Associate QA Specialist (Quality Risk Management)

Location
Rensselaer, NY, United States
Posted
Jul 18, 2019
Ref
16967BR
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, 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: Responsible for supporting the work of Industrial Operations and Product Supply through the use of quality risk management (QRM). Job functions will primarily consist of the broad application of patient centered QRM across a full spectrum of processes vital to the operations of IOPS. Specifically, the active facilitation of quality risk assessments, risk reviews and other quality risk based programs supporting IOPS Quality System (e.g., change control, deviation management, etc.). The person in this role will be consistently challenged with assignments, touching almost every phase of our process. An understanding of QRM principles is essential.

JOB RESPONSIBILITIES:

• Providing technical expertise in quality risk management to a broad base of customers throughout the IOPS organization, including Quality Assurance, Quality Control, Manufacturing, Medical Device and Facilities.

• Facilitating data driven risk assessments and risk reviews.

• Formulating strategies for risk controls and mitigations.

• Preparing and revising QRM documents.

• Developing and improving the quality risk management program.

EXPERIENCE AND REQUIRED SKILLS:

• Requires BS/BA in the Biological Sciences, Chemistry, Biochemistry, Engineering or related field, and 0-2 years experience with manufacturing, development of manufacturing processes, or quality assurance.

*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, disability status, protected veteran status, or any other characteristic protected by law.
#LI-DF1