Assoc QA Validation Specialist

Regeneron Pharmaceuticals; City of Troy (NY); Sur place; USD 62 000 - 92 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals is seeking a candidate to validate and qualify equipment, systems, and processes in line with regulatory requirements. You will support manufacturing standards and procedures, and contribute to continuous improvement initiatives.

The role involves generating and reviewing protocols, data analysis, deviation investigations, and collaboration with internal teams and vendors. BS/BA in relevant fields with 0–2+ years’ experience preferred.

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences with 0-2+ years of related experience.
• Experience or familiarity with qualification/validation concepts is a plus.
• Strong communication and teamwork abilities.

Responsabilités

• Generate, execute and review qualification/validation protocols and reports.
• Analyze test results for conformance to criteria.
• Investigate issues and propose corrective actions.
• Review deviation notifications and change controls.
• Coordinate with other departments or vendors to complete tasks.
• Train less experienced staff and manage projects.

Connaissances

Communication skills

Teamwork

Time management

Independent work

Formation

BS/BA in Engineering or Chemistry or Life Sciences

Outils

Microsoft Word

Microsoft Excel

PowerPoint

Description du poste

Job Description

Summary: Validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures

Essential Duties and Responsibilities

include, but are not limited to, the following:

• 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.
• 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.
• Trains/advises less experienced Specialists.
• Manages projects and prepares status reports.
• May be required to oversee contingent workers.
• Other duties assigned by management.

Knowledge Skills & Abilities:

• 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

Education and Experience:

• BS/BA in Engineering, Chemistry, or Life Sciences with 0-2+ years of related experience within the field preferred; may substitute relevant experience for education.

Salary Range (annually)

$62,355.00 - $92,400.00

We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.