Associate Quality Systems Specialist

Rensselaer, New York, US
Jun 05, 2018
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.

Summary: The Associate QA Systems Specialist provides oversight of Quality Management System (QMS) implementation and use. The main objective is to perform QA review and approval of CAPA records, create and report CAPA system metrics, and leading or participating in continual improvement initiatives. This position will focus on the global CAPA system, but may support Change Controls, and Quality Risk Management elements of the QMS as well.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Reviewing system records for assignment and closure.
• Involved in daily operational activities such as monitoring status of system records, assisting users and record owners, and data trending for reporting metrics and for use in identifying continuous improvement initiatives.
• Assist Senior Quality Systems employees in support of maintaining, monitoring and improving quality system elements
This may include support in:
o Maintaining training content
o Assisting with the delivery of training, such as scheduling training sessions, maintaining rosters, and collecting feedback.
o Assisting with or conducting assessments to ensure systems are effective and efficient, well designed, and integrated with other QMS elements
o Monitor Process Performance over time
• Lead or participate in continual improvement initiatives
• Provides administration of electronic systems
• Assists as needed in audits and inspections.
• Contributes to ensure global harmonization of processes, procedures and methods.
• Author and /or revise SOPs

Knowledge, Skills and Abilities:
• Ability to take instruction, work in a team and in an individual capacity.
• Ability to develop relationships and coach business users on CAPA system requirements.
• Excellent written, oral, and interpersonal communication skills with ability to effectively interact with a broad spectrum of audiences.
• Knowledge of quality and cGMP principles and systems and relevant regulatory guidelines.
• Exhibiting a drive for results, dealing with ambiguity, learning on the fly, and individual courage.
• Excellent time and project management skills with the ability to manage many diverse tasks simultaneously.
• Strong attention to detail.
• Effectively organize and manage work responsibilities under general guidance.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Working knowledge of Microsoft Project and SharePoint is a plus.

Education and Experience:
• Requires a minimum BA/BS degree with 0-2 years of industry/relevant experience or MS with 0-1 year. Will substitute relevant experience for education.

*Level will be determined based off education 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, disability status, protected veteran status, or any other characteristic protected by law.

Requisition Number: 13526BR