Quality Compliance Specialist (Complaint Investigation)

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 investigation of product quality complaints received for commercially distributed and clinical products. Includes compilation and presentation of complaint data, requesting and tracking investigations from Regeneron CMO and Partner organizations, and addressing internal and external requests for data.

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

• Request investigations from CMO and partner organizations. Monitor progress and coordinate receipt of completed investigation reports.

• Perform analysis of complaint data for routine and spontaneous requests.

• Generate cohesive and comprehensive reports.

• Field internal/external data requests and collaborate with the requestor to provide the appropriate data in compliance with regulations and Regeneron procedures.

• Work with Sample Management for investigative and annual retains reviews.

• Generate and review investigation reports and data summaries in support of individual complaint investigations.

• Actively participate in continuous improvement initiatives.

• Prepare written reports to management on findings and is integral in the process of developing corrective and preventative actions associated with findings.

Knowledge, Skills, and Abilities:

• Routinely demonstrates clear and direct written and verbal communication

• Ability to multi-task is critical

• Ability to learn and apply new concepts

• Ability to work within a team

• Ability to employ critical thinking

• Ability to anticipate and identify problems and to develop solutions

• Ability to adapt to change

• Ability to accept ambiguity

Education and Experience:

• Quality Compliance Specialist Level - Bachelors degree and 2-5 years of experience

• Sr Quality Compliance Specialist Level - Bachelors degree and 5+ years of experience

• Educational background or relevant work experience in performing data analysis and trend reporting required

• Experience with database systems for data mining and software tools (e.g. excel) for performing analysis

• Lab data systems (e.g., LIMS) and Process Compliance software experience a plus

• Experience working in a GMP environment

• Relevant experience may be considered in lieu of educational 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.
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