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QA Validation Specialist - Document Review

Employer
Regeneron Pharmaceuticals, Inc.
Location
Troy, New York
Start date
Apr 6, 2024

View more

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

Job Details

The QA Validation Oversight department is hiring! This team leads all aspects of documentation for validation areas across the business, including QC, Process Sciences, operations, CSV, gene and cell therapy, tech transfers and transfer of products.

As a QA Validation Specialist-Document Review, a typical day might include the following:

  • Reviewing and providing quality oversight of results of validation activities, including, but not limited to: Shipping, Equipment, Computerized Systems, QC methods and process.

  • Generating, implementing and/or reviewing master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria

  • Reviewing the results of testing and determining the acceptability of results against pre-determined criteria.

  • Investigating and troubleshooting problems and providing recommendations for changes and/or improvements.

  • Reviewing, editing and approving deviation notifications, deviation investigations, corrective actions, change controls, SOPs, reports and other documentation

  • Coordinating with other departments or outside contractors/vendors to complete validation tasks.

  • May supervise, provide direction and assign work to Validation Specialists and/or contingent workers to meet goals and timelines.

This role may be for you if you:
  • Maintain integrity and honesty at all times

  • Can work independently or as part of a team

  • Communicate with transparency

  • Continuously drive to improve processes for improved performance

  • Demonstrate supportive behavior at all times

  • Have basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)

  • Gather and organize information while meeting commitments on time

  • Perform well-defined tasks

  • Have effective time management skills

To be considered for this position, you must hold a BS/BA in Engineering, Chemistry, or Life Sciences and:

  • QA Validation Specialist: 2+ years of relevant experience

  • Sr. QA Validation Specialist: 5+ years of relevant experience

May substitute proven experience for education requirement

A background in Quality Control, Process Sciences and/or manufacturing/lab equipment in a pharmaceutical setting is preferred.

#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)

$65,100.00 - $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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