Compliance Specialist (Quality Control - Filling)

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: Responsible for assisting Quality Control laboratories with investigations, deviations, method changes and document workflows as needed by specific functions including Chemistry, Bioassay, Microbiology and Virology.

Level to be determined based on qualifications relevant to the role

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

• Ensure 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.

• Lead and participate directly in the investigation process.

• Write and/or review investigation reports.

• Contribute in cross-functional meetings to conduct root-cause analysis and determine corrective and preventative actions.

• Assist in the execution of Corrective & Preventative Actions and ensure they are appropriate, effective, and are implemented as planned in a timely manner.

• Identify recurring events and trends within Quality Control's deviations and propose continuous improvement ideas based on findings.

• Keeps team members informed of the status of assigned work.

Education and Experience:

• Assoc Specialist: BS/BA in chemistry, biology or related field

• Specialist: BS/BA in chemistry, biology or related field with 2 years of experience in quality control/analytical sciences including minimum of 1 year of experience leading lab investigations in a cGMP environment

• Sr Specialist: BS/BA in chemistry, biology or related field with 5 years of experience in quality control/analytical sciences including minimum of 1 year of experience leading lab investigations in a cGMP environment

• Or equivalent combination of 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.
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