QA Specialist (Clinical Packaging and Labeling)

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Job description

The QA Clinical Packaging and Labeling team is hiring! The QA Specialist performs activities in support of dispositioning product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. This position works closely with Clinical Pack and Label Contract Manufacturing Organizations.

In this role, a typical day may include:

• Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution

• Review and approval of investigations associated with, product, laboratory, facilities, and materials.

• Train and/or mentor junior employees, including providing insights and education on processes and procedures

• Provides consultation or advice in alignment with QA policies

• Perform activities associated with disposition of raw materials and product (e.g., receipt, inspection, document review, shipping, etc.).

• Activities performed at desk with occasional travel

• Review, edit, or approve Regeneron controlled documents

• Perform status labeling of raw materials and product

• Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement

This role may be the right fit for you if you have:

• Understanding of biologics manufacturing operations and packaging operations is helpful

• Good organizational skills and attention to detail

• Ability to handle multiple assignments and changing priorities

• Ability to learn and use computerized systems for daily performance of tasks

• Ability to prioritize, lead multiple tasks, and meet deadlines

• Ability to work a varied schedule including off shift and weekends

To be considered for this role, you must hold a Bachelor's degree and the following minimum amount of relevant experience for each level:

• QA Specialist: 4+ years

• Sr. QA Specialist: 6+ 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 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)

$69,300.00 - $132,200.00

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