Associate Quality Compliance Specialist (Complaints)
Job Description
We are currently looking to fill an Associate Quality Compliance Specialist to support our Post Marketing Surveillance Retain Sample team! This position maintains site compliance of operations focused primarily on investigation of product quality complaints received for commercially distributed and clinical products.
In this role, a typical day may include the following:
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Responsible for ensuring aspects of Quality Compliance for the Rensselaer site inclusive of manufacturing, quality control, validation, facilities and materials management.
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Conducts investigations related to dissatisfaction in product quality or performance by end user related to commercial and clinical products.
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Researches complaints documentations, photograph evidence and evaluates return samples available to support complaint investigation.
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Supports investigations and/or product complaints with focus on Root Cause Analysis (RCA).
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Generates technical reports related to investigative findings, with supporting evidence.
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Actively participates in company continuous improvement initiatives.
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Participates in regulatory and customer audits.
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Identifies gaps in systems and develops feasible plans for correction.
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Other related responsibilities as assigned.
This role may be for you if you:
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Excel in a quality driven organization
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Have an understanding of biologics manufacturing operations
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Are organized and have an attention to detail
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Can prioritize multiple assignments and changing priorities
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Are able to learn and utilize computerized systems for daily performance of tasks
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Have previous experience in QA and/or Drug Product Filling preferred
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To be considered for this role you must hold a Bachelorβs degree and the following amount of relevant experience for each level:
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Associate Quality Compliance Specialist β 0-2 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)
$59,700.00 - $91,100.00
Date Posted
12/06/2024
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