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QA Specialist (QA for QC)

Employer
Regeneron Pharmaceuticals, Inc.
Location
Rensselaer, New York
Start date
May 17, 2024

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

Job Details

The QA department is hiring! The QA Specialist for QC applies functional knowledge in the Quality function. This individual will complete information analysis and assist in implementing industry standard processes for GMP across quality controls and laboratory areas. They will ensure that procedures, products, and documentation enforce to internal standards as well as those of the regulatory agencies.

As a QA Specialist, a typical day might include the following:

  • Interacts with Quality Control laboratories, support laboratories, and Facilities to ensure a successful compliance profile

  • Provides consultation or advice in alignment with QA policies

  • Active participation in investigation, evaluation, and problem resolution in support of Deviations, Change Controls, CAPAs, etc.

  • Performs activities associated with review, edit, and approval of QC generated documentation. Activities may be on the floor or at a desk

  • Collaborates with key partners in the business to proactively identify areas for improvement and develop solution strategies

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

  • Ensures safety and operational standards are maintained

This role may be for you if you have:

  • Good understanding of analytical laboratory and biologics manufacturing operations is helpful; experience with facility or laboratory start-up, technology transfer, or validation

  • Prior experience within a Quality Assurance or Quality Control function

  • Good interpersonal 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 apply computerized systems for daily performance of tasks

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

  • Experience in the pharmaceutical/biotechnology industry (biotech preferred)

To be considered for this position, you must hold a BS/BA in scientific subject area or related field and

  • Associate QA Specialist: 2+ years related experience

  • QA Specialist: 4+ years related experience

  • Senior QA Specialist: 6+ years relevant experience.

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 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 - $124,300.00

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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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
US

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