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QA Specialist (Record Review)

Employer
Regeneron Pharmaceuticals, Inc.
Location
Rensselaer, New York
Start date
Sep 30, 2022

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Discipline
Clinical, Clinical Medicine, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work
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Job Details

We are currently looking to fill a Quality Assurance Specialist position. This position performs activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

Available Work Schedules:

Monday-Friday, 8:00am-4:30pm

Monday-Friday, Noon-8:30pm

In this role, a typical day might include the following:
•    Representing Quality Assurance in support of sophisticated Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
•    Participate as a QA representative on Technology Transfer Startup Teams where responsibilities include providing guidance on QA procedures and polices as well as review of documents for both internal and external transfers
•    Providing consultation or advice in alignment with QA policies
•    Reviewing completed records and batch sheets and working with other departments and communicate internally (Tarrytown, Raheen) and externally effectively
•    Performing activities associated with disposition of product (e.g. document review, shipping), activities may be on the floor or at a desk
•    Reviewing, editing, or approving Regeneron controlled documents
•    Performing status labeling of product
•    Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement

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
•    Can prioritize multiple assignments and changing priorities
•    Are able to learn and utilize computerized systems for daily performance of tasks

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

  • QA Associate – 0-2+ years

  • Associate QA Specialist – 2+ years

  • 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 steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.

#REGNQA #LI-Hybrid

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Find Us
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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