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.
Supports business user needs of the Regeneron Learning Management System (LMS) including creating user accounts, answering end user questions and training. Administers current LMS environment, develops new business opportunities and improves existing processes. Configures the Compliance Wire software to meet end-user needs. Processes system change control, documents configuration and writes test plans.
Level to be determined based on qualifications relevant to the role
Essential Duties and Responsibilities include, but are not limited to, the following:
Provides end-user support for the LMS (Compliance Wire) 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 LMS 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 LMS 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)
Provides LMS assistance prior to, during and post Regulatory/Partner inspections
Reviews company documentation including SOPs, SPECs, Batch sheets and/or Manufacturing Records to assess possible impact to LMS.
Works with Validation and Quality Assurance departments to ensure LMS is implemented following development life cycle approach.
Provides LMS customer support and training, troubleshoot problems, manage change control, and perform system maintenance;
Knowledge and Skills:
Knowledge of Crystal Reports and / or Business Objects desirable, but not required.
Knowledge of 21 CFR Part 11, Annex 11 Regulations and Good Manufacturing Practice (GMP) preferred.
Must show strong judgment and time management skills.
Ability to communicate at all levels with clarity and precision both written and verbally together with strong presentation skills.
Excellent interpersonal skills with strong customer service focus.
Ability to maintain integrity and honesty at all times.
Continuously drive to improve processes for improved performance.
Manage internal and external relationships.
Translate ambiguity into actionable steps.
May manage others through influence rather than direct authority.
Handle issues appropriately and with a sense of urgency.
Identify and effectively communicate risks.
Ability to problem solve and identify root cause
Education and Experience:
Associate Quality System Analyst: BS/BA in related field, may consider relevant experience in lieu of education
Quality System Analyst: BS/BA in related field, may consider relevant experience in lieu of education. Requires minimum of 2 years of relevant experience
Experience with Compliance Wire, or other enterprise Learning Management System experience preferred
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.