Sr. QA Specialist

Rensselaer, New York, US
Jul 13, 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, 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: Performs and leads activities in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

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

• Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution,

• Represents the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and procedures; liaise with external partners and provide input on regulatory communications.

• Train and/or mentor junior employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization;

• Provides consultation or advice in alignment with QA policies;

• Perform activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc.). Activities may be on the floor or at a desk.

• Review, edit, or approve Regeneron controlled documents.

• Review and approve investigations associated with raw materials, product, laboratory, facilities, or materials.

• Perform status labeling of raw materials and product.

• Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement.

• Reviews internal and external requirements and implements required processes, as needed, to meet expectations regarding Quality.

• Collaborates with functional departments to resolve issues.

Knowledge, skills, and abilities:

• Coordinate, organize and assign daily activities of operations.

• Continuously drive to improve processes for improved performance.

• Support employees, executing against established guidelines and common procedures and policies.

• Ability to effectively manage high-stress situations.

• Strong leader and teacher.

• Demonstrated flexibility during ambiguous situations.

• Ability to identify problems and escalate accordingly.

• Understanding of biologics manufacturing operations is preferred.
Education and Experience:

• Requires BS/BA in scientific discipline or related field and minimum 6 years relevant experience.

• Relevant experience may be substituted for education requirement.

*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.