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Regeneron Pharmaceuticals Quality Compliance Coordinator in Troy, New York

The Quality Compliance Coordinator acts as initial point of contact for receiving and processing complaint notifications. They receive and process returned complaint samples and performs examination of complaint and reserve samples. They will also maintain compliance with site procedures and become involved as required to meet schedules or resolve problems.

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

  • Monitor complaint notifications from group mailbox

  • Enter complaint intake data into Process Compliance system and Complaint Master tracking sheet

  • Verify required documentation and content received

  • Evaluate and assign initial classification of event or complaint

  • Correspond with personnel and contractors (Call Center, Regeneron Distribution, Clinical Trial Management, etc.) as the need arises to request or obtain additional information related to complaint reports

  • Process receipt of complaint samples

  • Examine and evaluate complaint and retain samples for defects

  • Acquire photographic evidence, record sample data, enter observations and evidence into LIMS

  • Process complaint samples for destruction

  • Assist with delivery of complaint samples to QC for testing

  • Retrieve, copy/scan and maintain batch documentation used to support complaint investigations

  • Perform general administration activities in support of the complaint team

This role may be for you if you:

  • Excel in a quality driven organization

  • 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 BS/BA in scientific discipline or related field and the following minimum amounts of experience for each level:

  • Quality Compliance Coordinator: 3+ years

Relevant experience may be considered in lieu of degree.

#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 (hourly)

$23.89 - $37.36

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