QA Validation Specialist – Document Review

Regeneron Pharmaceuticals, Inc (USA)

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

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