Practices (cGMP)

• Produces reports/generates data as requested.

• Processes system change requests ensuring the systems validated state is maintained (development of requirement specs, design specs and test plans)

• Provide EVMS assistance prior to, during and post Regulatory/Partner inspections

• Review of company documentation including SOPs, SPECs, Batchsheets and/or Manufacturing Records to assess possible impact to EVMS.

• Works with Validation and Quality Assurance departments to ensure EVMS is implemented following development life cycle approach.

• Provide EVMS customer support and training, troubleshoot problems, manage change control, and perform system maintenance;

Education and Experience:

• BS/BA in related field and minimum 2 years of relevant experience, ValGenesis, or other enterprise Electronic Validation Management System experience preferred.

• Relevant experience may be considered in lieu of education.

• Knowledge of Crystal Reports and / or Business Objects desirable, but not required.

• Knowledge of 21 CFR Part11, Annex 11 Regulations and Good Manufacturing Practice (GMP) preferred.

*Level will be determined based on skills and related experience.*

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.