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QA Specialist (Clinical Packaging and Labeling)

Job Description

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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 the following knowledge, skills, and abilities:

  • Understanding of biologics manufacturing operations and packaging operations is helpful

  • Good organizational skills and attention to detail

  • Requires good written, verbal, and interpersonal communication skills and the ability to effectively interact cross functionally

  • 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.

#REGNQA

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)

$69,300.00 - $132,200.00