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Quality Compliance Specialist (Complaints)

Employer
Regeneron Pharmaceuticals, Inc.
Location
Troy, New York
Start date
May 16, 2024

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Job Details

We are currently looking to fill a Quality Compliance Specialist (Complaints) position. This position maintains site compliance of operations focused primarily on investigation of product quality complaints received for commercially distributed and clinical products. This position conducts forensic review of evidence and both internal and external records, design of experiments to test hypothesis and writes technical reports to support investigation conclusions. Compliance Operations are inclusive of, but not limited to, Manufacturing (Internal and External), Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling and QA Validation, in accordance with mandated regulatory requirements and site expectations. This position acts as an advisor to these groups on how to maintain and improve compliance and becomes involved as required to meet schedules or resolve problems.

In this role, a typical day might include the following:

  • Responsible for ensuring aspects of Quality Compliance for the Rensselaer site inclusive of manufacturing, quality control, validation, facilities and materials management.

  • Conducts investigations related to dissatisfaction in product quality or performance by end user related to commercial and clinical products.

  • Researches complaints documentations, photograph evidence and evaluates return samples available to support complaint investigation.

  • Supports investigations and/or product complaints with focus on Root Cause Analysis (RCA).

  • Generates technical reports related to investigative findings, with supporting evidence.

  • Actively participates in company continuous improvement initiatives.

  • Participates in regulatory and customer audits.

  • Identifies gaps in systems and develops feasible plans for correction.

  • Other related responsibilities as assigned.

This role may be for you if you:

  • Are experienced in pharmaceutical or medical device complaint investigation

  • Have an understanding of biologics manufacturing operations

  • Are organized and have an attention to detail

  • Can prioritize multiple assignments and changing priorities

  • Are able to learn and utilize computerized systems for daily performance of tasks

To be considered for this role you must hold a Bachelors degree in scientific subject area or related field with the following amount of relevant work experience in pharmaceutical or related industry:

  • Associate Specialist - 0-2 years

  • Specialist 2+ years

  • Senior Specialist 5+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

#REGNQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$58,480.40 - $124,300.00

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
US

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