Quality Compliance Coordinator (Quality Systems)

Location
Rensselaer, NY, United States
Posted
Mar 12, 2019
Ref
15955BR
Required Education
Bachelors Degree
Position Type
Full time
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: The Quality Systems Coordinator supports data trending, process monitoring, and system administration activities to ensure overall good health of the Quality Management System (QMS) This position will focus on CAPA, Change Control, and Quality Risk Management elements of the QMS.

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

• 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 Conduct assessments to ensure systems are effective and efficient, well designed, and integrated with other QMS elements

o Monitor Process Performance over time

• Participate in continuous improvement initiatives

• Provides administrative support of electronic systems

• Assists as needed in audits and inspections.

• Contributes to ensure global alignment of processes, procedures and methods.

• May author and /or revise SOPs

Knowledge, Skills & Abilities:

• Ability to maintain integrity and honesty at all times

• Ability to work independently or as part of a team

• Ability to communicate with transparency

• Continuously drive to improve processes for improved performance

• Demonstrate respectful behavior at all times

• Ability to learn and follow routine procedures independently

• Basic troubleshooting skills

• Identify and communicate continuous improvement ideas

• Ability to work in an every-changing environment

• Build and maintain working relationships

• Goes above and beyond by demonstrating proficiencies with assigned tasks

• Ability to gather, generate, and interpret data

• Participates in projects

Education and Experience:

• Requires a minimum BA/BS degree with 0-2 years of industry/relevant experience or MS with 0-2 years.

• Relevant experience may be considered in lieu of degree.

*Level will be determined by education and 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.