Quality Compliance Specialist (Material & Supplier Quality)

Location
Rensselaer, New York
Posted
Mar 30, 2018
Ref
12271BR
Required Education
Associate 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, 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: Leads compliance related activities, such as investigations, change controls, CAPA, etc. across all areas within an area of QA such as QA Raw Materials, Material & Supplier Quality, etc.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Ensures that all activities related to the investigation and resolutions of non-conformities are performed in a timely manner and in compliance with Regeneron procedures and regulatory requirements.
• Leads and participates directly in the investigation process.
• Writes and/or reviews investigation reports.
• Ensures Corrective & Preventative Actions are appropriate, are implemented as planned and have the intended effectiveness.
• Identifies recurring events and ensures appropriate actions are taken, such as Management notification.
• Keeps team members informed of the status of assigned work.
• Leads and manages Change Controls for Material & Supplier Quality.
• Other activities associated with tracking of projects, deviations, change controls, etc. as assigned by QA management.

Knowledge, Skills and 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.
• Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint).
• Gathers and organizes information.
• Meets commitments on time.
• Follows directions; performs well-defined tasks.
• Effective time management skills.
• Seeks to identify continuous improvement needs.
Education and Experience:
• For Associate Level - BS in chemistry, biology or related field with a minimum of 1 year relevant experience in raw material and supplier quality, or leading investigations/change controls in a cGMP environment.
• For Mid Level - BS in chemistry, biology or related field with a minimum of 3 years relevant experience in raw material and supplier quality, or leading investigations/change controls in a cGMP environment.
• For Senior Level - BS in chemistry, biology or related field with a minimum of 5 years relevant experience in raw material and supplier quality, or leading investigations/change controls in a cGMP environment.
• Will consider Bachelor's degree in other discipline with relevant experience.

*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.

Requisition Number: 12271BR