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Sr QA Specialist (Supervisor) - Raw Materials

Job Description

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We are currently looking to fill a Sr. Quality Assurance Specialist (Supervisor) position for Raw Materials and Fill/Finish. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Quality Assurance Specialists support the disposition of raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

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

  • Performing activities associated with disposition of raw materials, primarily components used in fill/finish, (e.g. receipt, inspection, document review, exception status application/labeling, etc.), activities are mainly at a desk but may require going to the floor.

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

  • Reviewing/editing Regeneron controlled documents

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

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

  • Supporting Regeneron compliance instances (NOE, SCAR) when needed

  • Providing consultation or advice in alignment with QA policies

  • Provides hands on leadership to employees

  • Ensures employee timesheets are completed on time

  • Participates with employee training to ensure that all requirements are met

  • Performs monthly performance feedback meetings with direct reports

  • Raises all performance issues to Manager and/or Directors and/or HR

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

  • Enjoy working with people in a supervisory capacity

  • Are able to lift up to 50 lbs

  • Are comfortable occasionally working in a warehouse environment

To be considered for the Quality Assurance Specialist role, you must hold a Bachelor’s degree and the following years of experience for each level.

  • Sr. QA Specialist: 6+ years

May substitute proven experience for education requirement.

#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)

$76,100.00 - $124,300.00