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QA Validation Specialist (CSV)

Job Description

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The QA Validation Specialist for Computer Systems validates and qualifies equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.

In this role a typical day might include the following:

  • Generates, executes and/or reviews master and completed computer system(s) qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria

  • Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.

  • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.

  • Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.

  • Reviews, edits and approves change controls, SOPs, reports and other documentation

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

  • Manages projects and prepares status reports.

This role may be for you if you have:

  • Knowledge in GAMP, 21 CFR PART 11, Annex 11

  • Ability to maintain integrity and honesty at all times

  • Ability to work independently or as part of a team

  • Ability to communicate with transparency

  • Continuously drive to improve processes for improved performance

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

  • Gathers and organizes information

  • Meets commitments on time

  • Follows directions; performs well-defined tasks

  • Effective time management skills

In order to be considered for this position, you must hold a BS/BA in Engineering, Chemistry, Life Sciences, Computer Science, IT or related field and

  • Associate QA Validation Specialist: 0-2 years of related experience within the field preferred

  • QA Validation Specialist: 2-5 years of related experience within the field preferred

  • Senior QA Validation Specialist: 5+ years of related experience within the field preferred

  • May substitute relevant experience for education.


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)

$55,700.00 - $121,300.00