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Quality Compliance Specialist (Complaints)

Job Description

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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. Conducts forensic review of evidence and records, design of experiments to test hypothesis and writes technical reports to support investigation conclusions. Compliance Operations including but not limited to Manufacturing (Internal and External), Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, QA Validation in accordance with mandated regulatory requirements and site expectations. Acts as an advisor to these groups of how to maintain and improve compliance.

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

  • Ensuring aspects of Quality Compliance for the site including manufacturing, quality control, validation, facilities, and materials management

  • Conducting investigations related to dissatisfaction by end user related to commercial and clinical products

  • Researching complaints documentations, photograph evidence and evaluate return samples to support complaint investigation

  • Generating technical reports related to investigative findings, with supporting evidence

  • Participating in regulatory and customer audits

  • Identifying gaps in systems and develop feasible plans for correction

  • Actively participating in continuous improvement initiatives

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 Bachelor’s degree in scientific subject area and the following minimum amount of experience for each level:

  • Quality Compliance Specialist: 2+ years
  • Sr. Quality Compliance Specialist: 5+years

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

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$65,100.00 - $124,300.00