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Associate QA Validation Specialist (Transport Qualification)

Job Description

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The Associate QA Validation Department at Regeneron is adding to their team! We are currently looking to fill several QA Validation Specialists in areas including

  • This team works closely with our Drug Manufacturing and Packaging Engineers to make sure our products are handled securely and not affected in transportation; a background in thermal dynamics is preferred

This area also validates the performance of the product transport system as well as the shippers required to safely deliver medicine to the patients.

The day to day of an Associate QA Validation Specialist could include, but are not limited to, the following:

  • Generating, implementing and/or reviewing master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria

  • Analyzing the results of testing and deciding the acceptability of results against pre-determined criteria

  • Investigating and troubleshooting problems which occur and determining solutions or recommendations for changes and/or improvements

  • Reviewing, editing and approving deviation notifications, deviation investigations, corrective actions, change controls, SOPs, reports and other documentation


This role might be for you if you:

  • Have validation or engineering experience in the pharmaceutical industry or similar industries

  • Can coordinate with other departments or outside contractors/vendors to complete validation tasks

  • Have experience with the packaging process of drug products

  • Have experience with the supply network of drug products

  • Continuously seek to improve processes for improved performance

  • Have hands on execution of validation studies

To be considered for this role you must hold a Bachelor’s degree in Engineering, Chemistry, or Life Sciences and the following years of relevant experience for each level:

  • Assoc. QA Validation Specialist : 0 – 2 years

  • QA Validation Specialist: 2+ years

May substitute proven experience for education requirement.

#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 - $89,300.00