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QA Validation Specialist (Oversight)

Job Description

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The QA Validation Oversight department is hiring! This team supports validation of equipment, utilities, software, cleaning and sterilization processes at Regeneron’s Rensselaer facility in accordance with regulatory requirements implementing company manufacturing standard policies and procedures.

In this role, a typical day may include:

  • Generates, executes and/or reviews master and completed 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.

  • Investigation and troubleshooting problems which occur during validations and determines solutions or recommendation for changes and/or improvements.

  • Coordinates with functional department to resolve issues from validations.

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

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

  • Develop tracking mechanism of validation activity completion for various projects and prepare status report.

  • Present validation project and program status reports to senior management on a routine basis.

  • Ensures that validation status is maintained for equipment and software use in commercial and clinical manufacturing.

  • Train/advises less experienced Specialists.

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

  • Stays current with industry trends, regulatory requirement updates and communicating to teams.

  • May present at both internal and external (regulatory) audits.

  • Perform other duties assigned by management.

This role may be a fit for you if:

  • 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

  • Demonstrate respectful behavior at all times

  • 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

  • Seeks to identify continuous improvement needs

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

  • Associate QA Validation Specialist: 0-2 years of relevant experience

  • QA Validation Specialist: 2+ years of relevant experience

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

May substitute proven experience for education requirement.

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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)

$58,480.40 - $124,300.00